Contents
- His Excellency the Governor General in Council, on the rec…
- Interpretation
- Application
- Classification of Medical Devices
- Part 1 General
- Part 1.1 Medical Devices for an Urgent Public Health Need
- Part 2 Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access
- Part 3 Medical Devices for Investigational Testing Involving Human Subjects
- Part 4 Export Certificates
- Part 5 Transitional Provisions, Repeal and Coming into Force
- Schedule 1 Classification Rules for Medical Devices (Section 6)
- Schedule 2 Implants (Section 1)
- Schedule 3 Export Certificate for Medical Devices (Section 89)
- Related provisions
- Amendments not in force
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsections 3(3), 30(1) and 37(1) of the Food and Drugs Act, hereby makes the annexed Medical Devices Regulations.note
Interpretation
1#
The definitions in this section apply in these Regulations.
Act means the Food and Drugs Act. (Loi)
active device means a medical device that depends for its operation on a source of energy other than energy generated by the human body or gravity. A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device. (instrument actif)
active diagnostic device means an active device that, whether used alone or in combination with another medical device, is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity. (instrument diagnostique actif)
active therapeutic device means an active device that, whether used alone or in combination with another medical device, is intended to support, modify, replace or restore a biological function or structure for the purpose of treating or mitigating an illness or injury or a symptom of an illness or injury. (instrument thérapeutique actif)
(a)in respect of a decorative contact lens, the requirements set out in section 10, subsections 11(2) and 12(2) and sections 13 to 17; and
(b)in respect of any other medical device, the requirements set out in section 10, subsections 11(1) and 12(1) and sections 13 to 20. (exigences applicables prévues aux articles 10 à 20)
bar code means a unique bar code in the symbology of the Universal Product Code (UPC), the Health Industry Business Communications Council (HIBCC) or the European Article Number (EAN), assigned to a medical device by the manufacturer. (code à barres)
body orifice means a natural opening or a permanent artificial opening in the body, such as a stoma. (orifice du corps)
central cardiovascular system means the heart, pericardium, pulmonary veins, pulmonary arteries, cardiac veins, coronary arteries, common carotid arteries, cerebral arteries, brachiocephalic artery, aorta, inferior and superior vena cava, renal arteries, iliac arteries and femoral arteries. (système cardiovasculaire central)
central nervous system means the brain, meninges, spinal cord and cerebrospinal fluid. (système nerveux central)
closed-loop system, in respect of a medical device, means a system that enables the device to sense, interpret and treat a medical condition without human intervention. (système à boucle fermée)
Commissioner of Patents means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. (commissaire aux brevets)
control number means a unique series of letters, numbers or symbols, or any combination of these, that is assigned to a medical device by the manufacturer and from which a history of the manufacture, packaging, labelling and distribution of a unit, lot or batch of the device can be determined. (numéro de contrôle)
custom-made device means a medical device, other than a mass-produced medical device, that
(a)is manufactured in accordance with a health care professional’s written direction giving its design characteristics;
(b)differs from medical devices generally available for sale or from a dispenser; and
(c)is
(i)for the sole use of a particular patient of that professional, or
(ii)for use by that professional to meet special needs arising in the course of his or her practice. (instrument fait sur mesure)
decorative contact lens means a device referred to in section 2.1 of the Act. (lentilles cornéennes à but esthétique)
dental material [Repealed, SOR/2002-190, s. 1]
directions for use, in respect of a medical device, means full information as to the procedures recommended for achieving the optimum performance of the device, and includes cautions, warnings, contra-indications and possible adverse effects. (mode d’emploi)
dispenser means a person who is a member of a professional governing body and who is entitled, by virtue of their membership in that body, to manufacture or adapt a medical device in accordance with a health care professional’s written directions in order to meet the specific requirements of a patient. (préparateur)
General Council Decision has the meaning assigned by subsection 30(6) of the Act. (décision du Conseil général)
genetic testing means the analysis of DNA, RNA or chromosomes for purposes such as the prediction of disease or vertical transmission risks, or monitoring, diagnosis or prognosis. (test génétique)
health care facility means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. (établissement de santé)
health care professional means a person who is entitled under the laws of a province to provide health services in the province. (professionnel de la santé)
identifier means a unique series of letters or numbers or any combination of these or a bar code that is assigned to a medical device by the manufacturer and that identifies it and distinguishes it from similar devices. (identificateur)
implant means a medical device that is listed in Schedule 2. (implant)
invasive device means a medical device that is intended to come into contact with the surface of the eye or penetrate the body, either through a body orifice or through the body surface. (instrument effractif)
in vitro diagnostic device or IVDD means a medical device that is intended to be used in vitro for the examination of specimens taken from the body. (instrument diagnostique in vitro ou IDIV)
manufacturer means a person who sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. (fabricant)
medical device means a device within the meaning of the Act, but does not include any device that is intended for use in relation to animals. (instrument médical)
medical device family means a group of medical devices that are made by the same manufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use. (famille d’instruments)
medical device group means a medical device comprising a collection of medical devices, such as a procedure pack or tray, that is sold under a single name. (ensemble d’instruments)
medical device group family means a collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group. (famille d’ensembles d’instruments)
name of the device, in respect of a medical device, includes any information necessary for the user to identify the device and to distinguish it from similar devices. (nom de l’instrument)
near patient in vitro diagnostic device or near patient IVDD means an in vitro diagnostic device that is intended for use outside a laboratory, for testing at home or at the point of care, such as a pharmacy, a health care professional’s office or the bedside. (instrument diagnostique clinique in vitro)
objective evidence means information that can be proved true, based on facts obtained through observation, measurement, testing or other means, as set out in the definition objective evidence in section 2.19 of International Organization for Standardization standard ISO 8402:1994, Quality management and quality assurance - Vocabulary, as amended from time to time. (preuve tangible)
person includes a partnership and an association. (personne)
qualified investigator means a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care in the province and who is designated, by the ethics committee of the health care facility at which investigational testing is to be conducted, as the person to conduct the testing. (chercheur compétent)
quality management system certificate means a valid quality management system certificate described in paragraph 32(2)(f), 3(j) or (4)(p), as applicable, that is issued by a registrar recognized by the Minister under section 32.1. (certificat de système de gestion de la qualité)
quality system certificate [Repealed, SOR/2006-197, s. 1]
recall means
(b)any action taken by a manufacturer, importer or distributor of a medical device, after the device has been sold, to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device
(i)may present a risk of injury to health,
(ii)may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety, or
(iii)may not meet the requirements of the Act or these Regulations. (rappel)
regulatory agency means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements. (organisme de réglementation)
safety and effectiveness requirements [Repealed, SOR/2015-193, s. 1]
serious deterioration in the state of health means a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage. (détérioration grave de l’état de santé)
shortage, in respect of a medical device, means a situation in which the manufacturer of the device is unable to meet the demand for the device in Canada. (pénurie)
significant change means a change that could reasonably be expected to affect the safety or effectiveness of a medical device. It includes a change to any of the following:
(a)the manufacturing process, facility or equipment;
(b)the manufacturing quality control procedures, including the methods, tests or procedures used to control the quality, purity and sterility of the device or of the materials used in its manufacture;
(c)the design of the device, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories; and
(d)the intended use of the device, including any new or extended use, any addition or deletion of a contra-indication for the device and any change to the period used to establish its expiry date. (modification importante)
surgical or dental instrument means a reusable medical device that is intended for surgical or dental use, including cutting, drilling, sawing, scraping, clamping, hammering, puncturing, dilating, retracting or clipping, without connection to an active device. (instrument chirurgical ou dentaire)
surgically invasive device means an invasive device that is intended to enter the body through an artificially created opening that provides access to body structures and fluids. (instrument effractif chirurgical)
system means a medical device comprising a number of components or parts intended to be used together to fulfil some or all of the device’s intended functions, and that is sold under a single name. (système)
test kit means an in vitro diagnostic device that consists of reagents or articles, or any combination of these, and that is intended to be used to conduct a specific test. (trousse d’essai)
validation means confirmation by examination and the provision of objective evidence that the requirements for a specific intended use have been fulfilled, as set out in the definition validation in section 2.18 of International Organization for Standardization standard ISO 8402:1994, Quality management and quality assurance - Vocabulary, as amended from time to time. (validation)
Application
2#
These Regulations apply to
(a)the sale and advertising for sale of a medical device; and
(b)the importation of a medical device for sale or for use on individuals, other than importation for personal use.
2.1#
For greater certainty, these Regulations apply to a medical device that is a drug referred to in paragraph (b) or (c) of the definition biocide in subsection 1(1) of the Biocides Regulations.note
3#
(1)These Regulations also apply to an in vitro diagnostic product that is a drug or that contains a drug, as if the product were an in vitro diagnostic device.
(2)Subsection (1) does not apply to
(a)a drug listed in Schedule E or F to the Act;
(b)a drug listed in any of the schedules to the Controlled Substances Regulations; or
(c)a drug containing cannabis, as those terms are defined in subsection 1(2) of the Cannabis Regulations and subsection 2(1) of the Cannabis Act, respectively.
5#
These Regulations do not apply to a medical gas piping system that is assembled on site at a health care facility and permanently built into the structure of the facility.note
Classification of Medical Devices
6#
Medical devices are classified into one of Classes I to IV by means of the classification rules set out in Schedule 1, where Class I represents the lowest risk and Class IV represents the highest risk.
7#
If a medical device can be classified into more than one class, the class representing the higher risk applies.
Part 1 · General
Application
Manufacturer’s Obligations
9#
(1)A manufacturer shall ensure that the medical device meets the applicable requirements of sections 10 to 20.
(2)A manufacturer shall keep objective evidence to establish that the medical device meets those requirements.
Safety and Effectiveness Requirements
10#
A medical device shall be designed and manufactured to be safe, and to this end the manufacturer shall, in particular, take reasonable measures to
(a)identify the risks inherent in the device;
(b)if the risks can be eliminated, eliminate them;
(c)if the risks cannot be eliminated,
(i)reduce the risks to the extent possible,
(ii)provide for protection appropriate to those risks, including the provision of alarms, and
(iii)provide, with the device, information relative to the risks that remain; and
(d)minimize the hazard from potential failures during the projected useful life of the device.
note
11#
(1)A medical device other than a decorative contact lens shall not, when used for the medical conditions, purposes or uses for which it is manufactured, sold or represented, adversely affect the health or safety of a patient, user or other person, except to the extent that a possible adverse effect of the device constitutes an acceptable risk when weighed against the benefits to the patient and the risk is compatible with a high level of protection of health and safety.
(2)A decorative contact lens shall not adversely affect the health or safety of a user, except to the extent that a possible adverse effect of the device constitutes a risk that is compatible with a high level of protection of health and safety.
12#
(1)A medical device other than a decorative contact lens shall perform as intended by the manufacturer and shall be effective for the medical conditions, purposes and uses for which it is manufactured, sold or represented.
(2)A decorative contact lens shall perform as intended by the manufacturer.
13#
During the projected useful life of a medical device, its characteristics and performance shall not deteriorate under normal use to such a degree that the health or safety of a patient, user or other person is adversely affected.
14#
The characteristics and performance of a medical device shall not be adversely affected by transport or conditions of storage, taking into account the manufacturer’s instructions and information for transport and storage.
15#
Reasonable measures shall be taken to ensure that every material used in the manufacture of a medical device shall be compatible with every other material with which it interacts and with material that may come into contact with it in normal use, and shall not pose any undue risk to a patient, user or other person.
16#
The design, manufacture and packaging of a medical device shall minimize any risk to a patient, user or other person from reasonably foreseeable hazards, including
(a)flammability or explosion;
(b)presence of a contaminant or chemical or microbial residue;
(c)radiation;
(d)electrical, mechanical or thermal hazards; and
(e)fluid leaking from or entering into the device.
17#
A medical device that is to be sold in a sterile condition shall be manufactured and sterilized under appropriately controlled conditions, and the sterilization method used shall be validated.
18#
A medical device that is part of a system shall be compatible with every other component or part of the system with which it interacts and shall not adversely affect the performance of that system.note
19#
A medical device that performs a measuring function shall be designed to perform that function within tolerance limits that are appropriate for the medical conditions, purposes and uses for which the device is manufactured, sold or represented.
20#
If a medical device consists of or contains software, the software shall be designed to perform as intended by the manufacturer, and the performance of the software shall be validated.
Labelling Requirements
21#
(1)No person shall import or sell a medical device unless the device has a label that sets out the following information:
(a)the name of the device;
(b)the name and address of the manufacturer;
(c)the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(d)in the case of a Class III or IV device, the control number;
(e)if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;
(f)the word “Sterile”, if the manufacturer intends the device to be sold in a sterile condition;
(g)the expiry date of the device, if the device has one, to be determined by the manufacturer on the basis of the component that has the shortest projected useful life;
(h)unless self-evident to the intended user, the medical conditions, purposes and uses for which the device is manufactured, sold or represented, as well as the performance specifications of the device if those specifications are necessary for proper use;
(i)the directions for use, unless directions are not required
(i)in the case of a decorative contact lens, for the device to be used safely, and
(ii)in the case of any other medical device, for the device to be used safely and effectively; and
(j)any special storage conditions applicable to the device.
(2)The information required pursuant to subsection (1) shall be expressed in a legible, permanent and prominent manner, in terms that are easily understood by the intended user.
21.1#
Despite section 21, any person who imports for sale a medical device that is not labelled in accordance with these Regulations shall ensure
(a)if that person holds an establishment licence to import the medical device, that they send prior notice of the proposed importation to the Minister or, if they do not hold such a licence, that the manufacturer of the medical device sends the prior notice; and
(b)before selling the medical device, that the manufacturer of the medical device has relabelled it in accordance with these Regulations within three months after the date of its importation.
note
21.2#
Any person who imports for sale a medical device that is not labelled in accordance with these Regulations shall ensure that the manufacturer of the medical device notifies the Minister in writing of the name of the person who will relabel it in Canada if it is to be relabelled on the manufacturer’s behalf.note
22#
(1)Subject to subsection (2), if a medical device is intended to be sold to the general public, the information required by subsection 21(1) shall
(a)be set out on the outside of the package that contains the device; and
(b)be visible under normal conditions of sale.
(2)Where a package that contains a medical device is too small to display all the information in accordance with section 21, the directions for use shall accompany the device but need not be set out on the outside of the package or be visible under normal conditions of sale.
23#
(1)Subject to subsection (3), the information required by subsection 21(1) shall, as a minimum, be in either English or French.
(2)Subject to subsection (3), where the directions for use are supplied in only one official language at the time of sale, directions for use in the other official language shall be made available by the manufacturer as soon as possible at the request of the purchaser.
(3)In respect of a medical device to be sold to the general public, the information required by paragraphs 21(1)(a) and (e) to (j) shall, as a minimum, be in both English and French.
Contraceptive Devices — Advertising
24#
(1)For the purposes of subsections 3(1) and (2) of the Act and subject to section 27, a condom may be advertised and sold to the general public for the purpose of preventing the transmission of sexually transmitted diseases if the advertisement and the label of the condom claim only that the condom reduces the risk of transmitting sexually transmitted diseases.
(2)For the purpose of subsection 3(3) of the Act and subject to section 27, contraceptive devices, other than intrauterine devices, may be advertised to the general public by any means other than by the distribution of samples of the devices door-to-door or through the mail.
Class I Medical Devices
25#
(1)If the Minister believes on reasonable grounds, after reviewing a report or information brought to his or her attention, that a Class I medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before the day specified in the request, an analysis or other information to enable him or her to determine whether the device meets those requirements.
(2)The Minister may direct the manufacturer to stop the sale of the medical device if
(a)the manufacturer has not complied with the request on or before the day specified in the request; or
(b)the Minister determines, on the basis of the information submitted, that the device does not meet the applicable requirements of sections 10 to 20.
(3)The Minister shall lift the direction to stop the sale if
(a)the Minister determines, on the basis of the information submitted, that the medical device meets the applicable requirements of sections 10 to 20;
(b)corrective action has been taken to ensure that the medical device meets the applicable requirements of sections 10 to 20; or
(c)the Minister’s determination was unfounded.
Class II, III and IV Medical Devices
Prohibition
26#
Subject to section 37, no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence in respect of that device or, if the medical device has been subjected to a change described in section 34, an amended medical device licence.
27#
No person shall advertise a Class II, III or IV medical device for the purpose of sale unless
(a)the manufacturer of the device holds a licence in respect of that device or, if the device has been subjected to a change described in section 34, an amended medical device licence;
(a.1)the manufacturer of the device holds an authorization issued under section 68.12 in respect of that device or, if the device has been subjected to a change described in section 68.13, an amended authorization; or
(b)the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been licensed in accordance with Canadian law.
note
Medical Devices Deemed Licensed
28#
If a system is licensed, all of its components or parts that are manufactured by the manufacturer of the system are deemed, for the purposes of its importation, sale or advertisement, to have been licensed.
29#
If a test kit is licensed, all of its reagents or articles that are manufactured by the manufacturer of the test kit are deemed, for the purposes of its importation, sale or advertisement, to have been licensed.
30#
If a medical device or a medical device group is licensed and forms part of a medical device family or a medical device group family, as the case may be, all other medical devices or medical device groups in the family are deemed to have been licensed.
31#
(1)If all the medical devices that form part of a medical device group are licensed, that medical device group is deemed to have been licensed.
(2)If a medical device group is licensed, all the medical devices that form part of the medical device group are deemed, for the purposes of its importation, sale or advertisement, to have been licensed.
Application for a Medical Device Licence
32#
(1)An application for a medical device licence shall be submitted to the Minister by the manufacturer of the medical device in a format established by the Minister and shall contain the following:
(a)the name of the device;
(b)the class of the device;
(c)the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(d)the name and address of the manufacturer as it appears on the device label; and
(e)the name and address of the establishment where the device is being manufactured, if different from the one referred to in paragraph (d).
(2)An application for a Class II medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:
(a)a description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented;
(b)a list of the standards complied with in the manufacture of the device to satisfy the applicable requirements of sections 10 to 20;
(c)an attestation by a senior official of the manufacturer that the manufacturer has objective evidence to establish that the device meets the applicable requirements of sections 10 to 20;
(d)a copy of the device label;
(e)in the case of a near patient in vitro diagnostic device, an attestation by a senior official of the manufacturer that investigational testing has been conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use; and
(f)a copy of the quality management system certificate certifying that the quality management system under which the device is manufactured meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.
(3)An application for a Class III medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:
(a)a description of the device and of the materials used in its manufacture and packaging;
(b)a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented;
(c)a list of the countries other than Canada where the device has been sold, the total number of units sold in those countries, and a summary of any reported problems with the device and any recalls of the device in those countries;
(d)a list of the standards complied with in the design and manufacture of the device to satisfy the applicable requirements of sections 10 to 20;
(e)in the case of a device to be sold in a sterile condition, a description of the sterilization method used;
(f)a summary of all studies on which the manufacturer relies to ensure that the device meets the applicable requirements of sections 10 to 20, and the conclusions drawn from those studies by the manufacturer;
(g)a copy of the device label;
(h)in the case of a near patient in vitro diagnostic device, a summary of investigational testing conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use;
(i)a bibliography of all published reports dealing with the use, safety and effectiveness of the device; and
(j)a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.
(4)An application for a Class IV medical device licence shall contain, in addition to the information and documents set out in subsection (1), the following:
(a)a description of the device and of the materials used in its manufacture and packaging;
(b)a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented;
(c)a list of the countries other than Canada where the device has been sold, the total number of units sold in those countries, and a summary of any reported problems with the device and any recalls of the device in those countries;
(d)a risk assessment comprising an analysis and evaluation of the risks, and the risk reduction measures adopted to satisfy the applicable requirements of sections 10 to 20;
(e)a quality plan setting out the specific quality practices, resources and sequence of activities relevant to the device;
(f)the specifications of the materials used in the manufacture and packaging of the device;
(g)the manufacturing process of the device;
(h)a list of the standards complied with in the design and manufacture of the device to satisfy the applicable requirements of sections 10 to 20;
(i)detailed information on all studies on which the manufacturer relies to ensure that the device meets the applicable requirements of sections 10 to 20, including
(i)pre-clinical and clinical studies,
(ii)process validation studies,
(iii)if appropriate, software validation studies, and
(iv)literature studies;
(j)in the case of a medical device other than an in vitro diagnostic device, manufactured from or incorporating animal or human tissue or their derivative, objective evidence of the biological safety of the device;
(k)in the case of a near patient in vitro diagnostic device, detailed information on investigational testing conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use;
(l)a summary of the studies referred to in paragraph (i) and the conclusions drawn from those studies by the manufacturer;
(m)a summary of the investigational testing referred to in paragraph (k) and the conclusions drawn from that testing by the manufacturer;
(n)a bibliography of all published reports dealing with the use, safety and effectiveness of the device;
(o)a copy of the device label; and
(p)a copy of the quality management system certificate certifying that the quality management system under which the device is designed and manufactured meets the requirements set out in the National Standard of Canada CAN/CSA-ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, as amended from time to time.
Quality Management System Certificate
32.1#
The Minister shall recognize a person as a registrar for the purpose of issuing, renewing, suspending or cancelling quality management system certificates if the person
(a)has sufficient training, experience and technical knowledge in the design and manufacture of medical devices and in the effective implementation of quality management systems to determine whether a quality management system satisfies a standard referred to in paragraph 32(2)(f), (3)(j) or (4)(p); and
note
32.2#
A quality management system certificate is valid for the period, not exceeding three years, specified in it.note
32.3#
A registrar shall notify the Minister in writing within 15 days after suspending or cancelling a quality management system certificate.note
32.4#
A registrar shall notify the Minister in writing within 15 days after the expiry of a quality management system certificate if the certificate has not been renewed.note
32.5#
(2)Subject to section 32.6, the Minister shall not cease to recognize a person as a registrar unless
(a)the Minister has sent the registrar a written notice that sets out the reason for the proposed cessation of recognition, any corrective action required to be taken and the time within which it must be taken;
(b)if corrective action is required, the time set out in the notice has passed without the action having been taken; and
(c)the registrar has been given an opportunity to be heard in respect of the proposed cessation of recognition.
note
32.6#
(1)The Minister may cease to recognize a person as a registrar without giving the registrar an opportunity to be heard if it is necessary to do so to prevent injury to the health or safety of patients, users or other persons, by giving the registrar a notice in writing that states the reason for the cessation of recognition.
(2)A registrar may ask the Minister, in writing, that the cessation of recognition be reconsidered.
(3)The Minister shall, within 45 days after the date of receiving the request for reconsideration, provide the registrar with an opportunity to be heard.
note
Foreign Manufacturers
33#
(1)If an application for a medical device licence is submitted by a manufacturer of a country other than Canada, the information and documents described in subsections 32(2) to (4) need not be submitted if
(a)the applicant is governed, in that country, by a regulatory authority that is recognized by the Minister; and
(b)the application is accompanied by a certificate of compliance and a supporting summary report, issued by a conformity assessment body of that country that is recognized by the Minister, which certify that the medical device meets the applicable requirements of sections 10 to 20.
(2)For the purposes of subsection (1), the Minister may recognize a regulatory authority and a conformity assessment body of a country other than Canada only if it has the ability to determine whether the device meets the applicable requirements of sections 10 to 20.
(3)The Minister shall, on request, make available to any interested persons the list of recognized regulatory authorities and conformity assessment bodies of countries other than Canada.
Application for a Medical Device Licence Amendment
34#
If the manufacturer proposes to make one or more of the following changes, the manufacturer shall submit to the Minister, in a format established by the Minister, an application for a medical device licence amendment including the information and documents set out in section 32 that are relevant to the change:
(a)in the case of a Class III or IV medical device, a significant change;
(b)a change that would affect the class of the device;
(c)a change in the name of the manufacturer;
(d)a change in the name of the device;
(e)a change in the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(f)in the case of a Class II medical device other than a decorative contact lens, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.
note
Additional Information and Samples
35#
(1)If the information and documents submitted in respect of an application for a medical device licence or a medical device licence amendment are insufficient to enable the Minister to determine whether a medical device meets the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before a specified day, additional information necessary for making the determination.
(2)In the course of examining the application, the Minister may require the applicant to provide samples of the medical device.
Issuance
36#
(1)If the Minister determines that a medical device in respect of which an application is submitted meets the applicable requirements of sections 10 to 20, the Minister shall
(a)issue to the manufacturer of the device a medical device licence, in the case of an application for a medical device licence; or
(b)amend the medical device licence, in the case of an application for a medical device licence amendment.
(2)The Minister may, at any time, impose terms and conditions on a medical device licence or amend such terms and conditions after considering
(a)whether there are uncertainties relating to the benefits or risks associated with the device;
(b)whether the requirements under the Act are sufficient for the following objectives to be met:
(i)maintaining the safety and effectiveness of the device,
(ii)optimizing the benefits and managing the risks associated with the device, and
(iii)identifying any changes relating to those benefits and risks and managing uncertainties related to the benefits and risks;
(c)whether the proposed terms and conditions may contribute to those objectives being met;
(d)whether compliance with the proposed terms and conditions is technically feasible; and
(e)whether there are less burdensome ways for those objectives to be met.
(3)[Repealed, SOR/2024-238, s. 41] (repealed)
(4)[Repealed, SOR/2024-238, s. 41] (repealed)
Lot of In Vitro Diagnostic Devices
37#
If the terms and conditions of a medical device licence for an in vitro diagnostic device require that tests be performed to ensure that the device continues to meet the applicable requirements set out in sections 10 to 20, no person shall sell a device from a lot of the in vitro diagnostic device unless
(a)the results and protocols of the tests performed on devices in the lot have been provided to the Minister; and
(b)the Minister determines, on the basis of the results and protocols provided that the devices in the lot continue to meet the applicable requirements set out in sections 10 to 20.
note
Refusal to Issue
38#
(1)The Minister may refuse to issue or amend a medical device licence if
(a)the applicant does not comply with these Regulations or any provisions of the Act relating to medical devices;
(b)the applicant has made a false or misleading statement in the application;
(c)the medical device does not comply with the labelling requirements set out in sections 21 to 23; or
(d)the applicant has not complied with a request for additional information or samples made pursuant to section 35 by the day specified in the request.
(2)The Minister shall refuse to issue or amend a medical device licence if the medical device does not meet the applicable requirements of sections 10 to 20 or if the information or samples provided pursuant to section 35 are insufficient to enable the Minister to determine whether the medical device meets those requirements.
(3)If the Minister refuses to issue or amend a medical device licence, the Minister shall
(a)notify the applicant in writing of the reasons for the refusal; and
(b)give the applicant an opportunity to be heard.
Requests by Minister
39#
If the Minister believes on reasonable grounds, after reviewing a report or information brought to his or her attention, that a licensed medical device may not meet the applicable requirements of sections 10 to 20, the Minister may request the manufacturer to submit, on or before the day specified in the request, samples — or an analysis or other information — to enable him or her to determine whether the device meets those requirements.note
Suspension
40#
(1)Subject to subsection (3), the Minister may suspend a medical device licence if the Minister has reasonable grounds to believe that
(a)the licensee has contravened these Regulations or any provision of the Act relating to medical devices;
(b)the licensee has made a false or misleading statement in the application;
(c)the licensee has failed to comply with the terms and conditions of the licence;
(d)the licensee has not complied with a request made under section 39 on or before the day specified in the request;
(d.1)the samples — or the analysis or other information — submitted by the licensee in response to a request made under section 39 are insufficient to enable the Minister to determine whether the medical device meets the applicable requirements of sections 10 to 20;
(e)the medical device no longer meets the applicable requirements of sections 10 to 20; or
(f)on the basis of information obtained after the device was licensed, the quality management system under which the device has been designed, in the case of a Class III or IV device, or manufactured, assembled, processed, packaged, refurbished or modified, in the case of a Class II, III or IV device, is inadequate to ensure that the device meets its specifications.
(2)Before suspending a medical device licence, the Minister shall consider
(a)the licensee’s history of compliance with these Regulations and with the provisions of the Act relating to medical devices; and
(b)the risk that allowing the licence to continue to be in force would constitute for the health or safety of patients, users or other persons.
(3)Subject to section 41, the Minister shall not suspend a medical device licence until
(a)the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;
(b)if corrective action is required, the time set out in the notice has passed without the action having been taken; and
(c)the licensee has been given an opportunity to be heard in respect of the suspension.
41#
(1)The Minister may suspend a medical device licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health or safety of patients, users or other persons, by giving the licensee a notice in writing that states the reason for the suspension.
(2)A licensee may ask the Minister, in writing, that the suspension be reconsidered.
(3)The Minister shall, within 45 days after the date of receiving the request, provide the licensee with an opportunity to be heard.
41.1#
The Minister may suspend a medical device licence if, after he or she has, under section 21.31 of the Act, ordered the licensee to conduct an assessment of the medical device in order to provide evidence establishing that the benefits associated with the device outweigh the risks to the health or safety of patients, users or other persons,
(a)the licensee has not complied with the order; or
(b)the licensee has complied with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the device outweigh the risks to the health or safety of patients, users or other persons.
note
42#
The Minister may reinstate a medical device licence if the situation giving rise to the suspension has been corrected or if the reason for the suspension was unfounded.
Obligation to Inform
43#
(1)Every manufacturer of a licensed medical device shall, annually before November 1 and in a form authorized by the Minister, furnish the Minister with a statement signed by the manufacturer or by a person authorized to sign on the manufacturer’s behalf
(a)confirming that all the information and documents supplied by the manufacturer with respect to the device are still correct; or
(b)describing any change to the information and documents supplied by the manufacturer with respect to the device, other than those to be submitted under section 34 or 43.1.
(2)If the manufacturer fails to comply with subsection (1), the Minister may cancel the medical device licence.
(3)If the holder of a medical device licence discontinues the sale of the medical device in Canada, the licensee shall inform the Minister within 30 days after the discontinuation, and the licence shall be cancelled at the time that the Minister is informed.
Obligation to Submit Certificate
43.1#
Subject to section 34, if a new or modified quality management system certificate is issued in respect of a licensed medical device, the manufacturer of the device shall submit a copy of the certificate to the Minister within 30 days after it is issued.note
Disclosure of Information in Respect of Clinical Studies or Investigational Testing
43.11#
In sections 43.12 and 43.13, information in respect of a clinical study or investigational testing means information in respect of a clinical study, or investigational testing, involving human subjects that is contained in an application for a Class III or IV medical device licence made under section 32 or in an application to amend such a licence made under section 34.note
43.12#
(1)Information in respect of a clinical study or investigational testing that is confidential business information ceases to be confidential business information when one of the following circumstances occurs with respect to the application:
(a)the Minister issues a licence under paragraph 36(1)(a);
(b)the Minister amends a licence under paragraph 36(1)(b);
(c)the Minister refuses to issue a licence or amend a licence under section 38.
(2)Subsection (1) does not apply to information in respect of a clinical study or investigational testing that
(a)was not used by the manufacturer in the application to support the information referred to in paragraph 32(3)(b) or paragraph 32(4)(b); or
(b)describes tests, methods or assays that are used exclusively by the manufacturer.
note
Medical Devices to Be Sold for the Purposes of Implementing the General Council Decision
Application
43.2#
Sections 43.3 to 43.6 apply, for the purposes of implementing the General Council Decision, to a medical device in respect of which a manufacturer has applied to the Commissioner of Patents for an authorization under section 21.04 of the Patent Act.note
Notices to Commissioner of Patents
43.3#
The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s medical device meets the requirements of the Act and these Regulations if
(a)the manufacturer holds a medical device licence in respect of the device issued in accordance with section 36;
(b)the Minister is satisfied that the manufacturer and the device comply with the Act and these Regulations;
(c)the manufacturer has submitted to the Minister a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;
(d)the manufacturer has submitted to the Minister information regarding the manner in which the mark referred to in paragraph 43.5(1)(a) is applied to all permanent components of the device; and
(e)the manufacturer has submitted to the Minister a sample of the label for the device that includes the information required by paragraph 43.5(1)(b).
note
43.4#
The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer’s medical device referred to in section 43.2 has ceased to meet the requirements of the Act and these Regulations.note
Marking and Labelling
43.5#
(1)No person shall sell a medical device referred to in section 43.2 unless
(a)the mark “XCL” is displayed on all permanent components of the device; and
(b)the label of the device displays the mark “XCL” followed by the control number referred to in paragraph 21(1)(d) and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.”.
(2)The information required by subsection (1) shall be expressed in a legible, permanent and prominent manner.
note
Notice to Minister
43.6#
The manufacturer of a medical device referred to in section 43.2 shall notify the Minister in writing not less than 15 days prior to commencing the manufacture of the device.note
Establishment Licence
Prohibition
44#
(1)No person shall import or sell a medical device unless the person holds an establishment licence.
(2)Subsection (1) does not apply to the importation or sale of a medical device by
(a)a retailer;
(b)a health care facility;
(c)in the case of a Class II, III or IV medical device, the manufacturer of the medical device; or
(d)in the case of a Class I device, the manufacturer of the medical device, if the manufacturer imports or distributes solely through a person who holds an establishment licence.
(3)Any person who imports a medical device shall ensure that the person from whom they import it holds an establishment licence.
(4)Subsection (3) does not apply where a person imports
(a)in the case of a Class I medical device, from the manufacturer of that medical device if the person importing it holds an establishment licence; and
(b)in the case of a Class II, III or IV medical device, from the manufacturer of that medical device.
Application
45#
A person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information and documents:
(a)the name and address of the establishment;
(a.1)any other name under which the person previously conducted activities under these Regulations;
(b)the name, title and contact information of the representative of the establishment to contact for information concerning the application;
(c)a statement as to whether the activity of the establishment is importation or distribution, or both;
(d)the names and addresses of the manufacturers of the devices that are being imported or distributed;
(e)for each manufacturer, in respect of a medical device other than a decorative contact lens, the medical specialities in respect of which the device is imported or distributed;
(f)for each manufacturer, the classes of the devices that are being imported or distributed;
(g)an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of distribution records, complaint handling and recalls;
(h)if the establishment imports Class I medical devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of the making of reports under subsections 59(1) and (1.1);
(h.1)if the establishment imports Class II, III or IV medical devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place in respect of the making of reports under subsection 59(1) and the provision of information under section 61.2;
(i)if the establishment imports or distributes Class II, III or IV devices, an attestation by a senior official of the establishment that the establishment has documented procedures in place, where applicable, for handling, storage, delivery, installation, corrective action and servicing in respect of those devices; and
(j)the address of each building where the procedures described in paragraphs (g) to (i) are in place.
note
Issuance
Annual Review of Licence
46.1#
(1)The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referred to in section 45.
(2)The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession.
note
Refusal
47#
(1)The Minister may refuse to issue an establishment licence if the applicant has made a false or misleading statement in the application.
(2)The Minister shall refuse to issue an establishment licence if the Minister has reasonable grounds to believe that issuing such a licence would constitute a risk to the health or safety of patients, users or other persons.
(3)If the Minister refuses to issue an establishment licence, the Minister shall
(a)notify the applicant in writing of the reasons for the refusal; and
(b)give the applicant an opportunity to be heard.
Notification
Terms and Conditions
48.1#
The Minister may, at any time, impose terms and conditions on an establishment licence, or amend those terms and conditions, after considering the following factors:
(a)whether there are uncertainties relating to the manner in which an activity is or will be conducted;
(b)whether the requirements under the Act are sufficient to protect patients, users or other persons from risks to health or safety;
(c)whether compliance with the proposed terms and conditions is feasible; and
(d)whether there are less burdensome ways to meet the objectives of the proposed terms and conditions.
note
Suspension
49#
(1)Subject to subsection (3), the Minister may suspend an establishment licence if the Minister has reasonable grounds to believe that
(a)the licensee has contravened these Regulations or any provision of the Act relating to medical devices;
(b)the licensee has made a false or misleading statement in the application; or
(c)failure to suspend the establishment licence would constitute a risk to the health or safety of patients, users or other persons.
(2)Before suspending an establishment licence, the Minister shall consider
(a)the licensee’s history of compliance with these Regulations and with the provisions of the Act relating to medical devices; and
(b)the risk that allowing the licence to continue to be in force would constitute for the health or safety of patients, users or other persons.
(3)Subject to section 50, the Minister shall not suspend an establishment licence until
(a)the Minister has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;
(b)if corrective action is required, the time set out in the notice has passed without the action having been taken; and
(c)the licensee has been given an opportunity to be heard in respect of the suspension.
note
50#
(1)The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent risk to the health or safety of patients, users or other persons, by giving the licensee a notice in writing that states the reason for the suspension.
(2)A licensee may ask the Minister, in writing, that the suspension be reconsidered.
(3)The Minister shall, within 45 days after the date of receiving the request, provide the licensee with an opportunity to be heard.
Cancellation
51.1#
The Minister shall cancel an establishment licence in either of the following circumstances:
(a)the licence has been suspended for a period of more than 12 months, or
(b)the licence holder has failed to submit an application for the review of their licence in accordance with subsection 46.1(1).
note
Distribution Records
52#
(1)The manufacturer, importer and distributor of a medical device shall each maintain a distribution record in respect of each device.
(2)Subsection (1) does not apply to
(a)a retailer; or
(b)a health care facility in respect of a medical device that is distributed for use within that facility.
53#
The distribution record shall contain sufficient information to permit the complete and rapid recall of the medical device.note
54#
(1)The distribution record maintained by a manufacturer of an implant shall also contain a record of the information received on the implant registration cards forwarded to the manufacturer from a health care facility pursuant to section 67.
(2)The manufacturer of an implant shall update the information referred to in subsection (1) in accordance with any information received from the health care facility or the patient.
55#
The manufacturer, importer and distributor shall retain the distribution record maintained in respect of a medical device for the longer of
(a)the projected useful life of the device, and
(b)two years after the date the device is shipped.
Complaint Handling
57#
(1)The manufacturer, importer and distributor of a medical device shall each maintain records of the following:
(a)reported problems relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer, importer or distributor after the device was first sold in Canada; and
(b)all actions taken by the manufacturer, importer or distributor in response to the problems referred to in paragraph (a).
(2)Subsection (1) does not apply to
(a)a retailer; or
(b)a health care facility in respect of a medical device that is distributed for use within that facility.
58#
The manufacturer, importer and distributor of a medical device shall each establish and implement documented procedures that will enable the manufacturer, importer or distributor to carry out
(a)an effective and timely investigation of the problems referred to in paragraph 57(1)(a); and
(b)an effective and timely recall of the device.
Incident Reporting
59#
(1)The manufacturer and the importer of a medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring in Canada that involves the device if
(a)the device is sold in Canada; and
(b)the incident
(i)is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use, and
(ii)has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were the incident to recur.
(1.1)Subject to subsection (2), the manufacturer and the importer of a Class I medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring outside Canada that involves the device if the conditions in paragraphs (1)(a) and (b) are met.
(2)The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated, to a regulatory agency of the country in which the incident occurred, the manufacturer’s intention to take corrective action, or unless the regulatory agency has required the manufacturer to take corrective action.
note
60#
(1)A preliminary report shall be submitted to the Minister
(a)in respect of an incident that occurs in Canada
(i)within 10 days after the manufacturer or importer of a medical device becomes aware of an incident, if the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person, or
(ii)within 30 days after the manufacturer or importer of a medical device becomes aware of an incident, if the incident has not led to the death or a serious deterioration in the state of health of a patient, user or other person, but could do so were it to recur; and
(b)in respect of an incident that occurs outside Canada, as soon as possible after the manufacturer has indicated, to the regulatory agency referred to in paragraph 59(2), the manufacturer’s intention to take corrective action, or after the regulatory agency has required the manufacturer to take corrective action.
(2)The preliminary report shall contain the following information:
(a)the name of the device and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(b)if the report is made by
(i)the manufacturer, the name and address of that manufacturer and of any known importer, and the name, title and telephone and facsimile numbers of a representative of the manufacturer to contact for any information concerning the incident, or
(ii)the importer of the device, the name and address of the importer and of the manufacturer, and the name, title and telephone and facsimile numbers of a representative of the importer to contact for any information concerning the incident;
(c)the date on which the incident came to the attention of the manufacturer or importer;
(d)the details known in respect of the incident, including the date on which the incident occurred and the consequences for the patient, user or other person;
(e)the name, address and telephone number, if known, of the person who reported the incident to the manufacturer or importer;
(f)the identity of any other medical devices or accessories involved in the incident, if known;
(g)the manufacturer’s or importer’s preliminary comments with respect to the incident;
(h)the course of action, including an investigation, that the manufacturer or importer proposes to follow in respect of the incident and a timetable for carrying out any proposed action and for submitting a final report; and
(i)a statement indicating whether a previous report has been made to the Minister with respect to the device and, if so, the date of the report.
61#
(1)After the preliminary report is made in accordance with section 60, a final report shall be submitted to the Minister in accordance with the timetable established under paragraph 60(2)(h).
(2)The final report shall contain the following information:
(a)a description of the incident, including the number of persons who have experienced a serious deterioration in the state of their health or who have died;
(b)a detailed explanation of the cause of the incident and a justification for the actions taken in respect of the incident; and
(c)any actions taken as a result of the investigation referred to in paragraph 60(2)(h), which may include
(i)increased post-market surveillance of the device,
(ii)corrective and preventive action respecting the design and manufacture of the device, and
(iii)recall of the device.
note
61.1#
(1)Despite subsection 59(1) or (1.1), the manufacturer of a medical device may permit the importer of the device to prepare and submit the preliminary and final reports on the manufacturer’s behalf if the information that the manufacturer and the importer must include is identical.
(2)The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to prepare and submit the reports on the manufacturer’s behalf.
note
Serious Risk of Injury to Human Health
61.2#
(1)This section applies to a holder of one of the following therapeutic product authorizations:
(a)a medical device licence; and
(b)an establishment licence to import Class II, III or IV medical devices.
(2)The holder of a therapeutic product authorization issued in respect of a medical device shall submit to the Minister information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of the device, regarding
(a)risks that have been communicated by any regulatory agency that is set out in the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a medical device within the jurisdiction of such a regulatory agency, and the manner of the communication;
(b)changes that have been made to the labelling of any medical device and that have been communicated to or requested by any regulatory agency that is set out in the list referred to in paragraph (a); and
(c)recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any medical device, that have taken place within the jurisdiction of any regulatory agency that is set out in the list referred to in paragraph (a).
(3)The information shall be submitted to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.
note
61.3#
(1)Despite subsection 61.2(2), if the holder of a therapeutic product authorization issued in respect of a medical device is the manufacturer, they may permit the importer of the device to submit the information required under that subsection on the manufacturer’s behalf if the information that the manufacturer and the importer must submit is identical.
(2)The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to submit the information on the manufacturer’s behalf.
note
Summary Report
61.4#
(1)The holder of a medical device licence shall prepare
(a)in the case of a Class II medical device, on a biennial basis, a summary report of the information referred to in subsection (2) that the holder received or became aware of during the previous 24 months; and
(b)in the case of a Class III or IV medical device, on an annual basis, a summary report of the information referred to in subsection (2) that the holder received or became aware of during the previous 12 months.
(2)The information to be covered by the summary report is that in respect of
(a)adverse effects;
(b)problems referred to in paragraph 57(1)(a);
(c)incidents referred to in subsection 59(1); and
(d)serious risks of injury to human health that are relevant to the safety of the medical device and are referred to in subsection 61.2(2).
(3)The summary report shall contain a concise critical analysis of the information referred to in subsection (2).
(4)In preparing the summary report, the holder shall determine, on the basis of the critical analysis, whether what is known about the benefits and risks associated with the medical device has changed in any of the following ways:
(a)the potential benefits for patients through the use of the device may be less;
(b)in respect of each of the risks,
(i)the harm associated with the risk is more likely to occur, or
(ii)if the harm associated with the risk occurs, the consequences for the health or safety of patients, users or other persons could be more serious; and
(c)a new risk has been identified.
(5)The holder shall include the conclusions they reach under subsection (4) in the summary report.
(6)If, in preparing the summary report, the holder concludes that what is known about the benefits and risks associated with the medical device has changed in any of the ways referred to in paragraphs (4)(a) to (c), they shall notify the Minister, in writing, within 72 hours after having reached the conclusion, unless that has already been done.
note
61.5#
(1)The Minister may, for the purposes of determining whether a medical device meets the applicable requirements of sections 10 to 20, request that the holder of a medical device licence issued in respect of the device submit, within a specified time limit, any of the following:
(a)summary reports; or
(b)information on the basis of which summary reports were prepared.
(2)The holder shall submit to the Minister the summary reports or information, or both, that the Minister requests within the time limit specified in the request.
note
61.6#
(1)The holder of a medical device licence shall maintain records of the summary reports and the information on the basis of which those reports were prepared.
(2)The holder shall retain the records for seven years after the day on which they were created.
note
Provision of Information Under Section 21.8 of Act
62#
(1)For the purposes of section 21.8 of the Act, hospitals are the prescribed health care institutions that shall provide information that is in their control to the Minister about a medical device incident.
(2)The following prescribed information about a medical device incident that is in a hospital’s control shall be provided to the Minister in writing within 30 days after the day on which the medical device incident is first documented within the hospital:
(b)the name or identifier of the medical device;
(c)the date on which the medical device incident was first documented;
(d)the name of the manufacturer of the medical device;
(e)a description of the medical device incident;
(f)the lot number of the device or its serial number;
(g)any contributing factors to the medical device incident, including any medical condition of the patient that directly relates to the medical device incident; and
(h)the effect of the medical device incident on the patient’s health.
(3)A hospital is exempt from section 21.8 of the Act in respect of the reporting of information referred to in subsection (2) if
(a)the hospital does not have in its control all of the information referred to in paragraphs (2)(b) and (e) in respect of the medical device incident; or
(b)the medical device incident involves only a medical device that is the subject of an authorization issued under subsection 72(1) or 83(1).
(4)The following definitions apply in this section.
hospital means a facility
(a)that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or
(b)that is operated by the Government of Canada and that provides health services to in-patients. (hôpital)
medical device incident means an incident related to a failure of a medical device, a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user or other person or could do so were it to recur. (incident lié à un instrument médical)
(5)For the purposes of the Act, medical device incident has the same meaning as in subsection (4).
note
Assessments Ordered Under Section 21.31 of the Act
62.1#
(1)The Minister’s power to make an order under section 21.31 of the Act in respect of a medical device is subject to the following conditions:
(a)the person to whom the order is made shall be the holder of a medical device licence issued in respect of the device; and
(b)the Minister shall have reasonable grounds to believe that the benefits — or the risks to the health or safety of patients, users or other persons — that are associated with the device are significantly different than they were when the medical device licence was issued or amended.
(2)The Minister shall, after examining the results of an assessment that was ordered under section 21.31 of the Act in respect of a medical device,
(a)provide the holder of the medical device licence issued in respect of the device with the results of the examination; and
(b)ensure that a summary of the results of the examination, together with a description of any steps that the Minister has taken or may take as a consequence of the examination, is published on the Government of Canada website.
note
Activities Ordered Under Section 21.32 of the Act
62.2#
The Minister’s power to make an order under section 21.32 of the Act in respect of a medical device is subject to the following conditions:
(a)the person to whom the order is made shall be the holder of a medical device licence issued in respect of the device;
(b)the Minister shall have reasonable grounds to believe that
(i)there are significant uncertainties relating to the benefits or adverse effects associated with the device,
(ii)the licensee is unable to provide the Minister with information that is sufficient to manage those uncertainties, and
(iii)the applicable requirements of these Regulations, together with any terms and conditions that have been imposed on the medical device licence, do not allow for sufficient information to be obtained to manage those uncertainties; and
(c)the Minister shall take into account the following matters:
(i)whether the activities that the licensee will be ordered to undertake are feasible, and
(ii)whether there are less burdensome ways of obtaining additional information about the device’s effects on the health or safety of patients, users or other persons.
note
Shortages
62.21#
The following definitions apply in this section and in sections 62.22 to 62.26.
List of Medical Devices – Notification of Shortages means the List of Medical Devices – Notification of Shortages that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux – avis de pénuries)
specified medical device means a medical device that belongs to a category of medical devices that is set out in the List of Medical Devices – Notification of Shortages. (instrument médical inscrit)
note
62.22#
The Minister may add a category of medical devices to the List of Medical Devices – Notification of Shortages only if the Minister has reasonable grounds to believe that a shortage of a device that belongs to the category presents or may present a risk of injury to human health.note
62.23#
(1)Subject to subsections (2), (7) and (9), if a shortage of a specified medical device exists or is likely to occur, the manufacturer of the device and, in the case of a Class I device, the importer of the device shall each provide the following information to the Minister electronically in a format specified by or acceptable to the Minister:
(a)the name and contact information of the manufacturer and, if the information is provided by the importer, the name and contact information of the importer;
(b)in the case of a licensed device, the medical device licence number;
(b.1)in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;
(c)the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(d)the name of the device, including, if applicable, the model name, in English and French;
(e)a description of the device and of its packaging and an indication of whether it is a single-use device;
(f)the date when the shortage began or is anticipated to begin;
(g)the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated;
(h)the reason for the shortage; and
(i)a summary of the information that the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur.
(2)If the manufacturer of a specified medical device decides to discontinue the sale of the device in Canada, the following rules apply:
(a)the manufacturer or importer is required to provide only the information referred to in paragraphs (1)(a) to (f) in respect of the shortage that results from the decision and shall also provide under subsection (1) the reason for the discontinuation; and
(b)paragraph 4(a) does not apply to the manufacturer.
(3)For greater certainty, subsections (1) and (2) do not remove the requirement for
(a)a manufacturer that is the holder of a medical device licence to inform the Minister under subsection 43(3); or
(b)a manufacturer that is the holder of an authorization issued under section 68.12 to inform the Minister under section 68.25.
(4)Subject to subsection (8), the information that is required under subsection (1) shall be provided
(a)if the manufacturer or importer did not anticipate the shortage, within five business days after the day on which the manufacturer or importer becomes aware of it; and
(b)if the manufacturer or importer anticipates that there will be a shortage, within five business days after the day on which the manufacturer or importer anticipates it.
(5)If any of the information that was provided under subsection (1) changes, the manufacturer or importer shall provide the new information to the Minister electronically in a format specified by or acceptable to the Minister within two business days after the day on which the manufacturer or importer makes or becomes aware of the change.
(6)Within two business days after the day on which the manufacturer is again able to meet the demand for the specified medical device, the manufacturer or importer shall notify the Minister electronically in a format specified by or acceptable to the Minister of the manufacturer’s ability to do so.
(7)The manufacturer or importer need not provide the information that is required under subsection (1) if, within the applicable period referred to in paragraph (4)(a) or (b), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the specified medical device within 30 days after the day on which the manufacturer or importer anticipated or became aware of the shortage.
(8)Despite subsection (7), if the manufacturer or importer subsequently concludes that the manufacturer will be unable to meet the demand within the 30-day period, the manufacturer or the importer shall provide the information that is required under subsection (1) within five business days after the day on which the manufacturer or importer reaches that conclusion.
(9)The manufacturer or importer need not provide the information that is required under subsection (1) if the manufacturer
(a)is also the manufacturer of another medical device that can be substituted for the specified medical device in respect of which a shortage exists or is likely to occur; and
(b)is able to meet the demand for the substitute medical device.
note
62.24#
(1)Despite section 62.23, the manufacturer of a specified medical device may permit the importer of the device to provide the information that is required under that section on the manufacturer’s behalf if the information that the manufacturer and importer must provide is identical.
(2)The manufacturer shall notify the Minister electronically in a format specified by or acceptable to the Minister if the manufacturer has permitted the importer to provide the information on the manufacturer’s behalf.
note
62.25#
(1)The Minister shall publish, on the Government of Canada website, the information that the Minister receives under section 62.23, other than the information referred to in subparagraph 62.23(1)(i).
(2)Subsection (1) does not apply if the Minister has reasonable grounds to believe that a situation, in respect of which information was provided under section 62.23, does not constitute a shortage.
note
62.26#
(1)The Minister may request that the manufacturer of a medical device — or any importer or distributor of a medical device — provide the Minister with information that is in their control if the Minister has reasonable grounds to believe that
(b)a shortage of the device, if it were to occur, could present a risk of injury to human health;
(c)the information is necessary to establish or assess
(iii)the effects or potential effects on human health of a shortage of the device,
(iv)measures that could be taken to prevent or mitigate shortage risks associated with the device, or
(v)measures that could be taken to mitigate the impacts of a shortage of the device; and
(d)the manufacturer, importer or distributor will not provide the information without a legal obligation to do so.
(2)The manufacturer, importer or distributor shall provide the requested information in the time, form and manner specified by the Minister.
note
62.27#
The following definitions apply in this section and in sections 62.28 to 62.321.
designated medical device means a medical device that is set out in the List of Medical Devices for Exceptional Importation and Sale. (instrument médical désigné)
List of Medical Devices for Exceptional Importation and Sale means the List of Medical Devices for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés aux importations et aux ventes exceptionnelles)
note
62.28#
The Minister may add a medical device to the List of Medical Devices for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that
(a)there is a shortage or risk of shortage of another medical device;
(a.1)a shortage of the device referred to in paragraph (a), if it were to occur, could present a risk of injury to human health;
(b)the device to be added to that list can be substituted for the device referred to in paragraph (a); and
(c)the device to be added to that list is authorized to be sold by a regulatory agency within its jurisdiction or, if the sale of the device is not required to be authorized by a regulatory agency within its jurisdiction, the device complies with the applicable legal requirements within the agency’s jurisdiction.
note
62.29#
Despite sections 21 and 26, the holder of an establishment licence may import a designated medical device if the following conditions are met:
(a)the holder provides the Minister, in the form and manner specified by the Minister and not later than three business days before the day on which the device is imported, with a notification that contains the following information:
(i)the holder’s name and contact information,
(ii)in respect of the device,
(A)its name and the name of each of its components, parts and accessories, including, if applicable, the model name,
(B)its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family,
(C)the name and contact information of the manufacturer of the device as it appears on the device label,
(D)the name and address of the establishment where it is manufactured, if different from the information referred to in clause (C), and
(E)a detailed description of the medical conditions, purposes and uses for which it is manufactured, sold or represented, as well as its performance specifications if those specifications are necessary for proper use,
(iii)the intended port of entry into Canada,
(iv)the estimated date of arrival of the shipment of the device, and
(v)the total number of units of the device that are intended to be imported on the date referred to in subparagraph (iv);
(b)[Repealed, SOR/2026-96, s. 33] (repealed)
(c)the following information in respect of the device is set out in the List of Medical Devices for Exceptional Importation and Sale:
(i)the device’s name,
(ii)the device’s class,
(iii)the name of the device’s manufacturer,
(iv)the establishment licence number of the holder,
(v)the name of the regulatory agency referred to in paragraph 62.28(c),
(vi)the maximum limit for the total number of units of the device that the holder may import, if applicable, and
(vii)the date after which the device may no longer be imported;
(d)the total number of units of the device that the holder imports does not exceed the maximum limit referred to in subparagraph (c)(vi), if applicable;
(e)the device is imported on or before the date referred to in subparagraph (c)(vii); and
(f)the holder has prepared a plan that specifies the measures to be taken in order for the holder to comply with section 62.32.
note
62.3#
Sections 21.1 and 21.2 do not apply in respect of the importation of a designated medical device under section 62.29.note
62.31#
(1)The provisions of these Regulations — other than this section and sections 44 to 62.2 and 62.32 to 65.6 — do not apply to the sale of a designated medical device that is imported under section 62.29.
(2)Subsection (1) ceases to apply to the sale of a designated medical device on the earlier of
(a)the expiry date of the designated medical device, if the device has one, and
(b)the end of the two-year period that begins on the day that follows the date referred to in subparagraph 62.29(c)(vi).
note
62.311#
(1)No person shall sell a designated medical device that is intended to be sold to the general public on a retail basis unless the information referred to in clause 62.29(a)(ii)(E) is available in English and French to the purchaser or consumer in any of the following manners:
(a)the information accompanies the device;
(b)the information is provided in writing to the purchaser or consumer at the time of sale;
(c)in the case where the device is accessible to the public for self-selection, copies of the information are placed adjacent to the device in a manner that permits the purchaser or consumer to take one.
(2)For the purposes of subsection (1), the English and French versions of the information referred to in clause 62.29(a)(ii)(E) need not be available in the same manner.
note
62.32#
(1)The holder of an establishment licence shall not sell a designated medical device that they imported under section 62.29 unless they ensure that the information referred to in clause 62.29(a)(ii)(E) is available in English and French and in a manner that permits the safe use of the device.
(2)Subject to subsection (3), the holder shall ensure that the information is available in accordance with subsection (1) until at least the latest expiry date of the designated medical devices that they imported.
(3)If the designated medical device does not have an expiry date, the holder shall ensure that the information is available in accordance with subsection (1) until at least the expiration of the period that corresponds to the projected useful life of whichever of the devices that they imported has the latest projected useful life.
note
62.321#
If the holder of an establishment licence receives or becomes aware of the following information in respect of a designated medical device that they imported under section 62.29, the holder shall notify the Minister, in the form and manner specified by the Minister, no later than 72 hours after they receive or become aware of the information, whichever occurs first:
(a)the device is not authorized to be sold by the regulatory agency referred to in paragraph 62.28(d); or
(b)if the sale of the device is not required to be authorized by the regulatory agency referred to in paragraph 62.28(d), the device may not meet the applicable legal requirements within the agency’s jurisdiction.
note
62.322#
(1)Section 61.2 applies — in respect of a designated medical device — to a person who holds an establishment licence and imports the medical device under section 62.29, with any necessary modifications.
(2)A reference to a regulatory agency in paragraphs 61.2(2)(a) to (c) includes a reference to the regulatory agency referred to in paragraph 62.28(c) if that regulatory agency is not set out in the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time.
note
62.323#
A medical device that is removed from the List of Medical Devices for Exceptional Importation and Sale before the date referred to in subsection 62.32(2) or the expiration of the period referred to in subsection 62.32(3), as the case may be, continues to be considered a designated medical device for the purposes of sections 62.32 to 62.322 until that date or the expiration of that period.note
Recalls
Recall Reporting
63#
Sections 63.2, 64 and 65 do not apply to
(a)a retailer; or
(b)a health care facility in respect of a medical device that is distributed for use within that facility.
note
63.1#
Sections 63.2, 64 and 65 do not apply to a manufacturer or importer of a medical device unless the device is likely to cause injury to the health of a patient, user or other person, or could cause serious injury to the health of a patient, user or other person.note
63.2#
A manufacturer or importer of a medical device who decides to recall the device without being ordered to do so by the Minister shall provide the Minister with the following information, in writing, within 24 hours after making the decision:
(a)the name of the device;
(b)the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(c)in the case of a licensed device, the medical device licence number;
(d)in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;
(e)the name and address of
(i)the manufacturer,
(ii)the establishment where the device was manufactured, if different from that of the manufacturer, and
(iii)the importer;
(f)the reason for the recall, the nature of the defectiveness or potential defectiveness of the device and the date on which and the circumstances under which the defectiveness or potential defectiveness was discovered; and
(g)a preliminary evaluation of the risk associated with the defectiveness or potential defectiveness of the device.
note
64#
A manufacturer or importer of a medical device shall, on or before the day on which the manufacturer or importer begins a recall of the device that has not been ordered by the Minister, provide the Minister with the following information and documents in writing:
(a)the name of the device;
(b)the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(c)in the case of a licensed device, the medical device licence number;
(d)in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;
(e)the name and address of
(i)the manufacturer,
(ii)the establishment where the device was manufactured, if different from that of the manufacturer, and
(iii)the importer;
(f)the reason for the recall, the nature of the defectiveness or potential defectiveness of the device and the date on which and the circumstances under which the defectiveness or potential defectiveness was discovered;
(g)an evaluation of the risk associated with the defectiveness or potential defectiveness of the device;
(h)the number of affected units of the device that the manufacturer or importer
(i)manufactured in Canada,
(ii)imported into Canada, and
(iii)sold in Canada;
(i)the period during which the affected units of the device were distributed in Canada by the manufacturer or importer;
(j)the name of each person to whom the affected device was sold by the manufacturer or importer and the number of units of the device sold to each person;
(k)a copy of any communication issued with respect to the recall;
(l)the proposed strategy for conducting the recall, including
(i)the date for beginning the recall,
(ii)the time and manner in which the Minister will be informed of the progress of the recall, and
(iii)the proposed date of its completion;
(m)the proposed action to prevent a recurrence of the problem; and
(n)the name, title and contact information of the representative of the manufacturer or importer to contact for information concerning the recall.
note
65#
A manufacturer or importer of a medical device shall, within 30 days after completing a recall of the device that was not ordered by the Minister, provide the Minister with the following information, in writing:
(a)the results of the recall; and
(b)the action taken to prevent a recurrence of the problem.
note
65.1#
(1)A manufacturer of a medical device who recalls the device without being ordered to do so by the Minister may permit the importer of the device to prepare and submit, on the manufacturer’s behalf, the information and documents that are required to be provided under sections 63.2, 64 and 65 if the information and documents that the manufacturer and importer must submit are identical.
(2)The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to prepare and submit the information and documents referred to in subsection (1) on the manufacturer’s behalf.
note
65.2#
(1)A person who is ordered by the Minister to recall a medical device shall provide the Minister with the following information in the time and manner specified by the Minister:
(a)the name and address of
(i)the manufacturer of the device,
(ii)the establishment where the device was manufactured, if different from that of the manufacturer,
(iii)the importer of the device, and
(iv)the person who sold them the device, if the person who is conducting the recall is not the manufacturer;
(b)the nature of the defectiveness or potential defectiveness of the device and the date on which and the circumstances under which the defectiveness or potential defectiveness was discovered;
(c)the number of affected units of the device that the person
(i)manufactured in Canada,
(ii)imported into Canada, and
(iii)sold in Canada;
(d)the number of affected units of the device in Canada that are in the possession or control of the person;
(e)the period during which the affected units of the device were distributed in Canada by the person;
(f)the number of affected units of the device that have been sold by the person at the retail level to consumers in Canada;
(g)if the person has sold the affected device to persons in Canada other than consumers referred to in paragraph (f), the names of those persons and the number of units of the device sold to each of them;
(h)the proposed strategy for conducting the recall, including
(i)the date for beginning the recall,
(ii)the time and manner in which the Minister will be informed of the progress of the recall, and
(iii)the proposed date of its completion;
(i)the proposed action to prevent a recurrence of the problem;
(k)any other information that the Minister has reasonable grounds to believe is necessary to reduce the risk of injury to health.
(2)The person shall notify the Minister without delay of any change to the information referred to in paragraph (1)(j).
(3)The person shall
(5)The person shall, within 30 days after completing the recall, provide the Minister with the following information in writing:
(a)the results of the recall; and
(b)the action taken to prevent a recurrence of the problem.
note
Record Keeping
65.3#
A manufacturer or importer of a medical device who recalls the device without being ordered to do so by the Minister shall keep a record of the following:
(a)a document that sets out the decision to conduct the recall, including
(i)the name and title of the individual who made the decision, and
(ii)the date the decision was made;
(b)the date the recall was completed;
(c)the information and documents referred to in sections 63.2, 64 and 65; and
(d)the document provided to the Minister under subsection 65.1(2), if applicable.
note
65.4#
(1)Subject to subsection (2), a distributor of a medical device who conducts a recall of the device that was not ordered by the Minister shall keep a record of the following:
(a)the name of the device;
(b)the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(c)in the case of a licensed device, the medical device licence number;
(d)in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;
(e)the name and address of
(i)the manufacturer,
(ii)the establishment where the device was manufactured, if different from that of the manufacturer,
(iii)the importer, and
(iv)the person who sold them the device;
(f)the reason for the recall, the nature of the defectiveness or potential defectiveness of the device and the date on which and circumstances under which the defectiveness or potential defectiveness was discovered;
(g)the number of affected units of the device that the distributor sold in Canada;
(h)the period during which the affected units of the device were distributed in Canada by the distributor;
(j)a copy of any communication issued with respect to the recall;
(k)the results of the recall; and
(l)the date the recall was completed.
(2)A distributor who initiates the recall shall keep a record of the following:
(a)the information and documents referred to in subsection (1);
(b)an evaluation of the risk associated with the defectiveness or potential defectiveness of the medical device to which the recall relates; and
(c)the actions that were proposed and actions taken to prevent a recurrence of the problem.
note
65.5#
A person who is ordered by the Minister to recall a medical device shall keep a record of the information and documents provided to the Minister under section 65.2.note
65.6#
(1)A manufacturer who is required to keep a record under section 65.3 or 65.5 shall keep it for at least the longer of the following periods:
(a)the period that is equivalent to the projected useful life of the medical device to which the recall relates plus two years; and
(b)the period during which the device is sold in Canada.
(3)For the purpose of paragraph (1)(a) and subsection (2), the retention period begins on the day on which the recall is completed.
note
Implant Registration
66#
(1)Subject to section 68, the manufacturer of an implant shall provide, with the implant, two implant registration cards that contain
(a)the name and address of the manufacturer;
(b)the name and address of any person designated by the manufacturer for the collection of implant registration information;
(c)a notice advising the patient that the purpose of the cards is to enable the manufacturer to notify the patient of new information concerning the safety, effectiveness or performance of the implant, and any required corrective action; and
(d)a statement advising the patient to notify the manufacturer of any change of address.
(2)An implant registration card shall be designed for the recording of the following information:
(a)the name of the device, its control number and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(b)the name and address of the health care professional who carried out the implant procedure;
(c)the date on which the device was implanted;
(d)the name and address of the health care facility at which the implant procedure took place; and
(e)the patient’s name and address or the identification number used by the health care facility to identify the patient.
(3)The two implant registration cards referred to in subsection (1) shall be printed in both official languages; however, the manufacturer may choose to provide four cards, two in English and two in French.
67#
(1)Subject to subsection (2), a member of the staff of the health care facility where an implant procedure takes place shall, as soon as possible after the completion of the procedure, enter the information required by subsection 66(2) on each implant registration card, give one card to the implant patient and forward one card to the manufacturer of the implant or the person designated pursuant to paragraph 66(1)(b).
(2)The patient’s name and address shall not be entered on the implant registration card forwarded to the manufacturer or person designated pursuant to paragraph 66(1)(b) except with the patient’s written consent.
(3)The health care facility, the manufacturer or the person designated pursuant to paragraph 66(1)(b) shall not disclose the patient’s name or address, or any information that might identify the patient, unless the disclosure is required by law.
note
68#
(1)The manufacturer of an implant may apply in writing to the Minister for authorization to use an implant registration method other than the implant registration cards described in section 66.
(2)The Minister shall authorize the use of the implant registration method proposed in the application referred to in subsection (1) if the Minister determines that the method will enable the manufacturer to achieve the purpose set out in paragraph 66(1)(c) as effectively as the use of implant registration cards.
(3)Where an authorization has been granted pursuant to subsection (2), the manufacturer shall implement the alternative implant registration method, and sections 66 and 67 shall apply with such modifications as are necessary.
note
Part 1.1 · Medical Devices for an Urgent Public Health Need
Definitions and Interpretation
68.01#
The following definitions apply in this Part.
COVID-19 [Repealed, SOR/2023-277, s. 3]
COVID-19 medical device [Repealed, SOR/2023-277, s. 3]
List of Medical Devices for an Urgent Public Health Need means the List of Medical Devices for an Urgent Public Health Need that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux pour des besoins urgents en matière de santé publique)
List of Medical Devices for Expanded Use means the List of Medical Devices for Expanded Use that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux destinés à un usage élargi)
UPHN medical device means any of the following medical devices for an urgent public health need:
(a)a medical device that is set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1;
(b)a medical device that belongs to a category of medical devices that is set out in column 2 of Part 2 of that list and that is manufactured, sold or represented for use in relation to the corresponding medical condition that is set out in column 1. (instrument médical BUSP)
note
68.011#
For the purposes of paragraphs 68.21(1)(h), (i) and (j), and sections 68.24, 68.3, 68.31 and 68.34, a medical device for which the manufacturer holds an authorization is considered not to be a UPHN medical device if
(a)the device is not set out in column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need and does not belong to a category of medical devices that is set out in column 2 of Part 2 of that list; or
(b)the device is set out in column 2 of Part 1 of that list or belongs to a category of medical devices that is set out in column 2 of Part 2 of that list but is not authorized in relation to a corresponding medical condition that is set out, as the case may be, in column 1 of Part 1 or column 1 of Part 2.
note
Application
Authorization
Non-application of Part 1 — Importation and Sale
68.03#
(1)Despite section 8, Part 1 does not apply in respect of the importation or sale of a medical device if the manufacturer holds an authorization for the device.
(2)However, the following provisions of Part 1 apply in respect of the importation or sale of the medical device:
(a)in the case of an importer, sections 59 to 61;
(b)in the case of an importer or distributor, sections 44 to 51.1; and
(c)sections 21, 23, 27, 52 to 58, 62 and 62.21 to 65.6.
(3)Despite paragraph (2)(b), subsection 44(3) does not apply if the medical device that is imported is a Class I device and the person from whom the device is imported is the manufacturer.
note
Advertising — Authorized Class I Medical Device
68.031#
No person shall advertise for the purpose of sale a Class I medical device for which the manufacturer holds an authorization if the device has been subjected to a change described in section 68.13 unless
(a)the manufacturer holds an amended authorization; or
(b)the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been authorized in accordance with Canadian law.
note
Deemed Authorization
68.05#
In sections 68.06 to 68.09, authorized, in relation to a medical device, means that the device is the subject of an authorization.note
68.06#
If a system is authorized, all of its components or parts that are manufactured by the manufacturer of the system are deemed, for the purposes of its importation, sale or advertisement, to be authorized.note
68.07#
If a test kit is authorized, all of its reagents or articles that are manufactured by the manufacturer of the test kit are deemed, for the purposes of its importation, sale or advertisement, to be authorized.note
68.08#
If a medical device or medical device group is authorized and forms part of a medical device family or medical device group family, as the case may be, all other medical devices or medical device groups in the family are deemed to be authorized.note
68.09#
(1)If all the medical devices that form part of a medical device group are authorized, that medical device group is deemed to be authorized.
(2)If a medical device group is authorized, all the medical devices that form part of the medical device group are deemed, for the purposes of its importation, sale or advertisement, to be authorized.
note
Application for an Authorization
68.1#
(1)The Minister may add a medical condition to column 1 of Part 1 or Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that
(a)the medical condition presents, or is the result of, a significant risk to public health in Canada; and
(b)immediate action is required to deal with the risk.
(2)The Minister may add a medical device to column 2 of Part 1 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need for the device that is related to the corresponding medical condition that is set out in column 1.
(3)The Minister may add a category of medical devices to column 2 of Part 2 of the List of Medical Devices for an Urgent Public Health Need only if the Minister has reasonable grounds to believe that there is an urgent public health need for the devices that belong to that category that is related to the corresponding medical condition set out in column 1.
note
68.11#
(1)A manufacturer of a medical device may submit to the Minister an application for an authorization for the device if it is a UPHN medical device.
(2)The application shall be submitted in a form established by the Minister. The application shall contain sufficient information and documents to enable the Minister to determine whether to issue the authorization, including
(a)the name of the device;
(b)the class of the device;
(c)the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(d)the name and address of the manufacturer as it appears on the device label;
(e)the name and address of the establishment where the device is manufactured, if different from those referred to in paragraph (d);
(f)a description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented;
(g)information respecting the safety and effectiveness of the device;
(h)evidence that establishes that the manufacturer has a quality management system in place in respect of the device;
(i)the directions for use, unless directions are not required for the device to be used safely and effectively;
(j)an attestation by the manufacturer that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls; and
(k)a copy of the device label.
(3)An application in respect of a Class III or IV medical device shall contain, in addition to the information and documents referred to in subsection (2),
(a)a description of the materials used in the manufacture and packaging of the device; and
(b)a list of the countries, other than Canada, where the device has been sold, the total number of units sold in those countries and a summary of any reported problems with the device and any recalls of the device in those countries.
(4)Despite subsection (2) and subsection (3), the application need not include the information and documents referred to in paragraphs (2)(g) and (h) and, if applicable, subsection (3) if
(a)the application includes information that demonstrates that an authorization or licence for sale of the medical device has been issued by a regulatory agency and that the authorization or licence has not been suspended or revoked; and
(b)the name of the regulatory agency appears in the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time.
note
Issuance
68.12#
The Minister shall issue an authorization for a medical device if the following requirements are met:
(a)the manufacturer has submitted an application to the Minister that meets the requirements set out in section 68.11;
(b)[Repealed, SOR/2023-277, s. 10] (repealed)
(c)the Minister has sufficient evidence to support the conclusion that the benefits associated with the device outweigh the risks associated with it, having regard to
(i)the uncertainties relating to those benefits and risks, and
(ii)the urgent public health need for the device or the absence of any such need;
(d)the Minister has sufficient evidence to support the conclusion that the manufacturer has a quality management system in place that is adequate to
(i)control the quality and, if applicable, the purity and sterility of the device and the materials used in the manufacture of the device, and
(ii)ensure that the device meets the specifications of the device; and
(e)the Minister determines that the health or safety of patients, users or other persons will not be unduly affected by the device.
note
Amendment
68.13#
No person shall import or sell a medical device for which the manufacturer holds an authorization if the device has been the subject of any of the following changes unless the manufacturer holds an amended authorization:
(a)in the case of a Class III or IV device, a significant change;
(b)a change that would result in a change of the class of the device;
(c)a change in the name of the manufacturer;
(d)a change in the name of the device;
(e)a change in the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(f)in the case of a Class I or II device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.
note
68.14#
An application to amend an authorization shall be submitted to the Minister by the holder of the authorization in a form established by the Minister. The application shall contain sufficient information and documents to enable the Minister to determine whether to amend the authorization, including the information and documents referred to in subsection 68.11(2) and (3) that relate to the change referred to in section 68.13 for which an amendment to the authorization is required.note
68.15#
The Minister shall amend an authorization for a medical device if the following requirements are met:
(a)the holder of the authorization has submitted an application to the Minister that meets the requirements set out in section 68.14;
(b)the Minister has sufficient evidence to support the conclusion that the benefits associated with the device outweigh the risks associated with it, having regard to
(i)the uncertainties relating to those benefits and risks, and
(ii)the urgent public health need for the device or the absence of any such need; and
(c)the Minister determines that the health or safety of patients, users or other persons will not be unduly affected by the device.
note
Refusal
68.16#
The Minister may refuse to issue or amend an authorization for a medical device if
(a)the Minister has reasonable grounds to believe that the manufacturer has contravened these Regulations or any provision of the Act relating to medical devices;
(b)the Minister has reasonable grounds to believe that the device is not labelled in accordance with sections 21 and 23; or
(c)the manufacturer has not submitted to the Minister all information, documents or material that was requested under section 68.23 to enable the Minister to determine whether to issue or amend the authorization, within the time limit specified in the request.
note
68.17#
The Minister shall refuse to amend an authorization for a medical device if the effect of the proposed amendment would be that the device would not be authorized in relation to at least one of the following medical conditions:
(a)a medical condition that qualified the device as a UPHN medical device when the application for the authorization was submitted under section 68.11;
(b)a medical condition in relation to which the device was authorized when the application to amend the authorization was submitted under section 68.14, in the case where
(i)the holder of the authorization previously submitted an application to amend the authorization under section 68.14 to have the device authorized in relation to the medical condition,
(ii)the medical condition qualified the device as a UPHN medical device when that previous application was submitted, and
(iii)the authorization was amended under section 68.15 on the basis of that previous application;
(c)a medical condition in relation to which the device was not authorized when the application to amend the authorization was submitted under section 68.14, in the case where
(i)the holder of the authorization submitted the application to have the device authorized in relation to the medical condition, and
(ii)the medical condition qualified the device as a UPHN medical device when the application was submitted.
note
68.18#
If the Minister refuses to issue or amend an authorization, the Minister shall notify the manufacturer of the medical device in writing of the reasons for the refusal and give them an opportunity to be heard.note
Terms and Conditions
68.19#
The Minister may, at any time, impose terms and conditions on an authorization for a medical device or amend those terms and conditions.note
Applications Submitted Under Part 1
68.2#
Despite section 68.03, the holder of an authorization for a medical device may submit
(a)in the case of a Class I device, an application under section 45 for an establishment licence that would authorize the holder to sell or import the device; or
(b)in the case of a Class II, III or IV device, an application under section 32 for a licence for the device.
note
Cancellation
68.21#
(1)The Minister may cancel an authorization for a medical device by written notice to the holder, giving reasons, if
(a)the Minister has reasonable grounds to believe that the holder has contravened these Regulations or any provision of the Act relating to medical devices;
(b)the Minister has reasonable grounds to believe that the risks associated with the device outweigh the benefits associated with it, having regard to
(i)the uncertainties relating to those benefits and risks, and
(ii)the urgent public health need for the device or the absence of any such need;
(c)the Minister has reasonable grounds to believe that the holder does not have a quality management system in place that is adequate to
(i)control the quality and, if applicable, the purity and sterility of the device and the materials used in the manufacture of the device, and
(ii)ensure that the device meets the specifications of the device;
(d)the Minister has reasonable grounds to believe that the health or safety of patients, users or other persons may be unduly affected by the device;
(e)the Minister has reasonable grounds to believe that the holder has failed to comply with the terms and conditions of the authorization;
(f)in the case of an authorization issued in respect of an application submitted on the basis of subsection 68.11(4), the Minister becomes aware that the authorization or licence for sale of the device that had been issued by the regulatory agency is suspended or revoked;
(g)the holder has not submitted to the Minister all information, documents or material that was requested under section 68.23 to enable the Minister to determine whether to cancel the authorization, within the time limit specified in the request;
(h)in the case of a Class I device that is not a UPHN medical device,
(i)the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, submit an application under section 45 for an establishment licence that would authorize the holder to sell or import the device,
(ii)the Minister refuses to issue an establishment licence to the holder under section 47, or
(iii)the holder withdraws the application referred to in subparagraph (i);
(i)in the case of a Class II device that is not a UPHN medical device,
(i)the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of a contract, signed by both the holder and a registrar recognized by the Minister under section 32.1, that meets the following conditions:
(A)the contract indicates that the holder has begun the certification process to determine whether they have a quality management system that satisfies the standard referred to in paragraph 32(2)(f), and
(B)the contract is in effect when that period expires, or
(ii)the holder does not, within two years after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f); or
(j)in the case of a Class III or IV device that is not a UPHN medical device,
(i)the holder does not, within 120 days after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of a contract, signed by both the holder and a registrar recognized by the Minister under section 32.1, that meets the following conditions:
(A)the contract indicates that the holder has begun the certification process to determine whether they have a quality management system that satisfies the standard referred to in paragraph 32(3)(j) or (4)(p), as the case may be, and
(B)the contract is in effect when that period expires, or
(ii)the holder does not, within two years after the day on which the device ceases to be a UPHN medical device, provide the Minister with a copy of the quality management system certificate referred to in paragraph 32(3)(j) or (4)(p), as the case may be.
(1.1)If a medical device ceases to be a UPHN medical device after an application for an authorization is submitted under section 68.11 but before the Minister issues the authorization under section 68.12, the reference to “the device ceases to be a UPHN medical device” in subparagraph (1)(h)(i), (i)(i) or (j)(i), as the case may be, shall be read as “the Minister issued the authorization”.
(1.2)Subsection (1.1) ceases to apply in respect of the medical device if the device is authorized in relation to a medical condition that qualifies it as a UPHN medical device.
(2)A ground for cancellation specified in subparagraph (1)(i)(i) or (j)(i) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be, or a copy of the contract referred to in the applicable subparagraph.
(3)A ground for cancellation specified in subparagraph (1)(i)(ii) or (j)(ii) does not apply if the holder has already provided the Minister with a copy of the quality management system certificate referred to in paragraph 32(2)(f), (3)(j) or (4)(p), as the case may be.
note
68.22#
An authorization for a medical device is cancelled if
(a)in the case of a Class I device, the holder of the authorization is issued an establishment licence under section 46 that authorizes the holder to sell or import the device;
(b)in the case of a Class II, III or IV device, the holder of the authorization is issued a licence for the device under section 36; or
(c)the holder of the authorization informs the Minister under section 68.25 that the holder has discontinued the sale of the device in Canada.
note
Additional Information and Material
68.23#
The Minister may request that the manufacturer of a medical device who has submitted an application for an authorization or the holder of an authorization submit to the Minister, within a specified time limit, any additional information or documents or any material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or cancel the authorization.note
Annual Review
68.24#
The holder of an authorization for a Class II, III or IV medical device that is not a UPHN medical device shall, annually before November 1 and in a form established by the Minister, provide the Minister with a statement signed by the holder or a person authorized to sign on the holder’s behalf
(a)confirming that all the information and documents submitted by the holder with respect to the device are still correct; or
(b)describing any change to the information and documents submitted by the holder with respect to the device, other than those to be submitted under section 68.14 or 68.34.
note
Notification — Suspension or Revocation
68.241#
(1)This section applies to the holder of an authorization for a medical device that was issued in respect of an application submitted on the basis of subsection 68.11(4).
(2)If the holder of an authorization for a medical device receives or becomes aware of information to the effect that the authorization or licence for sale of the device that was issued by the regulatory agency is suspended or revoked, the holder shall notify the Minister within 72 hours after they receive or become aware of the information, whichever occurs first.
(3)However, the holder is not required to notify the Minister if they or the holder referred to in paragraph 68.3(1)(b) submits that information under section 68.3.
note
Discontinuation of Sale
68.25#
If the holder of an authorization for a medical device discontinues the sale of the device in Canada, the holder shall inform the Minister within 30 days after the discontinuation.note
Importation — Copy of Authorization
68.26#
If the manufacturer of a medical device holds an authorization for the device, the importer of a shipment of the device shall ensure that the shipment is accompanied by a copy of the authorization.note
Incident Reporting
68.27#
(1)The holder of an authorization for a medical device shall submit a preliminary report to the Minister in respect of any incident that comes to their attention occurring in Canada that involves the device
(a)within 10 days after becoming aware of the incident, if the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person; or
(b)within 30 days after becoming aware of the incident, if the incident has not led to the death or a serious deterioration in the state of health of a patient, user or other person but could do so were it to recur.
(2)The preliminary report shall contain the following information:
(a)the name of the medical device and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(b)the names and addresses of the holder and of any known importer of the medical device as well as the name, title and contact information of a representative of the holder to contact for any information concerning the incident;
(c)the date on which the holder became aware of the incident;
(d)the details known in respect of the incident, including the date on which the incident occurred and the consequences for the patient, user or other person;
(e)the name and contact information, if known, of the person who reported the incident to the holder;
(f)the names of any other medical devices involved in the incident, including any accessories, if known;
(g)the preliminary comments of the holder with respect to the incident;
(h)the course of action, including an investigation, that the holder proposes to follow in respect of the incident and a timetable for carrying out any proposed action and submitting a final report; and
(i)a statement indicating whether a previous report has been made to the Minister with respect to the medical device and, if so, the date of the report.
note
68.28#
(1)The holder of the authorization shall, after making the preliminary report, submit a final report to the Minister in accordance with the timetable established under paragraph 68.27(2)(h).
(2)The final report shall contain the following information:
(a)a description of the incident, including the number of persons who have died or experienced a serious deterioration in the state of their health;
(b)a detailed explanation of the cause of the incident and a justification for the actions taken in respect of the incident; and
(c)any actions taken in respect of the medical device as a result of the investigation referred to in paragraph 68.27(2)(h), which may include
(i)increased post-market surveillance of the device,
(ii)corrective and preventive action respecting the design and manufacture of the device, and
(iii)recall of the device.
note
68.29#
The holder of the authorization is not required to submit the preliminary report referred to in section 68.27 or the final report referred to in section 68.28 if
(a)the information that the holder would be required to include in that preliminary report is identical to the information that the importer of the device is required to include in the preliminary report referred to in subsection 59(1);
(b)the information that the holder would be required to include in that final report is identical to the information that the importer of the device is required to include in the final report referred to in subsection 59(1); and
(c)the holder advises the Minister in writing that the importer of the device is submitting the preliminary report and the final report under subsection 59(1).
note
Serious Risk of Injury to Human Health
68.3#
(1)This section applies to the following holders of therapeutic product authorizations:
(a)a holder of an authorization for a Class II, III or IV medical device that is not a UPHN medical device; and
(b)a holder of an establishment licence to import Class II, III or IV medical devices that imports a device referred to in paragraph (a).
(2)The holder of a therapeutic product authorization shall submit to the Minister information in respect of any serious risk of injury to human health that the holder receives or becomes aware of and that is relevant to the safety of a device referred to in paragraph (1)(a), regarding
(a)risks that have been communicated by any regulatory agency that is set out in the List of Regulatory Agencies for the Purposes of Sections 61.2 and 68.3 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a medical device within the jurisdiction of such a regulatory agency, and the manner of the communication;
(b)changes that have been made to the labelling of any medical device and that have been communicated to or requested by any regulatory agency that is set out in that list; and
(c)recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of any medical device, that have taken place within the jurisdiction of any regulatory agency that is set out in that list.
(3)The information shall be submitted to the Minister within 72 hours after the holder receives or becomes aware of it, whichever occurs first.
note
68.301#
(1)Despite subsection 68.3(2), if the holder of a therapeutic product authorization issued in respect of a medical device is the manufacturer, they may permit the importer of the device to submit the information required under that subsection on the manufacturer’s behalf if the information that the manufacturer and the importer must submit is identical.
(2)The manufacturer shall advise the Minister in writing if the manufacturer has permitted the importer to submit the information on the manufacturer’s behalf.
note
Summary Report
68.31#
(1)The holder of an authorization for a Class II, III or IV medical device that is not a UPHN medical device shall prepare
(a)in the case of a Class II device, on a biennial basis, a summary report of the information referred to in subsection (2) that the holder received or became aware of during the previous 24 months; and
(b)in the case of a Class III or IV device, on an annual basis, a summary report of the information referred to in subsection (2) that the holder received or became aware of during the previous 12 months.
(2)The information to be covered by the summary report is that in respect of
(a)adverse effects;
(b)problems referred to in paragraph 57(1)(a);
(c)incidents referred to in subsection 68.27(1); and
(d)serious risks of injury to human health that are relevant to the safety of the medical device and are referred to in subsection 68.3(1).
(3)The summary report shall contain a concise critical analysis of the information referred to in subsection (2).
(4)In preparing the summary report, the holder shall determine, on the basis of the critical analysis, whether what is known about the benefits and risks associated with the medical device has changed in any of the following ways:
(a)the potential benefits for patients through the use of the device may be less;
(b)in respect of each of the risks,
(i)the harm associated with the risk is more likely to occur, or
(ii)if the harm associated with the risk occurs, the consequences for the health or safety of patients, users or other persons could be more serious; and
(c)a new risk has been identified.
(5)The holder shall include the conclusions they reach under subsection (4) in the summary report.
(6)If, in preparing the summary report, the holder concludes that what is known about the benefits and risks associated with the medical device has changed in any of the ways referred to in paragraphs (4)(a) to (c), they shall notify the Minister, in writing, within 72 hours after having reached the conclusion, unless that has already been done.
note
68.32#
(1)The Minister may, for the purposes of determining whether there is sufficient evidence to support the conclusion that the benefits associated with a medical device outweigh the risks, request that the holder of an authorization for the device submit, within a specified time limit, any of the following:
(a)summary reports; or
(b)information on the basis of which summary reports were prepared.
(2)The holder shall submit to the Minister the summary reports or information, or both, that the Minister requests within the time limit specified in the request.
note
68.33#
(1)The holder of an authorization for a medical device shall maintain records of the summary reports and the information on the basis of which those reports were prepared.
(2)The holder shall retain the records for seven years after the day on which they were created.
note
Obligation to Submit Certificate
68.34#
(1)If a new or modified quality management system certificate is issued in respect of a medical device for which the manufacturer holds an authorization and that is not a UPHN medical device, the manufacturer shall submit a copy of the certificate to the Minister within 30 days after it is issued.
(2)Subsection (1) does not apply if the manufacturer includes the new or modified quality management system certificate in an application to amend the authorization that is submitted under section 68.14.
note
Sale — Cancellation of Authorization
68.35#
Subject to sections 21, 23 and 44, if an authorization for a medical device is cancelled under paragraph 68.21(1)(h), (i) or (j), a person other than the manufacturer may sell the device, despite any other provision in Part 1, for a period of six months beginning on the day on which the authorization is cancelled.note
Expanded Use
68.351#
The Minister may add a medical condition to column 1 of the List of Medical Devices for Expanded Use only if the Minister has reasonable grounds to believe that
(a)the medical condition presents, or is the result of, a significant risk to public health in Canada; and
(b)immediate action is required to deal with the risk.
note
68.36#
(1)The Minister may add a licensed medical device, or a Class II, III or IV medical device for which the manufacturer holds an authorization, to column 2 of the List of Medical Devices for Expanded Use and an expanded use to column 3 only if the following conditions are met:
(a)the Minister has reasonable grounds to believe that there is an urgent public health need for the expanded use of the device that is related to the corresponding medical condition that is set out in column 1;
(b)the Minister has sufficient evidence to support the conclusion that the benefits associated with the expanded use outweigh the risks associated with it, having regard to
(i)the uncertainties relating to those benefits and risks, and
(ii)the urgent public health need for the device; and
(c)the Minister determines that the health or safety of patients, users or other persons will not be unduly affected by the expanded use of the device.
(2)In the case of a licensed medical device, sections 26 and 27, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if
(a)the medical condition to which the expanded use relates is set out in column 1 of the List of Medical Devices for Expanded Use;
(b)the device is set out in column 2 of that list; and
(c)the expanded use of the device is set out in column 3 of that list.
(3)In the case of a Class II, III or IV medical device for which the manufacturer holds an authorization, sections 27 and 68.13, as they relate to an expanded use of the device, do not apply in respect of the importation, sale or advertisement of the device if
(a)the medical condition to which the expanded use relates is set out in column 1 of the List of Medical Devices for Expanded Use;
(b)the device is set out in column 2 of that list; and
(c)the expanded use of the device is set out in column 3 of that list.
note
68.37#
The Minister shall publish on the Government of Canada website supplementary information pertaining to the expanded use, set out in column 3 of the List of Medical Devices for Expanded Use, of a licensed medical device — or a Class II, III or IV medical device for which the manufacturer holds an authorization —, set out in column 2 of that list, including
(a)a statement of the expanded use;
(b)a statement of the known and potential benefits and risks; and
(c)any supplement to the directions for use, unless a supplement is not required for the device to be used safely and effectively.
note
68.38#
(1)The Minister may request from the holder of a medical device licence, in respect of the medical device that is set out in column 2 of the List of Medical Devices for Expanded Use for which the licence was issued, any information in relation to the expanded use that is set out in column 3 of that list that the holder possesses or to which they have reasonable access.
(2)The Minister may request from the holder of an authorization, in respect of the Class II, III or IV medical device set out in column 2 of the List of Medical Devices for Expanded Use for which the authorization was issued, any information in relation to the expanded use set out in column 3 of that list that the holder possesses or to which they have reasonable access.
(3)The holder of the licence or authorization shall submit to the Minister the information that the Minister requests within the time limit specified in the request.
note
Part 2 · Custom-Made Devices and Medical Devices to Be Imported or Sold for Special Access
Application
69#
(1)This Part applies to custom-made devices and medical devices that are to be imported or sold for special access.
(2)In this Part, special access means access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable.
General
70#
No person shall import or sell a Class III or IV custom-made device or a medical device for special access unless the Minister has issued an authorization for its sale or importation.
Authorization
71#
(1)If a health care professional wishes to obtain a medical device referred to in section 70, the professional shall apply to the Minister for an authorization that would permit the manufacturer or importer of the device to sell, or to import and sell, the device to that professional.
(2)The application shall contain the following:
(a)the name of the device, its class and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(b)the number of units required;
(c)the name and address of the manufacturer or importer;
(d)the name, title and telephone number of the representative of the manufacturer or importer to contact for any information concerning the device;
(e)the diagnosis, treatment or prevention for which the device is required;
(f)a statement that sets out
(i)the reasons the device was chosen for the diagnosis, treatment or prevention,
(ii)the risks and benefits that are associated with its use, and
(iii)the reasons the diagnosis, treatment or prevention could not be accomplished using
(A)a licensed medical device that is available for sale in Canada, or
(B)a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and that is available for sale in Canada;
(g)the name and address of each health care facility at which the device is to be used by that professional;
(h)the known safety and effectiveness information in respect of the device;
(i)a written undertaking by the health care professional that the professional will inform the patient for whom the device is intended of the risks and benefits associated with its use;
(j)the directions for use, unless directions are not required for the device to be used safely and effectively; and
(k)in the case of a custom-made device, a copy of the health care professional’s written direction to the manufacturer giving the design characteristics of the device.
72#
(1)The Minister shall issue an authorization referred to in subsection 71(1) to a manufacturer or importer if the Minister determines that
(a)the benefits that may be obtained by the patient through the use of the device outweigh the risks associated with its use;
(b)the health or safety of patients, users or other persons will not be unduly affected;
(c)a licensed device that would adequately meet the requirements of the patient is not available in Canada;
(c.1)a medical device for which the manufacturer of that device holds an authorization issued under section 68.12 and that would adequately meet the requirements of the patient is not available for sale in Canada; and
(d)the authorization is not being used by the manufacturer or importer to circumvent the requirements of Part 1 or 1.1.
(2)The authorization issued under subsection (1) shall specify
(a)the number of units of the device authorized to be imported;
(b)the number of units of the device authorized to be sold; and
(c)the name of the health care professional to whom the manufacturer or importer may sell the device.
Additional Information
73#
If the information and documents submitted in respect of an application made pursuant to section 71 are insufficient to enable the Minister to determine whether the conditions set out in subsection 72(1) have been met, the manufacturer, importer or health care professional shall, at the request of the Minister, submit any further information relevant to the application that the Minister may request.
74#
The Minister may, in respect of an authorization that has been issued,
(a)request the manufacturer, importer or health care professional to submit information in respect of the device if the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that the device for which the authorization has been issued no longer meets the conditions set out in subsection 72(1); and
(b)issue a written cancellation of the authorization, giving reasons, if
(i)the Minister determines that the conditions set out in subsection 72(1) are no longer met, or
(ii)the information referred to in paragraph (a) has not been submitted.
Labelling
75#
No person shall import or sell a medical device in respect of which an authorization has been issued pursuant to section 72, or a Class I or II custom-made device, unless the device has a label that
(a)sets out the name of the manufacturer;
(b)sets out the name of the device; and
(c)specifies whether the device is a custom-made device or is being imported or sold for special access.
Distribution Records
76#
The manufacturer or importer of a medical device in respect of which an authorization has been issued pursuant to section 72 shall maintain a distribution record in respect of the device in accordance with sections 52 to 56.
Incident Reporting
77#
The health care professional referred to in subsection 71(1) shall, within 72 hours after becoming aware of an incident that involves the medical device for which an authorization has been issued under section 72 and that meets the following conditions, report the incident to the Minister and to the manufacturer or importer of the device and specify the nature of the incident and the circumstances surrounding it:
(a)the incident is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use; and
(b)the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person or could do so were the incident to recur.
note
Implant Registration
Part 3 · Medical Devices for Investigational Testing Involving Human Subjects
Application
General
80#
(1)Subject to subsections (2) and (3), no person shall import or sell a medical device for investigational testing.
(2)A manufacturer or importer of a Class II, III or IV medical device may sell the device to a qualified investigator for the purpose of conducting investigational testing if the manufacturer or importer holds an authorization issued under subsection 83(1) and possesses records that contain all the information and documents required by section 81.
(3)A manufacturer or importer of a Class I medical device may sell the device to a qualified investigator for the purpose of conducting investigational testing if the manufacturer or importer possesses records that contain all the information and documents required by section 81.
Records
81#
The records referred to in section 80 shall contain the following:
(a)the name, address and telephone number of the manufacturer and the importer of the device;
(b)the name of the device, its class and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
(c)a description of the device and of the materials used in its manufacture and packaging;
(d)a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented;
(e)a list of the countries other than Canada where the device has been sold, the total number of units sold in those countries, and a summary of any reported problems with the device and any recalls of the device in those countries;
(f)a risk assessment comprising an analysis and evaluation of the risks, and the risk reduction measures adopted for the purposes of conducting investigational testing of the device, including, as appropriate,
(i)the results of any previous research, testing and studies conducted with respect to the device,
(ii)a description of the methods currently used to diagnose or treat the medical condition in respect of which the investigational testing is being proposed, and
(iii)information respecting any cautions, warnings, contra-indications and possible adverse effects associated with the use of the device;
(g)the names of all the qualified investigators to whom the device is proposed to be sold and their qualifications, including their training and experience;
(h)the name and address of each institution at which the investigational testing is proposed to be conducted and, in the case of a Class III or IV device, written approval from the institution indicating that the investigational testing may be carried out there;
(i)a protocol of the proposed investigational testing, including the number of units of the device proposed to be used for the testing, the hypothesis for and objective of the testing, the period of time during which the testing will be carried out and a copy of the patient consent form;
(j)a copy of the device label; and
(k)a written undertaking from each qualified investigator to
(i)conduct the investigational testing in accordance with the protocol provided by the manufacturer,
(ii)inform a patient who is to be diagnosed or treated using the device of any risks and benefits associated with its use, and obtain the patient’s written consent for its use,
(iii)not use the device or permit it to be used for any purpose other than the investigational testing specified in the protocol,
(iv)not permit the device to be used by any other person except under the direction of the qualified investigator, and
(v)in the event of an incident involving the device and that meets the following conditions, report the incident and the circumstances surrounding it to the Minister and to the manufacturer or importer of the device within 72 hours after the qualified investigator becomes aware of the incident:
(A)the incident is related to a failure of the device or a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use, and
(B)the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person or could do so were the incident to recur.
note
Authorization
82#
An application for an authorization referred to in subsection 80(2) shall be made in writing to the Minister and shall contain
(a)in the case of a Class II medical device or a Class III or IV in vitro diagnostic device that is not used for patient management, not including a near-patient in vitro diagnostic device, the information set out in paragraphs 81(a), (b) and (h) to (j); and
(b)in the case of a Class III or IV medical device that is not covered by paragraph (a), the information and documents set out in section 81.
note
83#
(1)The Minister shall issue an authorization referred to in subsection 80(2) to a manufacturer or importer if the Minister determines that
(a)the device can be used for investigational testing without seriously endangering the life, health or safety of patients, users or other persons;
(b)the investigational testing is not contrary to the best interests of patients on whom the testing will be conducted; and
(c)the objective of the testing will be achieved.
(2)The authorization referred to subsection (1) shall specify
(a)the name of any qualified investigator to whom the device may be sold;
(b)the type of diagnosis or treatment for which the device may be sold;
(c)the number of units of the device that are authorized to be sold; and
(d)the protocol according to which the investigational testing is to be conducted.
note
Additional Information
84#
If the information and documents submitted in respect of an application made pursuant to section 82 are insufficient to enable the Minister to determine whether the conditions set out in subsection 83(1) have been met, the manufacturer or importer shall, at the request of the Minister, submit any further information relevant to the application that the Minister may request.
85#
(1)The Minister may, in respect of a medical device in relation to which investigational testing is being conducted, request the manufacturer or importer of the device to submit information in respect of the testing if the Minister believes on reasonable grounds, after reviewing a report or information brought to the Minister’s attention, that one of the following conditions may exist:
(a)the testing seriously endangers the life, health or safety of patients, users or other persons;
(b)the testing is contrary to the best interests of patients on whom the testing is being conducted;
(c)the objective of the testing will not be achieved;
(d)the qualified investigator who is conducting the testing is not respecting the undertaking required by paragraph 81(k); or
(e)the information submitted in respect of the testing is false or misleading.
(2)If the information requested pursuant to subsection (1) is not submitted, or if it is submitted and the Minister determines after reviewing it that a condition identified in that subsection exists, the Minister may, by written notice giving reasons,
(a)in the case of a Class I device, direct the manufacturer or importer of the device to stop selling the device to any qualified investigator named in the notice; or
(b)in the case of a Class II, III or IV device, cancel the authorization referred to in subsection 83(1), in whole or in part.
Labelling
86#
No person shall import or sell a medical device for investigational testing unless the device has a label that sets out
(a)the name of the manufacturer;
(b)the name of the device;
(c)the statements “Investigational Device” and “Instrument de recherche”, or any other statement, in English and French, that conveys that meaning;
(d)the statements “To Be Used by Qualified Investigators Only” and “Réservé uniquement à l’usage de chercheurs compétents”, or any other statement, in English and French, that conveys that meaning; and
(e)in the case of an IVDD, the statements “The performance specifications of this device have not been established” and “Les spécifications de rendement de l’instrument n’ont pas été établies”, or any other statement, in English and French, that conveys that meaning.
Advertising
87#
No person shall advertise a medical device that is the subject of investigational testing unless
(a)that person holds an authorization issued under subsection 83(1) to sell or import the device; and
(b)the advertisement clearly indicates that the device is the subject of investigational testing, and the purpose of the investigational testing.
Other Requirements
88#
The requirements set out in the following provisions apply to medical devices to which this Part applies:
(a)sections 52 to 56 with respect to distribution records;
(b)sections 57 and 58 with respect to complaint handling;
(c)sections 59 to 61.1 with respect to reports on incidents;
(d)sections 63 to 65.6 with respect to recalls; and
(e)sections 66 to 68 with respect to implant registration.
note
88.1#
Subsections 61.2(2) and (3) and section 61.3 apply in respect of medical devices to which this Part applies except that the references to a holder of a therapeutic product authorization in those provisions shall be read as references to a holder of an authorization issued under subsection 83(1).note
Part 4 · Export Certificates
89#
(1)For the purposes of section 37 of the Act, Schedule 3 sets out the form to be used for an export certificate for medical devices.
(2)The export certificate shall be signed and dated by
(a)where the exporter of the device is a corporation,
(i)the exporter’s senior executive officer in Canada,
(ii)the exporter’s senior regulatory officer in Canada, or
(iii)the authorized agent of the person referred to in subparagraph (i) or (ii); or
(b)where the exporter of the device is an individual,
(i)the exporter, or
(ii)the exporter’s authorized agent.
90#
No person shall sign an export certificate that is false or misleading or that contains omissions that may affect its accuracy and completeness.
Part 5 · Transitional Provisions, Repeal and Coming into Force
Transitional Provisions
93#
For the purposes of sections 94 and 95, old regulations means the Medical Devices Regulations, C.R.C., c. 871, and Director has the meaning assigned to it by those regulations.
94#
(1)Subject to subsection (2), if an application for a notice of compliance has been submitted with respect to a medical device pursuant to Part V of the old regulations but has not been processed by the Director as of June 30, 1998, an application for a medical device licence shall be made pursuant to these Regulations.
(2)For the purposes of an application for a medical device licence, the information and documents required by paragraphs 32(2)(a) to (e), (3)(a) to (i) or (4)(a) to (o) are deemed to have been submitted if a notice of compliance with respect to the device had been issued under the old regulations.
95#
(1)A medical device that, on June 30, 1998, is being sold in Canada pursuant to the old regulations is not required to be licensed until February 1, 1999, if,
(a)in the case of a device that is subject to Part V of the old regulations, the manufacturer
(i)has a notice of compliance in respect of the device that is in effect on June 30, 1998, or
(ii)does not have a notice of compliance in respect of the device that is in effect on June 30, 1998, but has met, during the period beginning on October 8, 1982, and ending on March 31, 1983, the requirements for device notification pursuant to Part II of the old regulations in respect of the device; and
(b)in the case of a device that is not subject to Part V of the old regulations, the manufacturer has, by June 30, 1998, furnished the Director with the notification required in subsection 24(1) of the old regulations in respect of the device.
(2)If an initial application for licensing of a medical device that is referred to in subsection (1) is submitted before February 1, 1999, the information and documents required by paragraphs 32(2)(a) to (e), (3)(a) to (i) or (4)(a) to (o) are deemed to have been submitted if
(a)in the case of a device that is subject to Part V of the old regulations, the manufacturer
(i)has a notice of compliance in respect of the device that is in effect on June 30, 1998, or
(ii)does not have a notice of compliance that is in effect on June 30, 1998, in respect of the device, but has met, during the period beginning on October 8, 1982, and ending on March 31, 1983, the requirements for device notification pursuant to Part II of the old regulations in respect of the device;
(b)in the case of a device that is not subject to Part V of the old regulations, the manufacturer has, by June 30, 1998, furnished the Director with the notification required in subsection 24(1) of the old regulations in respect of the device.
(3)Subsections (1) and (2) cease to apply in respect of a medical device if a change described in section 34 is made in respect of the device or if the notice of compliance is suspended or cancelled under section 40 of the old regulations.
(4)For the purposes of this section, a notice of compliance may be suspended or cancelled under section 40 of the old regulations as if that section were still in force.
note
Repeal
Coming into Force
97#
(1)Subject to subsections (2) to (5), these Regulations come into force on July 1, 1998.
(2)Section 32, except paragraphs (2)(f), (3)(j) and (4)(p), comes into force
(a)in the case of a medical device referred to in section 94 or 95, on September 1, 1998;
(b)in the case of any other medical device, on July 1, 1998.
(3)Paragraphs 32(2)(f), (3)(j) and (4)(p) come into force on January 1, 2003.
(4)Sections 43 and 44 come into force on January 1, 1999.
(5)Sections 45 to 51 come into force on November 1, 1998.
Schedule 1 · Classification Rules for Medical Devices (Section 6)
Medical Devices other than in Vitro Diagnostic DevicesInvasive DevicesRule 1:(1) Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II.(2) A surgically invasive device that is intended to diagnose, monitor, control or correct a defect of the central cardiovascular system or the central nervous system or of a fetus in utero is classified as Class IV.(3) A surgically invasive device that is intended to be absorbed by the body, or that is normally intended to remain in the body for at least 30 consecutive days, is classified as Class III.Rule 2:(1) Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II.(2) A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.(3) A device described in subrule (1) that is normally intended to remain in the body or in contact with the surface of the eye for at least 30 consecutive days is classified as Class III.(4) A device described in subrule (1) that is intended to be represented as preventing the transmission of infectious agents during sexual activities or reducing the risk thereof is classified as Class III.Rule 3:Despite rules 1 and 2(a) all denture materials and orthodontic appliances, and their accessories, are classified as Class II;(b) all surgical or dental instruments are classified as Class I; and(c) all latex condoms are classified as Class II.Non-invasive DevicesRule 4:(1) Subject to subrule (2), all non-invasive devices that are intended to come into contact with injured skin are classified as Class II.(2) A device described in subrule (1) that is intended to be used as a mechanical barrier, for compression or for absorption of exudations, is classified as Class I.Rule 5:A non-invasive device intended for channelling or storing gases, liquids, tissues or body fluids for the purpose of introduction into the body by means of infusion or other means of administration is classified as Class II.Rule 6:(1) Subject to subrules (2) and (3), a non-invasive device intended for modifying the biological or chemical composition of blood or other body fluids, or liquids, for the purpose of introduction into the body by means of infusion or other means of administration is classified as Class III.(2) A device described in subrule (1) whose characteristics are such that the modification process may introduce a foreign substance into the body that is potentially hazardous, taking into account the nature and quantity of the substance, is classified as Class IV.(3) A device described in subrule (1) that accomplishes the modification by centrifugation, gravity filtration or the exchange of gas or heat is classified as Class II.Rule 7:(1) Subject to subrule (2), all other non-invasive devices are classified as Class I.(2) A device described in subrule (1) is classified as Class II if it is intended(a) to act as a calibrator, tester or quality control support to another medical device; or(b) to be connected to an active device that is classified as Class II, III or IV.Active DevicesRule 8:(1) Subject to subrules (2) and (3), an active device intended to emit ionizing radiation, including any device or software intended to control or monitor such a device or directly influence its performance, is classified as Class III.(2) A device described in subrule (1) that is intended to be used in radiographic mode is classified as Class II.(3) Despite subrule (2), an active device that is intended to be used for mammographies is classified as Class III.Rule 9:(1) Subject to subrules (2) and (3), an active therapeutic device, including any dedicated software, intended to be used to administer or withdraw energy to or from the body is classified as Class II.(2) If the administration or withdrawal by a device described in subrule (1) is potentially hazardous, taking into account the nature of the administration or withdrawal, the intensity of the energy and the part of the body concerned, the device is classified as Class III.(3) A device described in subrule (2) that is intended to control the treatment of a patient’s condition through a closed loop system is classified as Class IV.Rule 10:(1) Subject to subrule (2), an active diagnostic device, including any dedicated software, that supplies energy for the purpose of imaging or monitoring physiological processes is classified as Class II.(2) A device described in subrule (1) that is intended to be used to monitor, assess or diagnose a disease, a disorder, an abnormal physical state or a pregnancy, if erroneous readings could result in immediate danger, is classified as Class III.Rule 11:(1) Subject to subrules (2) and (3), an active device, including any dedicated software, intended to administer drugs, body fluids or other substances to the body or withdraw them from the body is classified as Class II.(2) If the administration or withdrawal by a device described in subrule (1) is potentially hazardous, taking into account the nature of the administration or withdrawal, the nature of the substance involved and the part of the body concerned, the device is classified as Class III.(3) A device described in subrule (2) that is intended to control the treatment of a patient’s condition through a closed loop system is classified as Class IV.Rule 12:Any other active device is classified as Class I.Special RulesRule 13:A medical device that is intended to be used for(a) disinfecting or sterilizing blood, tissues or organs that are intended for transfusion or transplantation is classified as Class IV; and(b) disinfecting or sterilizing a medical device is classified as Class II.Rule 14:(1) Subject to subrule (2), the following medical devices are classified as Class IV:(a) a medical device that is manufactured from or that incorporates human or animal cells or tissues or their derivatives; and(b) a medical device that is manufactured from or that incorporates a product produced through the use of recombinant DNA technology.(2) A device described in subrule (1) that is intended to come into contact with intact skin only is classified as Class I.Rule 15:Any medical device that is a material intended to be sold to a health care professional or dispenser for the specific purpose of configuration or arrangement into a mould or shape to meet the needs of an individual is classified in the class that applies to the finished medical device.Rule 16:Despite rules 1 to 15, a medical device set out in column 1 of an item of the table to this rule is classified as the class set out in column 2 of that item.Item | Column 1 | Column 2Medical device | Class1 | Breast implants | IV2 | Tissue expanders for breast reconstruction and augmentation | IVIn Vitro Diagnostic DevicesUse with respect to Transmissible AgentsRule 1:An IVDD that is intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, tissues or organs to assess their suitability for transfusion or transplantation is classified as Class IV.Rule 2:An IVDD that is intended to be used to detect the presence of, or exposure to, a transmissible agent is classified as Class II, unless(a) it is intended to be used to detect the presence of, or exposure to, a transmissible agent that causes a life-threatening disease if there is a risk of propagation in the Canadian population, in which case it is classified as Class IV; or(b) it falls into one of the following categories, in which case it is classified as Class III:(i) it is intended to be used to detect the presence of, or exposure to, a transmissible agent that causes a serious disease where there is a risk of propagation in the Canadian population,(ii) it is intended to be used to detect the presence of, or exposure to, a sexually transmitted agent,(iii) it is intended to be used to detect the presence of an infectious agent in cerebrospinal fluid or blood, or(iv) there is a risk that an erroneous result would cause death or severe disability to the individual being tested, or to the individual’s offspring.Rule 3:An IVDD that is intended to be used for patient management is classified as Class II, unless it falls into one of the following categories, in which case it is classified as Class III:(a) it is intended to be used for the management of patients suffering from a life-threatening disease; or(b) there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient.Other UsesRule 4:An IVDD that is not subject to rules 1 to 3 and that is intended to be used in diagnosis or patient management is classified as Class II, unless it falls into one of the following categories, in which case it is classified as Class III:(a) it is intended to be used in screening for or in the diagnosis of cancer;(b) it is intended to be used for genetic testing;(c) it is intended to be used in screening for congenital disorders in the fetus;(d) there is a risk that an erroneous diagnostic result would cause death or severe disability to the patient being tested or to that patient’s offspring;(e) it is intended to be used for disease staging; or(f) it is intended to be used to monitor levels of drugs, substances or biological components, if there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient.Rule 5:An IVDD that is intended to be used for blood grouping or tissue typing to ensure the immunological compatibility of blood, blood components, tissue or organs that are intended for transfusion or transplantation is classified as Class III.Special RulesRule 6:A near patient IVDD is classified as Class III.Rule 7:In cases where an IVDD, including its analyzers, reagents and software, is intended to be used with another IVDD, the class of both IVDDs will be that of the IVDD in the class representing the higher risk.Rule 8:If rules 1 to 7 do not apply, all other IVDDs are classified as Class I.Rule 9:Despite rules 1 to 8, an IVDD set out in column 1 of an item of the table to this rule is classified as the class set out in column 2 of that item.Item | Column 1 | Column 2IVDD | Class1 | Near patient in vitro diagnostic device for the detection of pregnancy or for fertility testing | II2 | Near patient in vitro diagnostic device for determining cholesterol level | II3 | Microbiological media used to identify or infer the identity of a microorganism | I4 | IVDD used to identify or infer the identity of a cultured microorganism | I
Schedule 2 · Implants (Section 1)
1 Heart valve2 Annuloplasty ring3 Active implantable device systems(a) all models of implantable pacemakers and leads;(b) all models of implantable defibrillators and leads;(c) artificial heart;(d) implantable ventricular support system; and(e) implantable drug infusion system4 Devices of human origin(a) human dura mater; and(b) wound covering containing human cells
Schedule 3 · Export Certificate for Medical Devices (Section 89)
UNDER THE Medical Devices RegulationsI, , certify that I have knowledge of all matters contained in this certificate and that1 I am (check applicable box)(a) where the medical device described in this certificate is exported by a corporation☐ the exporter’s senior executive officer,☐ the exporter’s senior regulatory officer,☐ the authorized agent of the exporter’s senior executive officer, or☐ the authorized agent of the exporter’s senior regulatory officer; and(b) where the medical device described in this certificate is exported by an individual☐ the exporter, or☐ the exporter’s authorized agent., (State name and address of exporter or, if a corporation, name and address of principal place of business in Canada).2 On the day of , , a package containing (description of device, including serial number, model name, lot number and quantity, as applicable; if additional space required, attach as Appendix “A”) is/will be consigned to (name and address of consignee).3 The package is marked in distinct overprinting with the word “Export” or “Exportation”.4 The medical device was not manufactured for consumption in Canada.5 The medical device is not sold for consumption in Canada.6 The package and its contents do not contravene any known requirement of the law of the country of (state country of consignee).7 All relevant information is contained in this certificate and no relevant information has been knowingly withheld.SignaturePosition title, Date
Amendments not in force
— SOR/2026-96, s. 26Section 43 of the Medical Devices Regulations is amended by adding the following after subsection (3):noteFor greater certainty, subsection (3) does not remove the requirement for the holder of a medical device licence to post information under subsection 62.241(1). — SOR/2026-96, s. 27The heading before section 62.21 and sections 62.21 and 62.22 of the Regulations are replaced by the following:Shortages and Discontinuation of SaleThe following definitions apply in this section and in sections 62.22 to 62.25.List of Medical Devices — Shortages and Discontinuation of Sale means the List of Medical Devices — Shortages and Discontinuation of Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste d’instruments médicaux — pénuries et cessation de la vente)specified medical device means a medical device that belongs to a category of medical devices that is set out in the List of Medical Devices — Shortages and Discontinuation of Sale. (instrument médical inscrit)In sections 62.23 and 62.241, designated website meansif a hyperlink is on the Government of Canada website in accordance with section 62.25, the website that is maintained under contract with His Majesty in right of Canada; andif not, the part of the Government of Canada website that is represented as being for the purpose of posting information under sections 62.23 and 62.241.Sections 62.23 to 62.242 do not apply toa retailer; ora health care facility in respect of a medical device that is distributed for use within that facility.The Minister may add a category of medical devices to the List of Medical Devices — Shortages and Discontinuation of Sale only if the Minister has reasonable grounds to believe that a shortage, or discontinuation of sale in Canada, of any device that belongs to that category, if it were to occur, could present a risk of injury to human health. — SOR/2026-96, s. 28The portion of subsection 62.23(1) of the Regulations before paragraph (b) is replaced by the following:Subject to subsections (5) and (7), if a shortage of a specified medical device exists or is likely to occur, the manufacturer of the device and, in the case of a Class I device, the importer of the device shall each post the following information in English and French on the designated website:the name and contact information of the manufacturer and, if the information is posted by the importer, the name and contact information of the importer;Paragraph 62.23(1)(d) of the Regulations is replaced by the following:the name of the device, including, if applicable, the model name;Subsection 62.23(1) of the Regulations is amended by striking out “and” at the end of paragraph (h), by adding “and” at the end of paragraph (g) and by repealing paragraph (i).Subsections 62.23(2) to (9) of the Regulations are replaced by the following:Subject to subsection (6), the manufacturer or importer shall post the informationif the manufacturer or importer anticipates that a shortage will begin in more than six months, at least six months before the day on which they anticipate it to begin;if the manufacturer or importer anticipates that a shortage will begin in six months or less, within five days after the day on which they make that determination; orif the manufacturer or importer did not anticipate the shortage, within five days after the day on which they become aware of it.If any of the information that was posted under subsection (1) changes, the manufacturer or importer shall update that information on the designated website within two days after the day on which the manufacturer or importer makes or becomes aware of the change.Within two days after the day on which the manufacturer is again able to meet the demand for the specified medical device, the manufacturer or importer shall post information on the designated website to that effect.The manufacturer or importer is not required to post information on the designated website in respect of a specified medical device if, within the applicable period referred to in any of paragraphs (2)(a) to (c), the manufacturer or importer anticipates that the manufacturer will be able to meet the demand for the device within 30 days afterthe day on which the manufacturer or importer anticipates the shortage to begin; orif the manufacturer or importer did not anticipate the shortage, the day on which the shortage began.Despite subsection (5), if the manufacturer or importer subsequently determines that the manufacturer will be unable to meet the demand for the specified medical device within the 30-day period, the manufacturer or the importer shall post the information that is required under subsection (1) on the designated website within five days after the day on which the manufacturer or importer makes that determination.This section does not apply in respect of a shortage of a medical device that results from a decision by the manufacturer to discontinue its sale. — SOR/2026-96, s. 29Sections 62.24 and 62.25 of the Regulations are replaced by the following:Despite section 62.23, the manufacturer of a specified medical device may permit the importer of the device to post the information that is required under that section on the manufacturer’s behalf.The manufacturer shall notify the Minister, in the form and manner specified by the Minister, if the manufacturer has permitted the importer to post the information on the manufacturer’s behalf.Subject to subsection (5), if the manufacturer of a specified medical device or, in the case of a Class I device, the importer of the device decides to discontinue the sale of the device in Canada, the manufacturer or importer shall post the following information in English and French on the designated website:the name and contact information of the manufacturer and, if the information is posted by the importer, the name and contact information of the importer;in the case of a licensed device, the medical device licence number;in the case of a device for which the manufacturer holds an authorization issued under section 68.12, the authorization number;the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;the name of the device, including, if applicable, the model name;a description of the device and of its packaging and an indication of whether it is a single-use device; andthe reason for the discontinuation of sale.For greater certainty, subsection (1) does not remove the requirement fora manufacturer that is the holder of a medical device licence to inform the Minister under subsection 43(3); ora manufacturer that is the holder of an authorization issued under section 68.12 to inform the Minister under section 68.25.The manufacturer or importer shall post the informationif the manufacturer or importer decides to discontinue the sale of the device in more than 12 months, at least 12 months before the day on which they will discontinue its sale; andif the manufacturer or importer decides to discontinue the sale of the device in 12 months or less, within five days after the day on which they make that decision.If any of the information that was posted under subsection (1) changes, the manufacturer or importer shall update that information on the designated website within five days after the day on which the manufacturer or importer makes or becomes aware of the change.The manufacturer or importer is not required to post information on the designated website in respect of a specified medical device if the manufactureris also the manufacturer of a new version of the device that is compatible with all of the components, parts and accessories of the device; andis able to meet the demand in Canada for the new version of the device.Despite section 62.241, the manufacturer of a specified medical device may permit the importer of the device to post the information that is required under that section on the manufacturer’s behalf.The manufacturer shall notify the Minister, in the form and manner specified by the Minister, if the manufacturer has permitted the importer to post the information on the manufacturer’s behalf.If a person maintains a website under contract with His Majesty in right of Canada for the purpose of posting information under sections 62.23 and 62.241, the Minister shall ensure that a hyperlink to that website is on the Government of Canada website. — SOR/2026-96, s. 39Section 68.25 of the Regulations is renumbered as subsection 68.25(1) and is amended by adding the following:For greater certainty, subsection (1) does not remove the requirement for the holder to post information under subsection 62.241(1). — SOR/2026-110, s. 1Subsection 44(4) of the Medical Devices Regulations is replaced by the following:noteSubsection (3) does not apply toa person who imports a Class I medical device from the manufacturer of that device and who holds an establishment licence;a person who imports a Class II, III or IV medical device from the manufacturer of that device; ora person who imports any medical device from a person other than the manufacturer of that device and who holds an establishment licence. — SOR/2026-110, s. 2Paragraph 45(e) of the Regulations is repealed.Section 45 of the Regulations is amended by adding the following after paragraph (f):the name and address of any person, other than the manufacturer, who sells a medical device to the establishment for the purposes of importation or distribution;for each person referred to in paragraph (f.1), other than the manufacturer, the classes of the devices that are being imported or distributed; andParagraphs 45(g) to (i) of the Regulations are repealed.Paragraph 45(j) of the Regulations is replaced by the following:the address of each building where the procedures described in any of sections 52, 58, 58.1 and subsections 59(3) and (4) and 61.2(4) are in place. — SOR/2026-110, s. 3Subsection 46.1(1) of the Regulations is replaced by the following:The holder of an establishment licence that is not suspended must submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referred to in section 45, including any updates to the information or documents, as the case may be. — SOR/2026-110, s. 4Section 52 of the Regulations is amended by adding the following after subsection (2):The manufacturer, importer and distributor of a medical device must each establish, implement and maintain documented procedures for maintaining the distribution records. — SOR/2026-110, s. 5The portion of section 58 of the Regulations before paragraph (a) is replaced by the following:The manufacturer, importer and distributor of a medical device must each establish, implement and maintain documented procedures that enable them to carry out — SOR/2026-110, s. 6The Regulations are amended by adding the following after section 58:Handling, Storage, Delivery, Installation, Servicing and Corrective ActionThe manufacturer, importer and distributor of a Class II, III or IV medical device must each establish, implement and maintain documented procedures for, as applicable, the handling, storage, delivery, installation and servicing of the device and the taking of corrective action in respect of it. — SOR/2026-110, s. 7Section 59 of the Regulations is amended by adding the following after subsection (2):The manufacturer and importer of a Class I medical device must each establish, implement and maintain documented procedures for making any preliminary and final reports referred to in subsections (1) and (1.1).The manufacturer and importer of a Class II, III or IV medical device must each establish, implement and maintain documented procedures for making any preliminary and final reports referred to in subsection (1). — SOR/2026-110, s. 8Section 61.2 of the Regulations is amended by adding the following after subsection (3):The holder of a medical device licence and the importer of a Class II, III or IV medical device must each establish, implement and maintain documented procedures that enable the effective and timely provision of information referred to in subsection (2). — SOR/2026-110, s. 9Unless the context requires otherwise, the words and expressions used in this section have the same meaning as in the Medical Devices Regulations.A person who has submitted an application for an establishment licence under section 45 of the Medical Devices Regulations, as it read before the day on which these Regulations come into force, and in respect of which no decision has been made before that day, must not be issued the licence unless, by that day and in the form established by the Minister, the person provides the Minister with the information referred to in paragraphs 45(f.1) and (f.2) of those Regulations, as amended by these Regulations.
Federal laws of Canada reproduced under the Reproduction of Federal Law Order (SI/97-5); not the official version. Source: Justice Laws Website.