Therapeutic Goods (Medical Devices) Regulations 2002

Contents

4,072 provisions, too many to show on one page. Open a part or section to read it with its history and connections, or search inside the text.

Part 1 · Preliminary
1. 1.1 Name of Regulations
2. 1.3 Definitions—the dictionary etc
3. 1.4 Medical devices with a measuring function
4. 1.5 Refurbishment (Act s 3(1))
5. 1.6 Kinds of medical devices—other common characteristics (Act s 41BE(1)(e))
6. 1.7 Device nomenclature system codes (Act s 41BE(3))
7. 1.8 Classes of persons that are not manufacturers of a medical device
Part 2 · Essential principles
1. 2.1 Essential principles (Act s 41CA)
Part 3 · Conformity assessment procedures
1. Division 3.1 Medical device classifications
2. Division 3.2 Conformity assessment procedures
Part 4 · Conformity assessment certificates
1. Division 4.1 Issuing conformity assessment certificates
2. Division 4.1A Conformity assessment (priority applicant) determinations
3. Division 4.1B Content of conformity assessment certificates
4. Division 4.1C Conditions
5. Division 4.2 Suspension of conformity assessment certificates
6. Division 4.3 Transfer of conformity assessment certificates
Part 4A · Australian conformity assessment bodies
1. Division 4A.1 Preliminary
2. Division 4A.2 Making conformity assessment body determinations
3. Division 4A.3 Conditions on conformity assessment body determinations
4. Division 4A.4 Suspension of conformity assessment body determinations
5. Division 4A.5 Revocation of conformity assessment body determinations
6. Division 4A.6 Variation of conformity assessment body determinations
7. Division 4A.7 Australian conformity assessment body certificates
Part 5 · Including medical devices in the Register
1. Division 5.1 Including medical devices in the Register
2. Division 5.2 Conditions
Part 6 · Suspension and cancellation from the Register
1. 6.1 Period for revocation of suspension (Act s 41GD, s 63(2)(dd))
Part 6A · Disposal of unused emergency medical devices
1. 6A.1 Disposal of unused emergency medical devices
Part 7 · Exempting medical devices from inclusion in the Register
1. Division 7.1 Exempt devices
2. Division 7.2 Exemptions for experimental uses
3. Division 7.3 Exemptions for medical practitioners
Part 8 · Obtaining information
1. 8.1A Matters for which information and documents can be requested
2. 8.1 Notice period (Act s 41JA)
Part 8AA · Mandatory reporting of adverse events by healthcare facilities
1. 8AA.1 Healthcare facilities
2. 8AA.2 Reportable medical devices
3. 8AA.3 Report requirements
Part 8A · Waiver and refund of charges
1. 8A.1 Definitions
2. 8A.2 Waiver of charges in relation to transitional medical devices
3. 8A.3 Refund of certain charges in relation to transitional medical devices
Part 9 · Fees
1. Division 9.1 Fees
2. Division 9.1A Reduced fee for consent to import, supply or export implantable medical devices—information requirements
3. Division 9.2 Conformity assessment body determination assessment fees
4. Division 9.3 Assessment fees and reductions or refunds of fees connected with applications for conformity assessment certificates
5. Division 9.4 Other refunds or waivers of fees
Part 9A · Australian Unique Device Identification Database
1. 9A.1 Australian Unique Device Identification Database
Part 10 · Miscellaneous
1. 10.1 Authorised persons
2. 10.2 Information about sponsor
3. 10.3 Custom-made medical devices—information about manufacturer
4. 10.3A Custom-made medical devices—information about supplies
5. 10.4 Offences—period for notifying adverse events (Act s 41MP)
6. 10.4AA Civil penalty—period for notifying adverse events
7. 10.4A Secretary may maintain a system to enhance safe and effective use of particular medical devices
8. 10.5 Delegation—powers and functions under these Regulations
9. 10.6A Delegation of Secretary’s powers under section 41HD of the Act
10. 10.6B Forms or manners—software requirements
11. 10.7 Review of decisions
Part 11 · Transitional provisions
1. Division 11.1 Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1)
2. Division 11.2 Transitional provisions relating to joint replacements
3. Division 11.3 Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015
4. Division 11.4 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016
5. Division 11.5 Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017
6. Division 11.6 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017
7. Division 11.7 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018
8. Division 11.8 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018
9. Division 11.9 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018
10. Division 11.10 Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019
11. Division 11.11 Application provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020
12. Division 11.12 Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021
13. Division 11.13 Application, saving and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021
14. Division 11.14 Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021
15. Division 11.15 Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 2) Regulations 2022
16. Division 11.16 Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022
17. Division 11.17 Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023
18. Division 11.18 Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023
19. Division 11.19 Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023
20. Division 11.20 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024
21. Division 11.21 Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024
22. Division 11.22 Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024
23. Division 11.23 Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024
24. Division 11.24 Application provisions relating to the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
25. Division 11.25 Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025
26. Division 11.26 Application provisions relating to the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026
27. Division 11.27 Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2026
Dictionary
1. (regulation 1.3)
2. Note: A number of expressions used in these Regulations are defined in the Act.
3. Act means the Therapeutic Goods Act 1989.
4. active implantable medical device means an active medical device, other than an implantable medical device, that is intended by the manufacturer:
5. (a) either:
6. (i) to be, by surgical or medical intervention, introduced wholly, or partially, into the body of a human being; or
7. (ii) to be, by medical intervention, introduced into a natural orifice in the body of a human being; and
8. (b) to remain in place after the procedure.
9. active medical device:
10. (a) means a medical device that is intended by the manufacturer:
11. (i) to depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or
12. (ii) to act by converting this energy; but
13. (b) does not include a medical device that is intended by the manufacturer to transmit energy, a substance, or any other element, between an active medical devi
14. Software that is a medical device is an active medical device.
15. active medical device for diagnosis means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combinat
16. active medical device for therapy means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combinatio
17. adaptable medical device means a mass-produced medical device that is intended by the manufacturer to be assembled or adapted after it has been supplied, in acc
18. (a) address either or both of the anatomical and physiological features of a particular individual; or
19. (b) address a pathological condition of a particular individual; or
20. (c) otherwise perform as intended by the manufacturer.
21. AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the healt
22. ancillary medical device means an implantable medical device that:
23. (a) consists of screws, plates or wedges; or
24. (b) is intended by the manufacturer to be used to:
25. (i) provide stability for an implantable medical device that is intended to (either alone or together with one or more other implantable medical devices) replac
26. (ii) provide bone substitution in relation to, or additional fixation for, any such device; or
27. (iii) otherwise assist any such device;
28. where the individual requirements of a patient make it appropriate to do so.
29. animal means an invertebrate or vertebrate member of the animal kingdom.
30. approved indications, of a medicine, biological or other therapeutic goods, means:
31. (a) if the medicine, biological or other therapeutic goods are entered on the Register—the indications included in the Register in relation to the medicine, bio
32. (b) otherwise—the indications in relation to the medicine, biological or other therapeutic goods.
33. Note: For indications, see subsection 3(1) of the Act.
34. approved type means a type that has been examined and approved by the Secretary under the type examination procedures.
35. Australian legal unit of measurement has the meaning given by the National Measurement Act 1960.
36. Australian Unique Device Identification Database: see regulation 9A.1.
37. authorised person—see regulation 10.1.
38. body orifice:
39. (a) means a natural opening, or a permanent artificial opening, in a human being’s body; and
40. (b) includes the external surface of a human being’s eyeball.
41. central circulatory system means the system in a human being comprising the following vessels:
42. (a) arteriae pulmonales;
43. (b) aorta ascendens;
44. (c) arteriae coronariae;
45. (d) arteria carotis communis;
46. (e) arteria carotis externa;
47. (f) arteria carotis interna;
48. (g) arteriae cerebrales;
49. (h) trucus brachicephalicus;
50. (i) venae cordis;
51. (j) venae pulmonales;
52. (k) venae cava superior;
53. (l) venae cava inferior;
54. (m) arcus aorta;
55. (n) thoracica aorta;
56. (o) abdominalis aorta;
57. (p) arteriae ilica communis.
58. central nervous system means the system in a human being comprising the brain, meninges and spinal cord.
59. Class 1 in-house IVD medical device means an in-house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 1.
60. Class 1 IVD medical device means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 1.
61. Class I medical device means a medical device that, under Division 3.1 of Part 3, is classified as Class I.
62. Class 2 in-house IVD medical device means an in-house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 2.
63. Class 2 IVD medical device means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 2.
64. Class IIa medical device means a medical device that, under Division 3.1 of Part 3, is classified as Class IIa.
65. Class IIb medical device means a medical device that, under Division 3.1 of Part 3, is classified as Class IIb.
66. Class 3 in-house IVD medical device means an in-house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 3.
67. Class 3 IVD medical device means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 3.
68. Class III medical device means a medical device that, under Division 3.1 of Part 3, is classified as Class III.
69. Class 4 in-house IVD medical device means an in-house IVD medical device that, under Division 3.1 of Part 3, is classified as Class 4.
70. Class 4 IVD medical device means an IVD medical device that, under Division 3.1 of Part 3, is classified as Class 4.
71. classification means a medical device classification.
72. classification rules, in relation to a medical device, means the rules for classifying the device set out in Schedule 2.
73. client of an Australian conformity assessment body means a manufacturer with whom the body has an agreement under which the body will carry on certification-rel
74. clinical evaluation procedures means the conformity assessment procedures set out in Part 8 of Schedule 3.
75. conformity assessment body determination assessment fee means a fee payable under regulation 9.1B for assessing an application for a conformity assessment body
76. conformity assessment (priority applicant) determination has the meaning given by subsection 41ECA(2) of the Act.
77. custom-made medical device means a medical device that:
78. (a) is intended by the manufacturer to be for:
79. (i) the sole use of a particular patient (the intended recipient); or
80. (ii) the sole use of a particular health professional (the intended recipient) in the course of the health professional’s practice; and
81. (b) is manufactured by the manufacturer in accordance with a written request of a health professional (the requesting health professional) and with particular d
82. (i) either or both of the anatomical and physiological features of the intended recipient; or
83. (ii) a pathological condition of the intended recipient; and
84. (c) the requesting health professional has determined is necessary to address the matters covered by paragraph (b) because there is no kind of medical device in
85. However, a custom-made medical device does not include a patient-matched medical device, an adaptable medical device or other mass-produced medical device.
86. declaration of conformity (not requiring assessment by Secretary) procedures means the conformity assessment procedures set out in Part 6 of Schedule 3.
87. Defence clinical governance committee means a committee established by the Defence Department to perform functions concerned with clinical governance in relatio
88. Defence Department means the Department administered by the Minister administering Part III of the Defence Act 1903, and includes the Australian Defence Force.
89. Defence medical practitioner means a medical practitioner engaged by the Defence Department.
90. device lifetime, in relation to a medical device, means the period, indicated by the manufacturer, during which:
91. (a) the device can be safely used; and
92. (b) the characteristics and performance of the device are not affected by its age.
93. device nomenclature system code, for a medical device, means the device nomenclature system code mentioned for the device in regulation 1.7.
94. direct marking start day, for a UDI medical device, means the following day:
95. (a) for a Class I medical device that is supplied in a sterile state—1 July 2029;
96. (b) for a Class IIa medical device—1 January 2029;
97. (c) for a Class IIb medical device—1 January 2029:
98. (d) for a Class III medical device—1 January 2028;
99. (e) for a Class 1 IVD medical device with a Global Medical Device Nomenclature System Code of CT944 or CT943—1 July 2030;
100. (f) for a Class 2 IVD medical device—1 July 2030;
101. (g) for a Class 3 IVD medical device—1 July 2029;
102. (h) for a Class 4 IVD medical device—1 July 2029.
103. engagement by the Defence Department means engagement by the Defence Department to perform duties for the Defence Department, whether as an employee, a contract
104. essential principles means the essential principles set out in Schedule 1.
105. EU certificate means an overseas regulator conformity assessment document issued under either of the following (as in force from time to time):
106. (a) Council Directive 93/42/EEC of the Council of the European Communities;
107. (b) Directive 98/79/EC of the European Parliament and the Council of the European Union.
108. EU IVD regulation has the meaning given by subclause 2(3) of Schedule 3AA.
109. EU medical devices regulation has the meaning given by subclause 2(2) of Schedule 3AA.
110. faecal microbiota transplant product means a thing that:
111. (a) comprises, contains or is derived from human stool; and
112. (b) is for introduction into a person for a therapeutic use.
113. full designation conformity assessment body determination means a conformity assessment body determination that is of general application.
114. full quality assurance procedures means the conformity assessment procedures set out in Part 1 of Schedule 3.
115. general start day, for a UDI medical device, means the following day:
116. (a) for a Class I medical device that is supplied in a sterile state:
117. (i) if, on 30 June 2028, an EU certificate is in force covering the medical device—1 January 2029; or
118. (ii) otherwise—1 July 2028;
119. (b) for a Class IIa medical device:
120. (i) if, on 30 June 2027, an EU certificate is in force covering the medical device—1 January 2029; or
121. (ii) otherwise—1 July 2027;
122. (c) for a Class IIb medical device that is an implantable medical device:
123. (i) if, on 30 June 2026, an EU certificate is in force covering the medical device and the medical device has been manufactured and labelled, but not supplied i
124. (ii) if, on 30 June 2026, an EU certificate is in force covering the medical device and subparagraph (i) does not apply—1 January 2028; or
125. (iii) if, on 30 June 2026, no EU certificate is in force covering the medical device and the medical device has been manufactured and labelled, but not supplied
126. (iv) if, on 30 June 2026, no EU certificate is in force covering the medical device and subparagraph (iii) does not apply—1 July 2026;
127. (d) for a Class IIb medical device that is not an implantable medical device:
128. (i) if, on 30 June 2026, an EU certificate is in force covering the medical device and the medical device has been manufactured and labelled, but not supplied i
129. (ii) if, on 30 June 2026, an EU certificate is in force covering the medical device and subparagraph (i) does not apply—1 January 2029; or
130. (iii) if, on 30 June 2026, no EU certificate is in force covering the medical device and the medical device has been manufactured and labelled, but not supplied
131. (iv) if, on 30 June 2026, no EU certificate is in force covering the medical device and subparagraph (iii) does not apply—1 July 2026;
132. (e) for a Class III medical device:
133. (i) if, on 30 June 2026, an EU certificate is in force covering the medical device and the medical device has been manufactured and labelled, but not supplied i
134. (ii) if, on 30 June 2026, an EU certificate is in force covering the medical device and subparagraph (i) does not apply—1 January 2028; or
135. (iii) if, on 30 June 2026, no EU certificate is in force covering the medical device and the medical device has been manufactured and labelled, but not supplied
136. (iv) if, on 30 June 2026, no EU certificate is in force covering the medical device and subparagraph (iii) does not apply—1 July 2026;
137. (f) for a Class 1 IVD medical device with a Global Medical Device Nomenclature System Code of CT944 or CT943:
138. (i) if, on 30 June 2029, an EU certificate is in force covering the medical device—1 January 2030; or
139. (ii) otherwise—1 July 2029;
140. (g) for a Class 2 IVD medical device:
141. (i) if, on 30 June 2029, an EU certificate is in force covering the medical device—1 January 2030; or
142. (ii) otherwise—1 July 2029;
143. (h) for a Class 3 IVD medical device:
144. (i) if, on 30 June 2028, an EU certificate is in force covering the medical device—1 January 2029; or
145. (ii) otherwise—1 July 2028;
146. (i) for a Class 4 IVD medical device—1 July 2028.
147. health professional includes a person who is:
148. (a) a medical practitioner, or a dentist or any other kind of health care worker registered under a law of a State or Territory; or
149. (b) a biomedical engineer, chiropractor, optometrist, orthodontist, osteopath, pharmacist, physiotherapist, podiatrist, prosthetist or rehabilitation engineer.
150. hip joint means the ball and socket formed by the reception of the head of the femur into the cup-shaped cavity of the acetabulum.
151. immediate family of a person means:
152. (a) a spouse, de facto partner, child, parent, grandparent, grandchild or sibling of the person; or
153. (b) a child, parent, grandparent, grandchild or sibling of a spouse or de facto partner of the person.
154. immunohaematology reagent IVD medical device means an IVD medical device that is a reagent, reagent product or related material that is intended by the manufact
155. implantable breast medical device means any of the following implantable medical devices:
156. (a) breast implants or mammary implants;
157. (b) breast tissue expanders;
158. (c) any other medical device that is of a similar kind, or has a similar function, to a medical device mentioned in paragraph (a) or (b).
159. implantable cardiac medical device means any of the following implantable medical devices or active implantable medical devices:
160. (a) cardiac stents;
161. (b) cardiac valves (whether mechanical or of biological origin);
162. (c) electronic devices for regulating heart rate or managing dysrhythmia;
163. (d) any other medical device that is of a similar kind, or has a similar function, to a medical device mentioned in paragraph (a), (b) or (c).
164. implantable medical device means a medical device (other than an active implantable medical device) that is intended by the manufacturer:
165. (a) to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure; or
166. (b) to replace, by surgical intervention, an epithelial surface, or the surface of an eye, of a human being, and to remain in place after the procedure; or
167. (c) to be, by surgical intervention, partially introduced into the body of a human being, and to remain in place for at least 30 days after the procedure.
168. in-house IVD medical device means an IVD medical device that is:
169. (a) within the confines or scope of an Australian laboratory or Australian laboratory network:
170. (i) developed from first principles; or
171. (ii) developed or modified from a published source; or
172. (iii) developed or modified from any other source; or
173. (iv) used for a purpose, other than the intended purpose assigned by the manufacturer; and
174. (b) not supplied for use outside that laboratory or laboratory network.
175. injured skin or mucous membrane means an area of skin or mucous membrane that has evidence of:
176. (a) a pathological change; or
177. (b) a change following:
178. (i) disease; or
179. (ii) a wound.
180. instructions for use, in relation to a medical device, includes information provided by the manufacturer of the device to inform a user of the device of the int
181. Note: These Regulations contain requirements relating to instructions for use of a medical device. For example, clauses 13.1 to 13.4 of Schedule 1 (about essent
182. intended purpose, of a medical device, means the purpose for which the manufacturer of the device intends it to be used, as stated in:
183. (a) the information provided with the device; or
184. (b) the instructions for use of the device; or
185. (c) any advertising material applying to the device; or
186. (d) any technical documentation describing the mechanism of action of the device.
187. invasive medical device means a medical device that is intended by the manufacturer to be used, in whole or in part, to penetrate the body of a human being thro
188. IVD companion diagnostic means an IVD medical device:
189. (a) that is intended by the manufacturer to be used for the examination of a specimen from the body of an individual:
190. (i) to identify whether the individual would be likely to benefit from the use of a particular medicine or biological; or
191. (ii) to identify whether the individual is likely to be at particular risk of a serious adverse reaction to the use of a particular medicine or biological; or
192. (iii) to monitor the individual’s response to the use of a particular medicine or biological; and
193. (b) that is mentioned in product information for the medicine or biological as being essential for the safe and effective use of the medicine or biological; and
194. (c) if the medicine or biological comprises blood, a blood component, cells, tissue or an organ, from a donor other than the individual—that is not intended by
195. IVD medical device, or in vitro diagnostic medical device, means a medical device that is:
196. (a) a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combinatio
197. (b) intended by the manufacturer to be used in vitro for the examination of a specimen derived from the human body, solely or principally for:
198. (i) giving information about a physiological or pathological state or a congenital abnormality; or
199. (ii) determining safety and compatibility with a potential recipient; or
200. (iii) monitoring therapeutic measures; and
201. (c) not a product that is:
202. (i) intended for general laboratory use; and
203. (ii) not manufactured, sold or presented for use as an IVD medical device.
204. IVD medical device for self-testing means an IVD medical device intended to be used:
205. (a) in the home or similar environment by a lay person; or
206. (b) in the collection of a sample by a lay person and, if that sample is tested by another person, the results are returned directly to the person from whom the
207. joint replacement medical device means an implantable medical device:
208. (a) that is intended by the manufacturer to operate (either alone or together with one or more other implantable medical devices) as a replacement (in whole or
209. (b) that (either alone or together with one or more other implantable medical devices):
210. (i) replaces or substitutes for the articulating surface of a shoulder joint, hip joint or knee joint (in whole or in part); or
211. (ii) provides primary fixation to the bone for the replacement articulating surface; or
212. (iii) connects directly or indirectly with an implantable medical device that has a function mentioned in subparagraph (i) or (ii) and operates as an intrinsic
213. but does not include an ancillary medical device.
214. kind, in relation to a medical device—see section 41BE of the Act.
215. knee joint means the joint consisting of:
216. (a) the articulations between each of the 2 condyles of the femur and the corresponding surface of the tibia; and
217. (b) the articulation between the patella and the trochlear groove of the femur.
218. laboratory network means a network of laboratory organisations that satisfies the following:
219. (a) the network operates with a single quality management system;
220. (b) either:
221. (i) the activities of the network span more than one field of testing or program; or
222. (ii) the network operates at multiple sites within a field, or involves a combination of multiple sites and fields or programs.
223. lay person, for the use of an IVD medical device for self-testing, means an individual who does not have formal training in a medical field or discipline to whi
224. manufacturing licence—see subsection 38(1B) of the Act.
225. mass-produced medical device means a medical device that:
226. (a) is manufactured according to standardised dimensions or designs; and
227. (b) is not designed for a particular individual; and
228. (c) is manufactured in a continuous production process or in a homogenous batch.
229. measuring function, in relation to a medical device—see regulation 1.4.
230. medical device packaging identifier, of the packaging of a UDI medical device, means any combination of numbers, symbols and letters given to the packaging to e
231. medical device production system means a system that consists of raw materials and main production equipment (whether or not the system also consists of softwar
232. medical devices (priority applicant) determination has the meaning given by subsection 41FKA(2) of the Act.
233. medical device used for a special purpose means a medical device to which regulation 3.10 applies.
234. nanomaterial has the meaning given by Article 2(18) of Regulation 2017/745 (as in force from time to time) of the European Parliament and the Council of the Eur
235. NATA means the National Association of Testing Authorities.
236. overseas medical practitioner means a person who is registered or licensed to practise medicine under a law of a foreign country that provides for the registrat
237. partial designation conformity assessment body determination (full QMS) means a conformity assessment body determination that is not:
238. (a) a full designation conformity assessment body determination; or
239. (b) a partial designation conformity assessment body determination (partial QMS or partial devices).
240. partial designation conformity assessment body determination (partial QMS or partial devices) means a conformity assessment body determination that:
241. (a) is not a full designation conformity assessment body determination; and
242. (b) covers:
243. (i) the conformity assessment procedures set out in clause 1.6 or Part 2 of Schedule 3 (whether or not the determination also covers other procedures); or
244. (ii) a Class III medical device (whether or not the determination also covers other medical devices).
245. patient implant card has the meaning given by clause 13A.2 of Schedule 1.
246. patient information leaflet has the meaning given by clause 13A.3 of Schedule 1.
247. patient-matched medical device means a medical device that:
248. (a) is manufactured by the manufacturer, within a specified design envelope, to match:
249. (i) either or both of the anatomical and physiological features of a particular individual; or
250. (ii) a pathological condition of a particular individual; and
251. (b) is designed by the manufacturer (even if the design is developed in consultation with a health professional); and
252. (c) is manufactured using production processes that are capable of being:
253. (i) either or both validated and verified; and
254. (ii) reproduced.
255. point of care testing, for an IVD medical device, means testing performed outside the laboratory environment, near to or at the side of the patient, that is not
256. post-production phase, in relation to a medical device, means the period during which the device is stored, transported, supplied for use and used (whether in A
257. principal investigator, in relation to a clinical trial of a kind of medical device, means the person who is in charge of the conduct of the trial.
258. procedures for medical devices used for a special purpose means the conformity assessment procedures set out in Part 7 of Schedule 3.
259. production quality assurance procedures means the conformity assessment procedures set out in Part 4 of Schedule 3.
260. product quality assurance procedures means the conformity assessment procedures set out in Part 5 of Schedule 3.
261. refurbishment, of a medical device—see regulation 1.5.
262. residual risk for a medical device has the meaning given by subclause 2(3) of Schedule 1.
263. retail premises means premises:
264. (a) from which goods or services are available for supply, or are supplied, to a consumer; or
265. (b) that are used in connection with the supply of goods or services to a consumer;
266. (whether or not the premises are used wholly or predominantly for that purpose).
267. Note: For the definition of premises, see subsection 3(1) of the Act.
268. reusable surgical instrument means a medical device that is intended by the manufacturer:
269. (a) to be used surgically, without being connected to an active medical device, for cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipp
270. (b) to be reused after the appropriate procedures (such as cleaning, disinfection and sterilisation) specified by the manufacturer in the instructions for use h
271. sample, for an IVD medical device for self-testing, means 1 or more specimens, taken from the human body, that:
272. (a) are intended to provide information on the human body; and
273. (b) may serve as a basis for a decision on the human body or its processes.
274. serious, for a condition, ailment or defect, means a condition, ailment or defect that is:
275. (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a medical practitioner, or a dentist or other kind of health care
276. (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without supervision by a medical practitioner, or
277. serious disease means a disease that:
278. (a) may result in death or long-term disability; and
279. (b) may be incurable or require major therapeutic interventions; and
280. (c) must be diagnosed accurately, to mitigate the public health impact of the disease.
281. shoulder joint means the ball and socket formed by the reception of the head of the humerus onto the glenoid cavity of the scapula.
282. specialist has the same meaning as in the Health Insurance Act 1973.
283. specified design envelope means minimum and maximum dimensions, performance limits or other relevant factors that:
284. (a) characterise a medical device for production purposes; and
285. (b) may be based on a standard device template.
286. surgically invasive medical device means:
287. (a) an invasive medical device that is intended by the manufacturer to be used with the aid, or in the context, of a surgical operation; and
288. (b) a medical device that is intended by the manufacturer to be used to penetrate the body of a human being in any way other than through a body orifice.
289. therapeutic cannabis vaping device means a medical device that:
290. (a) is a vaping device, other than:
291. (i) a disposable therapeutic vape (within the meaning of the Therapeutic Goods Regulations 1990); or
292. (ii) a component or article imported for use in the manufacture of a therapeutic cannabis vaping device; and
293. (b) is intended, by the person under whose name the device is or is to be supplied, to be used only to administer medicinal cannabis products (within the meanin
294. therapeutic cannabis vaping device accessory means a therapeutic good that is an unfilled cartridge, capsule, pod or other vessel:
295. (a) that is designed or intended only for use in, or with, a therapeutic cannabis vaping device; and
296. (b) that is designed or intended to contain a therapeutic vaping substance; and
297. (c) whether or not the cartridge, capsule, pod or other vessel is designed or intended to be refilled.
298. therapeutic cannabis vaping good means a therapeutic cannabis vaping device or a therapeutic cannabis vaping device accessory.
299. therapeutic vaping device means a therapeutic good that is a vaping device, other than:
300. (a) a disposable therapeutic vape (within the meaning of the Therapeutic Goods Regulations 1990); or
301. (b) a therapeutic cannabis vaping device.
302. therapeutic vaping device accessory means a therapeutic good that is an unfilled cartridge, capsule, pod or other vessel:
303. (a) that is designed or intended for use in, or with, a therapeutic vaping device; and
304. (b) that is designed or intended to contain a therapeutic vaping substance; and
305. (c) whether or not the cartridge, capsule, pod or other vessel is designed or intended to be refilled;
306. but does not include a therapeutic cannabis vaping device accessory.
307. therapeutic vaping substance has the same meaning as in the Therapeutic Goods Regulations 1990.
308. type means a representative sample of a kind of medical device.
309. type examination procedures means the conformity assessment procedures set out in Part 2 of Schedule 3.
310. UDI device identifier, of a UDI medical device, means any combination of numbers, symbols and letters given to the UDI medical device to enable identification o
311. UDI issuing agency means:
312. (a) the international organisation known as GS1; or
313. (b) the international organisation known as the Health Industry Business Communications Council; or
314. (c) the international organisation known as the International Council for Commonality in Blood Banking Automation.
315. UDI medical device means a medical device (other than an in-house IVD medical device) that is covered by an entry in the Register and is:
316. (a) a Class I medical device that is intended by the manufacturer to be supplied in a sterile state; or
317. (b) a Class IIa medical device; or
318. (c) a Class IIb medical device; or
319. (d) a Class III medical device; or
320. (e) a Class 1 IVD medical device with a Global Medical Device Nomenclature System Code of CT944 or CT943; or
321. (f) a Class 2 IVD medical device; or
322. (g) a Class 3 IVD medical device; or
323. (h) a Class 4 IVD medical device.
324. UDI production identifier, of a UDI medical device, means any combination of numbers, symbols and letters given to the UDI medical device to enable identificati
325. unique product identifier of a medical device means the unique product identifier (for example, the product name or model number) given to the device by its man
326. unused emergency medical devices means medical devices to which section 41GY of the Act applies.
327. user of a medical device means any person (including a health professional) who uses the device.
328. variant means a medical device, the design of which has been varied, to accommodate different patient anatomical requirements (for example, relating to the shap
329. verification procedures means the conformity assessment procedures set out in Part 3 of Schedule 3.
Schedule 1 · Essential principles
1. (regulation 2.1)
2. Part 1 General principles
3. Part 2 Other principles
Schedule 2 · Classification rules for medical devices other than IVD medical devices
1. Note: Regulation 3.2 provides for the making of classification rules. Regulation 3.3 sets out the principles for applying those rules.
2. Part 1 Interpretation
3. Part 2 Rules for non-invasive medical devices
4. Part 3 Rules for invasive medical devices and implantable medical devices
5. Part 4 Special rules for active medical devices
6. Part 5 Special rules for particular kinds of medical devices
Schedule 2A · Classification rules for IVD medical devices
1. Note: Regulation 3.2 provides for the making of classification rules. Regulation 3.3 sets out the principles for applying those rules.
2. 1.1 Detection of transmissible agents posing high public health risk
3. 1.2 Detection of red blood cell antigens and antibodies and non-red cell typing
4. 1.3 Detection of transmissible agents or biological characteristics posing moderate public health risk or high personal risk
5. 1.4 IVD medical devices for self-testing
6. 1.5 Non assay-specific quality control material
7. 1.6 Reagents, instruments etc
8. 1.7 Other IVD medical devices are Class 2 IVD medical devices
9. 1.8 IVD medical devices intended for export only
Schedule 3 · Conformity assessment procedures
1. (regulation 3.4)
2. Part 1 Full quality assurance procedures
3. Part 2 Type examination procedures
4. Part 3 Verification procedures
5. Part 4 Production quality assurance procedures
6. Part 5 Product quality assurance procedures
7. Part 6 Declaration of conformity (not requiring assessment by Secretary) procedures
8. Part 6A Procedures applying to Class 1, 2 and 3 in-house IVD medical devices
9. Part 6B Procedures applying to Class 4 in-house IVD medical devices
10. Part 7 Procedures for medical devices used for a special purpose
11. Part 8 Clinical evaluation procedures
Schedule 3AA · Requirements for Australian conformity assessment bodies
1. Note: See Part 4A.
2. 1 Purpose of this Schedule
3. 2 EU Regulations
4. 3 Modifications of EU Regulations—general
5. 4 Additional requirements
6. 5 Additional modifications of EU medical devices regulations
7. 6 Modifications of EU IVD regulations
8. 7 Expressions used in modifications
Schedule 3A · Disposal of unused emergency medical devices
1. (regulation 6A.1)
2. 1 Early end of exemption—notice of medical devices held
3. 2 End of exemption period—notice of medical devices held
4. 3 Storage and disposal of unused emergency medical devices
5. 4 Direction for disposal of unused emergency medical devices
6. 5 Relocation of unused emergency medical devices
7. 6 Disposal of unused emergency medical devices—destruction
8. 7 Disposal of unused emergency medical devices—export
9. 8 Disposal of unused emergency medical devices—supply
10. 9 Owner to be paid for medical devices supplied
11. 10 Records about unused emergency medical devices
12. 11 Failure to comply with this Schedule
Schedule 4 · Exempt devices
1. (regulation 7.1)
2. Part 1 Exempt devices—general
3. Part 2 Exempt devices—exemption subject to conditions
Schedule 5 · Fees
1. (regulation 9.1)
2. Part 1 General
3. Part 2 Additional fees

Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.