Therapeutic Goods (Medical Devices) Regulations 2002

In force

Administered by

Department of Health, Disability and Ageing

This item is authorised by the following title:

Therapeutic Goods Act 1989

Superseded version

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View as made version

F2007C00385 C10

01 July 2007 - 03 October 2007

This instrument was backcaptured in accordance with Section 36 of the Legislative Instruments Act 2003

Table of contents

1.1 Name of Regulations [see Note 1]
1.2 Commencement [see Note 1]
1.3 Definitions — the dictionary etc
1.4 Medical devices with a measuring function
1.5 Refurbishment (Act s 3 (1))
1.6 Kinds of medical devices — other common characteristics (Act s 41BE (1) (e))
1.7 Device nomenclature system codes (Act s 41BE (3))
2.1 Essential principles (Act s 41CA)
3.1 Medical device classifications (Act s 41DB)
3.2 Classification of medical devices
3.3 Principles for applying the classification rules
3.4 Conformity assessment procedures (Act s 41DA)
3.5 Medical devices manufactured outside Australia
3.6 Class III medical devices and Class AIMD medical devices (other than medical devices used for a special purpose)
3.7 Class IIb medical devices (other than medical devices used for a special purpose)
3.8 Class IIa medical devices (other than medical devices used for a special purpose)
3.9 Class I medical devices (other than medical devices used for a special purpose)
3.10 Medical devices used for a special purpose
3.11 Medical devices to which the clinical evaluation procedures must be applied
3.12 Records to be provided in English
3.13 Assessment or verification at intermediate stage of manufacture
4.1 When conformity assessment certificates are required (Act s 41EA)
4.2 Considering applications for conformity assessment certificates (Act s 41EC)
4.3 Time for making decision on applications (Act s 41ED, s 63 (2) (dc))
4.4 Period for revocation of suspension (Act s 41EP, s 63 (2) (db))
4.5 Application of Division 4.3
4.6 Death, bankruptcy or winding up of manufacturer
4.7 Disposal of business or amalgamation with another manufacturer
4.8 Change of name of manufacturer
4.9 Effect of conformity assessment certificate after transfer, etc
4.10 Notification to Secretary of events
4.11 Notification of change of name or suspension or revocation of conformity assessment certificate
5.2 Matters to be certified — period for obtaining information from manufacturer (Act s 41FD)
5.3 Applications to be selected for auditing (Act s 41FH)
5.4 Lapsing of applications — failure to pay assessment fee — specified period (Act s 41FK)
5.6 Conditions applying automatically — period for obtaining information from manufacturer (Act s 41FN)
5.7 Conditions applying automatically — period for giving information about adverse events etc (Act s 41FN)
5.8 Conditions applying automatically — requirements in relation to information about kind of medical device (Act s 41FN)
6.1 Period for revocation of suspension (Act s 41GD, s 63 (2) (dd))
7.1 Exempt devices — general (Act s 41HA)
7.2 Exempt devices — use in life-threatening cases (Act s 41HA)
7.3 Conditions of approval — use of device by person to whom approval is given (Act s 41HB)
7.4 Powers of authorised persons in relation to medical devices being used in clinical trials
7.5 Conditions of approval — use of device by another person (Act s 41HB)
7.6 Classes of medical practitioners and recipients (Act s 41HC)
7.7 Circumstances for supply of device under authority (Act s 41HC)
8.1 Notice period (Act s 41JA)
8.2 Exempt devices — statement by medical practitioner (Act s 41JD)
9.1 Fees
9.2 Application audit assessment fee (Act ss 41LA, 41LB)
9.3 Conformity assessment fee (Act ss 41LA, 41LB)
9.4 Conformity assessment fee — abridged assessment
9.5 Payment of assessment fee by instalments (Act s 41LC)
9.6 Reduction of assessment fees
9.7 Reduction of assessment fees — abridged assessment
10.1 Authorised persons
10.2 Imported medical devices — information about sponsor
10.3 Custom-made medical devices — information about manufacturer
10.4 Offences — period for notifying adverse events (Act s 41MP)
10.5 Delegation — powers and functions under these Regulations
10.6 Delegation — powers under paragraph 41HB (1) (d) of the Act
10.7 Review of decisions
- Schedule 1 Essential principles
  - Part 1 General principles
1 Use of medical devices not to compromise health and safety
2 Design and construction of medical devices to conform with safety principles
3 Medical devices to be suitable for intended purpose
4 Long-term safety
5 Medical devices not to be adversely affected by transport or storage
6 Benefits of medical devices to outweigh any side effects
- Part 2 Principles about design and construction
7 Chemical, physical and biological properties
8 Infection and microbial contamination
9 Construction and environmental properties
10 Medical devices with a measuring function
11 Protection against radiation
12 Medical devices connected to or equipped with an energy source
13 Information to be provided with medical devices
14 Clinical evidence
- Schedule 2 Classification rules
5.8 Medical devices intended for export only
5.9 Medical devices that are mammary implants
- Schedule 3 Conformity assessment procedures
- Schedule 4 Exempt devices
  - Part 1 Exempt devices — general
  - Part 2 Exempt devices — exemption subject to conditions
- Schedule 5 Fees
  - Part 1 General
  - Part 2 Additional fees
    - Dictionary
    - Notes to the REF Citation \*charformat Therapeutic Goods (Medical Devices) Regulations 2002

Therapeutic Goods (Medical Devices) Regulations 2002

Legislation text