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Therapeutic Goods (Medical Devices) Regulations 2002

Statutory Rules No. 236, 2002
made under the

Therapeutic Goods Act 1989

Compilation No. 66

Compilation date: 14 December 2024

                Includes amendments: F2024L01673

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Medical Devices) Regulations 2002 that shows the text of the law as amended and in force on 14 December 2024 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

Contents
Part 1—Preliminary
1.1 Name of Regulations
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))
1.8 Classes of persons that are not manufacturers of a medical device
Part 2—Essential principles
2.1 Essential principles (Act s 41CA)
Part 3—Conformity assessment procedures
Division 3.1—Medical device classifications
3.1 Medical device classifications (Act s 41DB)
3.2 Classification of medical devices
3.3 Principles for applying the classification rules
Division 3.2—Conformity assessment procedures
3.4 Conformity assessment procedures (Act s 41DA)
3.5 Powers and functions of Secretary in relation to conformity assessment
3.6 Class III medical devices (other than medical devices used for a special purpose)
3.6A Class 4 IVD medical devices (other than medical devices to be used for a special purpose)
3.6B Class 4 in‑house IVD medical devices (other than medical devices to be used for a special