Therapeutic Goods (Overseas Regulators) Determination 2018

made under subsection 41BIB(2) of the

Therapeutic Goods Act 1989

Compilation No. 3

Compilation date: 1 December 2025

Includes amendments: F2025N00863

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Overseas Regulators) Determination 2018 that shows the text of the law as amended and in force on 1 December 2025 (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. The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au).

Application, saving and transitional provisions

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.

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. Any modifications affecting the law are accessible on the Register.

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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

1  Name

3  Authority

4  Definitions

5  Overseas regulators

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

1  Name

  This instrument is the Therapeutic Goods (Overseas Regulators) Determination 2018.

3  Authority

  This instrument is made under subsection 41BIB(2) of the Therapeutic Goods Act 1989.

4  Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) overseas regulator;

(b) medical device.

In this instrument:

Act means Therapeutic Goods Act 1989.

active implantable medical device has the same meaning as in the Regulations.

IAF accredited conformity assessment body means a body that is accredited to undertake certification for compliance with ISO 13485 by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.

in vitro diagnostic medical device has the same meaning as in the Regulations.

ISO 13485 means International Standard ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, issued by the International Organization for Standardization in March 2016, as in force or existing immediately before the commencement of this instrument.

Note: ISO 13485 is published at: https://www.iso.org.

notified body means a body that has been designated by a member state of the European Union, and notified to the European Commission, to assess the conformity of medical devices, including in vitro diagnostic medical devices and active implantable medical devices.

recognised or authorised auditing organisation means an organisation that is recognised or authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council in relation to that program, comprising Australia’s Therapeutic Goods Administration, the United States Food and Drug Administration, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency.

Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

UK approved body has the meaning given to “approved body” in regulation A45 of the UK Regulations.

UK Regulations means the Medical Devices Regulations 2002 (SI 2002/618), as in force in England, Wales and Scotland on 1 December 2025.

Note: The UK Regulations could in 2025 be viewed on the UK legislation website (www.legislation.gov.uk).

5  Overseas regulators

  Each of the following is determined to be an overseas regulator for the purposes of subsection 41BIB(1) of the Act:

 (a) an IAF accredited conformity assessment body;

 (b) a notified body;

 (c) a recognised or authorised auditing organisation;

 (d) Health Canada;

 (e) Health Sciences Authority of Singapore;

 (f) Japan’s Ministry of Health, Labour and Welfare;

 (g) the Japanese Pharmaceuticals and Medical Devices Agency;

 (h) the United States Food and Drug Administration;

 (i) a UK approved body.

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe how an amendment is to be made. If, despite the misdescription, the amendment can be given effect as intended, then the misdescribed amendment can be incorporated through an editorial change made under section 15V of the Legislation Act 2003.

If a misdescribed amendment cannot be given effect as intended, the amendment is not incorporated and “(md not incorp)” is added to the amendment history.

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history