Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026

Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026

made under subsections 41HD(5) and 41HD(6) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date: 1 May 2026

Includes amendments: F2026L00492

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026 that shows the text of the law as amended and in force on 1 May 2026 (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If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.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

2  Commencement

3  Authority

4  Definitions

5  Medical devices—foreign countries and specified devices

Schedule 1—Foreign countries

Schedule 2—Specified medical devices

Part 1—Medical devices other than IVD medical devices

Part 2—Medical devices that are IVD medical devices

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 (Medical Devices—Foreign Countries) Determination 2026.

2  Commencement

 (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under subsections 41HD(5) and 41HD(6) 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) medical device.

  In this instrument:

Act means the Therapeutic Goods Act 1989.

Class 1 IVD medical device has the same meaning as in the MD Regulations.

Class 2 IVD medical device has the same meaning as in the MD Regulations.

Class 3 IVD medical device has the same meaning as in the MD Regulations.

Class 4 IVD medical device has the same meaning as in the MD Regulations.

Class I medical device has the same meaning as in the MD Regulations.

Class IIa medical device has the same meaning as in the MD Regulations.

Class IIb medical device has the same meaning as in the MD Regulations.

Class III medical device has the same meaning as in the MD Regulations.

IVD medical device has the same meaning as in the MD Regulations.

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

5  Medical devices—foreign countries and specified devices

 (1) The countries specified in Schedule 1 are foreign countries for the purposes of subparagraph 41HD(1)(d)(i) of the Act.

 (2) The medical devices specified in Part 1 and Part 2 of Schedule 2 are medical devices that can be the subject of an approval under section 41HD of the Act.

Schedule 1—Foreign countries

Note: See subsection 5(1).

Schedule 2—Specified medical devices

Note: See subsection 5(2).

Part 1—Medical devices other than IVD medical devices

Part 2—Medical devices that are IVD medical devices

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