EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 3) 2025
The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in, or exported from, Australia. It also provides for the establishment and maintenance of a national system of controls for the importation, manufacture, supply, commercial possession, advertising and export of vaping goods. The Act is administered by the Therapeutic Goods Administration (the TGA) within the Australian Government Department of Health, Disability and Ageing.
Section 41BD of the Act provides the meaning of ‘medical device’ for the purposes of the Act. Relevantly paragraph 41BD(1)(a) provides that a medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article that is intended, by the person under whose name it is, or is to be, supplied, to be used for human beings for one or more of the purposes in subparagraphs 41BD(1)(a)(i) to (v) and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means. Those purposes include, for example, the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
Subsection 41BD(3) of the Act provides that the Secretary may, by legislative instrument, declare that a particular instrument, apparatus, appliance, software, implant, reagent, material or other article, or a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles, are not medical devices for the purposes of the Act.
A declaration under subsection 41BD(3) does not prevent articles from being therapeutic goods. That is, if an article is declared not to be a medical device, but otherwise meets the definition of ‘therapeutic goods’ in subsection 3(1) of the Act, the article will be regulated as such under Chapter 3 of the Act, rather than as a medical device under Chapter 4 of the Act.
The Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 (the Principal Declaration) is a legislative instrument made under subsection 41BD(3) of the Act, and declares that a number of articles are not medical devices for the purposes of the Act.
The Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 3) 2025 (the Amendment Declaration) amends the Principal Declaration to correct the item numbers of items that were introduced by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025, and the references to those items in the application, saving and transitional provision. The item numbers of the new items are 8 to 11 in error, and should instead be items 13 to 16. The Amendment Declaration makes this correction, and consequential corrections to the application, saving and transitional provision.
Background
Subsection 41BD(3) of the Act provides that the Secretary may, by legislative instrument, declare that a particular instrument, apparatus, appliance, software, implant, reagent, material or other article, or a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles, are not medical devices for the purposes of the Act.
Products that meet the legislative definition of a therapeutic good under the Act are regulated by the TGA and, unless exempt, are required to be included in the Australian Register of Therapeutic Goods (the ARTG).
The main categories of therapeutic goods are medicines, medical devices, biologicals and a category known as ‘other therapeutic goods’ which principally comprises tampons, menstrual cups and certain kinds of disinfectants. Some goods, known as boundary products, have attributes of two or more of these regulatory categories, and as a result the appropriate regulatory pathway for such products is not immediately clear. Similarly, combination products contain two or more type of therapeutic goods with multiple therapeutic actions or effects.
The Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 clarifies the regulatory status of four classes of such boundary products. It is made under subsection 41BD(3) of the Act and adds four new items to the table in Schedule 1 to the Principal Declaration, with the effect that products covered by these items will not be medical devices for the purposes of the Act. This instrument also introduces a 5-year transitional period for these changes to allow a sufficient time for manufacturers of the affected products to make the necessary adjustments to meet applicable regulatory requirements.
Purpose
Items 8 to 11 in Schedule 1 to the Principal Instrument, as introduced by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025, contain incorrect item number references. These items should instead be numbered 13 to 16 as the table in Schedule 1 to the Principal Instrument already has items up to item 12.
The Amendment Declaration amends the table items that were introduced by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 to correct this error and replace the item numbers with the correct item numbers.
The Amendment Declaration also makes consequential corrections to section 6 which was also introduced by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 and refers to the incorrect item numbers. The amendments made to section 6 by the Amendment Declaration preserve the effect of the transitional arrangements in light of the corrections to the item numbers.
The Amendment Declaration commences immediately after the commencement of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 to effect an immediate correction.
Consultation
Consultation was not undertaken because the purpose of the Amendment Declaration is simply to correct an inadvertent error in the numbering of item numbers. The amendments do not change the effect of the Principal Instrument. Consultation was undertaken in relation to the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025.
Other details
Details of the Amendment Declaration are set out in Attachment A.
The Amendment Declaration is compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.
The Amendment Declaration is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences immediately after the commencement of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 on 1 January 2026.
Attachment A
Details of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 3) 2025
Section 1 – Name
This section provides that the name of the instrument is the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 3) 2025 (the Amendment Declaration).
Section 2 – Commencement
This section provides that the Amendment Declaration commences immediately after the commencement of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025, on 1 January 2026.
Section 3 – Authority
This section provides that the legislative authority for making the Amendment Declaration is subsection 41BD(3) of the Therapeutic Goods Act 1989 (the Act).
Subsection 33(3) of the Acts Interpretation Act 1901 relevantly provides that, where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character, the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument. The Amendment Declaration is made in accordance with that provision.
Section 4 – Schedules
This section provides that each instrument that is specified in a Schedule to the Amendment Declaration is amended or repealed as set out in the applicable items in the Schedule concerned, and that any other item in a Schedule to the Amendment Declaration has effect according to its terms.
Schedule 1 – Amendments
This Schedule amends the Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 (the Principal Declaration).
Items 1 to 4 – Section 6
These items amend section 6 of the Principal Declaration, which is the application, saving and transitional provision, to replace references to incorrect item numbers with references to correct item numbers as amended by the Amendment Declaration. Where appropriate, these items also remove references to the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 in section 6 in order to preserve the effect of the provision.
Items 5 to 8 – Schedule 1 (table)
These items replace the item numbers for items 8 to 11 (second occurring), as introduced by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025, to give these items the correct item numbers from 13 to 16.
Attachment B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 3) 2025
This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of legislative instrument
Section 41BD of the Act provides the meaning of ‘medical device’ for the purposes of the Act. Relevantly paragraph 41BD(1)(a) provides that a medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article that is intended, by the person under whose name it is, or is to be, supplied, to be used for human beings for one or more of the purposes in subparagraphs 41BD(1)(a)(i) to (v) and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means. Those purposes include, for example, the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
Subsection 41BD(3) of the Act provides that the Secretary may, by legislative instrument, declare that a particular instrument, apparatus, appliance, software, implant, reagent, material or other article, or a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles, are not medical devices for the purposes of the Act.
A declaration under subsection 41BD(3) does not prevent articles from being therapeutic goods. That is, if an article is declared not to be a medical device, but otherwise meets the definition of ‘therapeutic goods’ in subsection 3(1) of the Act, the article will be regulated as such under Chapter 3 of the Act, rather than as a medical device under Chapter 4 of the Act.
The Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 (the Principal Declaration) is a legislative instrument made under subsection 41BD(3) of the Act, and declares that a number of articles are not medical devices for the purposes of the Act.
The Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 3) 2025 (the Amendment Declaration) amends the Principal Declaration to correct the item numbers of items that were introduced by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025, and the references to those items in the application, saving and transitional provision. The item numbers of the new items are 8 to 11 in error, and should instead be items 13 to 16. The Amendment Declaration makes this correction, and consequential corrections to the application, saving and transitional provision.
Background
Subsection 41BD(3) of the Act provides that the Secretary may, by legislative instrument, declare that a particular instrument, apparatus, appliance, software, implant, reagent, material or other article, or a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles, are not medical devices for the purposes of the Act.
Products that meet the legislative definition of a therapeutic good under the Act are regulated by the TGA and, unless exempt, are required to be included in the Australian Register of Therapeutic Goods (the ARTG).
The main categories of therapeutic goods are medicines, medical devices, biologicals and a category known as ‘other therapeutic goods’ which principally comprises tampons, menstrual cups and certain kinds of disinfectants. Some goods, known as boundary products, have attributes of two or more of these regulatory categories, and as a result the appropriate regulatory pathway for such products is not immediately clear. Similarly, combination products contain two or more type of therapeutic goods with multiple therapeutic actions or effects.
The Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 clarifies the regulatory status of four classes of such boundary products. It is made under subsection 41BD(3) of the Act and adds four new items to the table in Schedule 1 to the Principal Declaration, with the effect that products covered by these items will not be medical devices for the purposes of the Act. This instrument also introduces a 5-year transitional period for these changes to allow a sufficient time for manufacturers of the affected products to make the necessary adjustments to meet applicable regulatory requirements.
Purpose
Items 8 to 11 in Schedule 1 to the Principal Instrument, as introduced by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025, contain incorrect item number references. These items should instead be numbered 13 to 16 as the table in Schedule 1 to the Principal Instrument already has items up to item 12.
The Amendment Declaration amends the table items that were introduced by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 to correct this error and replace the item numbers with the correct item numbers.
The Amendment Declaration also makes consequential corrections to section 6 which was also introduced by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 and refers to the incorrect item numbers. The amendments made to section 6 by the Amendment Declaration preserve the effect of the transitional arrangements in light of the corrections to the item numbers.
The Amendment Declaration commences immediately after the commencement of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025 to effect an immediate correction.
Human rights implications
As the Amendment Declaration simply corrects an error in the numbers assigned to new items in the table in the Schedule to the Principal Declaration, as well as other references to those incorrect item numbers, the Amendment Declaration does not engage any applicable rights or freedoms.
Conclusion
The Amendment Declaration is compatible with human rights because it does not raise any human rights issues.