EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 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. The Act is administered by the Therapeutic Goods Administration (the TGA) within the Australian Government Department of Health, Disability and Ageing (the Department).
Section 41BD of the Act sets out the meaning of ‘medical device’ for the purposes of the Act. Relevantly, paragraph 41BD(1)(a) of the Act 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). Those purposes include, for example, the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
Paragraph 41BD(1)(ab) of the Act provides that an instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection 41BD(2B), is also a medical device. Subsection 41BD(2B) of the Act provides that the Secretary may, by legislative instrument, specify a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles for the purposes of paragraph 41BD(1)(ab) of the Act.
The Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 (the Principal Instrument) is made under subsection 41BD(2B) of the Act. The Principal Instrument specifies a number of classes of instruments, apparatus, appliances, software, implants, reagents, materials and other articles to be medical devices for the purposes of the Act.
The Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025 (the Amendment Instrument) amends the Principal Instrument to specify seven additional classes of articles to be medical devices for the purposes of the Act. It also repeals and replaces Note 1 of section 4 to update the list of expressions used in the instrument that are defined in subsection 3(1) of the Act.
The Amendment Declaration includes a 5-year transition period for existing therapeutic goods which are registered goods or listed goods whose regulatory status is changed by the Amendment Instrument, to allow sponsors of such products sufficient time to transition their products to regulation under Chapter 4 of the Act as medical devices.
Background
Paragraph 41BD(1)(ab) of the Act provides that an instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection 41BD(2B), is also a medical device. Subsection 41BD(2B) of the Act provides that the Secretary may, by legislative instrument, specify a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles for the purposes of paragraph 41BD(1)(ab) 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’ that principally comprise tampons, menstrual cups and certain kinds of disinfectants. Some goods, known as boundary products, may have attributes of two or more of these regulatory categories, with the effect that the appropriate regulatory pathway for such products is not immediately clear. Similarly, combination products can contain two or more type of therapeutic goods, with multiple therapeutic actions or effects. The effect of the Amendment Instrument is that seven new classes of goods are specified to be medical devices for the purposes of the Act.
Purpose
The Principal Instrument is made under subsection 41BD(2B) of the Act. The Principal Instrument specifies that particular classes of instruments, apparatus, appliances, materials or other articles are medical devices for the purposes of the Act.
The effect of an instrument made under subsection 41BD(2B) of the Act is that particular classes of instruments, apparatus, appliances, software, implants, reagents, materials or other articles are specified to be medical devices and therefore subject to regulation under Chapter 4 of the Act.
Chapter 4 includes regulatory requirements that are appropriate for medical devices, including requirements for conformity assessment certification for quality management systems and compliance with the essential principles. However, there may be uncertainty as to whether certain therapeutic goods are or are not medical devices for the purposes of the Act. An instrument under subsection 41BD(2B) is principally designed to provide clarity on the correct regulatory arrangements that apply to particular goods.
The Amendment Instrument is made under subsection 41BD(2B) and adds seven new items to the table in Schedule 1 to the Principal Instrument, with the effect that these items will be medical devices for the purposes of the Act:
- New table item 8 specifies locking solutions to be used in vascular access devices, that are intended to be used solely to maintain the patency of the device.
- New table item 9 specifies products that are generated by ozone generators which are intended to be used for sanitising or disinfecting a medical device or medical equipment, or the cleaning of the oral cavity.
- New table item 10 specifies pre-filled saline flush syringes where the only intended purpose is maintaining the patency or flushing the lumen of a medical device.
- New table item 11 specifies weight loss treatments that are ingested into the body and that achieve their principal intended action only through physical means. This includes, for example, capsules that expand in the stomach to create a feeling of satiety.
- New table item 12 specifies head or body lice treatments that achieve their principal intended action only by means of physical action. This includes, for example, products that coat the hair shaft to prevent lice/egg attachment.
- New table item 13 specifies toothpastes (and other dentifrices) that achieve their principal intended action only by means of physical action. This includes, for example, products that block the dental tubules to reduce/treat sensitivity.
- New table item 14 specifies moisturisers and emollients that achieve their principal intended action only by means of physical action. This includes, for example, products that act as a barrier.
Specifying that these boundary products are medical devices serves to clarify the regulatory requirements for these products, assisting sponsors and manufacturers to understand and meet applicable requirements under the Act. The changes to the regulatory status of these products are also designed to better align with comparable international jurisdictions, and to provide clarity for new products entering the market.
The 5-year transitional period for these changes is designed to allow sufficient time for manufacturers of the affected products to make the necessary adjustments to meet applicable regulatory requirements.
Consultation
Two public consultations were undertaken in relation to the proposals reflected in the Amendment Instrument – one in 2022, and another 2024.
The consultation undertaken in 2022 sought feedback on draft guidance prepared by the TGA for the regulation of boundary and combination products. Feedback on that consultation suggested that further clarity was needed in relation to certain boundary and combination products.
A second consultation was undertaken in 2024 in relation to the most appropriate regulatory pathway for a number of boundary and combination products, including the products affected by the Amendment Instrument. The TGA received 34 responses to the consultation, with overall support for the approach reflected in the Amendment Instrument. A proposed 5-year transitional period was also supported.
Other details
Details of the Amendment Instrument are set out in Attachment A.
The Amendment Instrument 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 Instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on 1 January 2026.
Attachment A
Details of the Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025
Section 1 – Name
This section provides that the name of the instrument is Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025 (the Amendment Instrument).
Section 2 – Commencement
This section provides that the Amendment Instrument commences on 1 January 2026.
Section 3 – Authority
This section provides that the legislative authority for making the Amendment Instrument is subsection 41BD(2B) 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 Instrument 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 Instrument 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 Instrument has effect according to its terms.
Schedule 1 – Amendments
This Schedule amends the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 (the Principal Instrument).
Item 1 – Section 4 (note)
This item repeals the existing Note 1 in section 4, which provides a list of expressions used in the instrument that are defined in subsection 3(1) of the Act, and replaces it with a new Note 1 that reflects a number of new expressions added to the instrument by the Amendment Instrument.
Item 2 – after section 5
This item inserts new section 6 to the Principal Instrument, which provides for application, savings and transitional provisions relating to the amendments made by the Amendment Instrument. The effect of this section is to provide for a 5-year transitional period for existing therapeutic goods whose regulatory category is changed by the Amendment Declaration. Products that were registered goods or listed goods immediately prior to the commencement of the Amendment Instrument will not be subject to the specification that they are medical devices for a period of 5 years, ending 1 January 2031. During this period, they will continue to be regulated under their existing regulatory category until such time as their sponsors complete the necessary process for the goods to be regulated as medical devices. However, to assist this process, new section 6 provides for the affected goods to treated as medical devices for the purposes of the application process and the associated provisions of the Act.
Item 3 - Schedule 1 (at the end of the table)
Item 3 inserts new items 8 to 14 in Schedule 1 to the Principal Instrument.
New item 8 specifies products that are locking solutions to be used in vascular access devices that are intended to be used solely to maintain the patency of the device.
New item 9 specifies products that are generated by ozone generators which are intended to be used for sanitising or disinfecting a medical device or medical equipment, or the cleaning of the oral cavity, to be medical devices for the purposes of the Act.
New item 10 specifies products that are pre-filled saline flush syringes where the only intended purpose is maintaining the patency or flushing the lumen of a medical device to be medical devices for the purposes of the Act.
New item 11 specifies products that are weight loss treatments that are ingested into the body and that achieve their principal intended action only through physical means to be medical devices for the purposes of the Act. This includes, for example, capsules that expand in the stomach to create a feeling of satiety.
New item 12 specifies head or body lice treatments that achieve their principal intended action only by means of physical action to be medical devices for the purposes of the Act.
New item 13 specifies toothpastes (and other dentifrices) that achieve their principal intended action only by means of physical action to be medical devices for the purposes of the Act.
New item 14 specifies moisturisers and emollients that achieve their principal intended action only by means of physical action to be medical devices for the purposes of the Act.
Attachment B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 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 sets out the meaning of ‘medical device’ for the purposes of the Act. Relevantly, paragraph 41BD(1)(a) of the Act 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). Those purposes include, for example, the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
Paragraph 41BD(1)(ab) of the Act provides that an instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection 41BD(2B), is also a medical device. Subsection 41BD(2B) of the Act provides that the Secretary may, by legislative instrument, specify a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles for the purposes of paragraph 41BD(1)(ab) of the Act.
The Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 (the Principal Instrument) is made under subsection 41BD(2B) of the Act. The Principal Instrument specifies a number of classes of instruments, apparatus, appliances, software, implants, reagents, materials and other articles to be medical devices for the purposes of the Act.
The Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025 (the Amendment Instrument) amends the Principal Instrument to specify seven additional classes of articles to be medical devices for the purposes of the Act. It also repeals and replaces Note 1 of section 4 to update the list of expressions used in the instrument that are defined in subsection 3(1) of the Act.
The Amendment Declaration includes a 5-year transition period for existing therapeutic goods which are registered goods or listed goods whose regulatory status is changed by the Amendment Instrument, to allow sponsors of such products sufficient time to transition their products to regulation under Chapter 4 of the Act as medical devices.
Background
Paragraph 41BD(1)(ab) of the Act provides that an instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection 41BD(2B), is also a medical device. Subsection 41BD(2B) of the Act provides that the Secretary may, by legislative instrument, specify a particular class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles for the purposes of paragraph 41BD(1)(ab) 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’ that principally comprise tampons, menstrual cups and certain kinds of disinfectants. Some goods, known as boundary products, may have attributes of two or more of these regulatory categories, with the effect that the appropriate regulatory pathway for such products is not immediately clear. Similarly, combination products can contain two or more type of therapeutic goods, with multiple therapeutic actions or effects. The effect of the Amendment Instrument is that seven new classes of goods are specified to be medical devices for the purposes of the Act.
Purpose
The Principal Instrument is made under subsection 41BD(2B) of the Act. The Principal Instrument specifies that particular classes of instruments, apparatus, appliances, materials or other articles are medical devices for the purposes of the Act.
The effect of an instrument made under subsection 41BD(2B) of the Act is that particular classes of instruments, apparatus, appliances, software, implants, reagents, materials or other articles are specified to be medical devices and therefore subject to regulation under Chapter 4 of the Act.
Chapter 4 includes regulatory requirements that are appropriate for medical devices, including requirements for conformity assessment certification for quality management systems and compliance with the essential principles. However, there may be uncertainty as to whether certain therapeutic goods are or are not medical devices for the purposes of the Act. An instrument under subsection 41BD(2B) is principally designed to provide clarity on the correct regulatory arrangements that apply to particular goods.
The Amendment Instrument is made under subsection 41BD(2B) and adds seven new items to the table in Schedule 1 to the Principal Instrument, with the effect that these items will be medical devices for the purposes of the Act:
- New table item 8 specifies locking solutions to be used in vascular access devices, that are intended to be used solely to maintain the patency of the device.
- New table item 9 specifies products that are generated by ozone generators which are intended to be used for sanitising or disinfecting a medical device or medical equipment, or the cleaning of the oral cavity.
- New table item 10 specifies pre-filled saline flush syringes where the only intended purpose is maintaining the patency or flushing the lumen of a medical device.
- New table item 11 specifies weight loss treatments that are ingested into the body and that achieve their principal intended action only through physical means. This includes, for example, capsules that expand in the stomach to create a feeling of satiety.
- New table item 12 specifies head or body lice treatments that achieve their principal intended action only by means of physical action. This includes, for example, products that coat the hair shaft to prevent lice/egg attachment.
- New table item 13 specifies toothpastes (and other dentifrices) that achieve their principal intended action only by means of physical action. This includes, for example, products that block the dental tubules to reduce/treat sensitivity.
- New table item 14 specifies moisturisers and emollients that achieve their principal intended action only by means of physical action. This includes, for example, products that act as a barrier.
Specifying that these boundary products are medical devices serves to clarify the regulatory requirements for these products, assisting sponsors and manufacturers to understand and meet applicable requirements under the Act. The changes to the regulatory status of these products are also designed to better align with comparable international jurisdictions, and to provide clarity for new products entering the market.
The 5-year transitional period for these changes is designed to allow sufficient time for manufacturers of the affected products to make the necessary adjustments to meet applicable regulatory requirements.
Human rights implications
The Amendment Instrument engages the right to health in Article 12 of the International Covenant on Economic, Social and Cultural rights (the ICESCR). Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standards of physical and mental health and includes an obligation to take reasonable measures within available resources to progressively secure broader enjoyment of the right.
The Amendment Declaration supports the right to health by clarifying the regulatory status of a number of categories of product about which there has been some confusion or concern as to which is the appropriate regulatory pathway for them. The effect of the Amendment Declaration is to reduces the risk of confusion and provide greater certainty for sponsors, manufacturers, health practitioners and patients, improving understanding and compliance with the regulatory scheme and supporting the safe use of therapeutic goods in Australia.
Conclusion
The Amendment Instrument is compatible with human rights because it promotes the right to health in Article 12 of the ICESCR and otherwise does not raise any other human rights issues.