Legislation

To read the full text, visit the Federal Register of Legislation.

This Specification facilitates the release of specified therapeutic goods information, relating to in-house in vitro diagnostic (IVD) medical devices, to the National Association of Testing Authorities (NATA).

This Specification facilitates the release of specified therapeutic goods information held by the TGA in the database known as the Database of Recalls, Product Alerts and Product Corrections (DRAC), relating to market actions involving therapeutic goods.

This Specification facilitates the public release of specified therapeutic goods information.

This Instrument authorises the public release of specified therapeutic goods information that has been reported to the TGA and is recorded in the Database of Adverse Event Notifications (DAEN).

This Instrument authorises the release of specified therapeutic goods information relating to medicine shortages and availability data either to a specified person, body or authority or to the public.

This legislation specifies information requirements for therapeutic vaping products and devices in Australia for regulatory and safety purposes.

This amendment to the Therapeutic Goods Regulations 1990 makes various changes to support the implementation of the TGA’s Medicines Repurposing Program (MRP), and a small number of other measures.

The Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 introduces the Unique Device Identification (UDI) system in Australia.

This Instrument amends the Therapeutic Goods Regulations 1990 to increase fees relating to therapeutic goods to support cost recovery.

The Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024 is a significant amendment to the Therapeutic Goods Act 1989 in Australia.

These Amendment Regulations amend the Therapeutic Goods Regulations 1990 and Therapeutic Goods (Medical Devices) Regulations 2002 to implement the first stage of the Government's vaping reform measures.

This Specification specifies therapeutic goods information that may be released by the Secretary in relation to compliance reviews of listed medicines.

This Determination sets out conditions for listing specified listed medicines on the Australian Register of Therapeutic Goods (ARTG).

This legislation updates the requirements for the manufacturing of therapeutic goods in Australia to ensure compliance with minimum benchmarks and to ensure the safety and quality of therapeutic goods manufactured in Australia.

This Determination sets legally enforceable standards to ensure therapeutic goods in Australia are manufactured safely, consistently, and to high quality.

The Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Amendment Order 2024 establishes quality and safety requirements for therapeutic vaping devices in Australia.

This Order constitutes an optional medical device standard for therapeutic vaping devices and therapeutic vaping device accessories.

The Therapeutic Goods (Medical Devices) Regulations 2002 set out the requirements for the registration, classification, and conformity assessment of medical devices in Australia. 

These Rules specify circumstances in which a health practitioner is authorised to supply specified medical devices which are not included in the Australian Register of Therapeutic Goods (ARTG), under the TGA's Special Access Scheme category C pathway.

This exemption applies to medical devices used for donor screening in response to the COVID-19 pandemic.

The Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020 outlines the specific categories of therapeutic goods that are excluded from the operation of the Therapeutic Goods Act 1989 (Cth).

This Specification specifies kinds of medical devices that cannot be approved for marketing in Australia if they are intended to be used exclusively for one or more specified purposes.

This Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).

This Instrument amends the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 to specify certain articles and components for use in the manufacture of therapeutic vaping devices or their accessories that are medical devices for the purposes of the Therapeutic Goods Act 1989.