Therapeutic Goods Act 1989 (Australia)

The Therapeutic Goods Act 1989 is the primary legislative framework for regulating the quality, safety, efficacy, and availability of therapeutic goods in Australia. It governs a wide range of products including medicines, medical devices, biologicals, and vaping goods. The Act is regularly amended and is enforced by the Therapeutic Goods Administration (TGA), Australia’s medical device regulatory authority.

The Act established the Australian Register of Therapeutic Goods (ARTG), which is a database maintained by the Secretary of the Department of Health. Therapeutic goods must be included in the ARTG, or be exempt or approved under specific provisions, before they can be lawfully imported, exported, manufactured, or supplied in Australia.

What does the Therapeutic Goods Act 1989 establish?

Key features of the Act include:

• A risk-based regulatory system for therapeutic goods, with varying levels of scrutiny depending on the product type and classification.

• Distinct regulatory pathways for medicines (registered or listed), biologicals, and medical devices, each with specific requirements for approval and post-market oversight.

• Manufacturing licensing and Good Manufacturing Practice (GMP) requirements to ensure product quality.

• Advertising controls, including prohibitions on misleading claims and requirements for compliance with the Therapeutic Goods Advertising Code.

• Robust compliance and enforcement protocols that combine criminal offences, civil penalties, inspection powers, and product recalls.

How does the Act work with other Australian rules?

The Act operates alongside the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002, and relevant State and Territory laws and provides mechanisms for emergency exemptions, special use approvals, and regulatory oversight throughout the product lifecycle.

Read the Therapeutic Goods Act 1989.

Why does the Act matter to overseas medical device manufacturers?

The Act is the legal foundation for inclusion in the ARTG, sponsor responsibilities, compliance powers and post-market action. An overseas manufacturer normally works through an Australian sponsor, but the manufacturer's evidence must still support the applicable conformity assessment and registration route. See the Australia market guide for the operational pathway.