Therapeutic Goods Act 1989
A plain English guide to the key parts of the Therapeutic Goods Act 1989 that apply to medical devices — the primary legislation underpinning all Australian medical device regulation.
Therapeutic Goods (Medical Devices) Regulations 2002
A guide to the structure and key content of the Therapeutic Goods (Medical Devices) Regulations 2002 — the primary subordinate legislation for Australian medical device regulation.
Related Instruments & Determinations
Legislative instruments, standards orders, and determinations made under the Therapeutic Goods Act 1989 that apply to medical devices in Australia.
How to Read Legislation
A practical guide to reading and navigating Australian Commonwealth legislation — including the Act, Regulations, and legislative instruments relevant to medical devices.
Recent Amendments
Significant amendments to Australian medical device legislation since 2020 — what changed, when it commenced, and what it means for sponsors and manufacturers.