TGA (Therapeutic Goods Administration)

The Therapeutic Goods Administration (TGA) is Australia's federal regulatory authority responsible for overseeing prescription and over-the-counter medicines, vaccines, biologicals, medical devices, sunscreens, vitamins and minerals, blood and blood products, and certain diagnostic tests. The TGA functions within the Department of Health and Aged Care and operates under the Therapeutic Goods Act 1989, which mandates that most therapeutic products must be registered, listed, or included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied, imported, exported, or manufactured in Australia.

The regulation of medical devices within the TGA is overseen by the Medical Devices and Product Quality Division, with responsibilities shared between two specialized branches. The Medical Devices Authorisation Branch (MDAB) handles pre-market activities including applications for ARTG inclusion of medical devices and in vitro diagnostic devices (IVDs), conformity assessment, medical device regulation reforms, and clinical and medical advice. The Medical Devices Surveillance Branch (MDSB) manages post-market monitoring including adverse event reporting, quality audits and assessments, post-market reforms and reviews, emerging technology policy and reform (including IVD reform), and unique device identification.

The TGA evaluates and assesses medical devices pre-market to establish safety, quality, and efficacy before granting inclusion in the ARTG. Following approval, the TGA monitors the market through adverse event surveillance, recalls, safety alerts, and compliance inspections. It also regulates manufacturing practices and enforces advertising standards.

Website: Australia TGA
Address: TGA, PO Box 100, Woden ACT 2606, Australia
Phone: +61 2 6289 4124
Email: Contact form