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 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.

When was TGA established?

TGA began operations in 1990 to enforce the requirements of the Therapeutic Goods Act 1989. It evolved from the Australia Therapeutics Division.

What primary device regulations does TGA enforce?

TGA enforces the Therapeutic Goods Act of 1989, the primary legislation governing therapeutic goods in Australia. It established the system and requirements for ensuring the safety and efficacy of therapeutic goods. The Therapeutic Goods (Medical Devices) Regulations 2002 governs the safety and performance of medical devices specifically, including software and IVDs, and established the requirements for inclusion in the ARTG.

How is TGA funded?

The TGA is mostly self-supporting through its fee structure. It charges fees for certain activities, such as mandatory application audits and annual fees for ARTG listings.

How can I contact TGA?

You can contact TGA in writing via their contact form (recommended for more complex inquiries) or by phone, Monday to Friday, 9:00 am to 5:00 pm (except holidays):

• Toll free within Australia: 1 800 020 653
• Outside Australia: +61 2 6289 4124

To report a medical device adverse event, follow the directions on the TGA website.

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