TGA - Australia Therapeutic Goods Administration

The Therapeutic Goods Administration is the Australian regulatory for therapeutic goods such as pharmaceuticals, blood products and tissues or medical devices. It also ensures access to new therapeutic goods for the population and protects public health though the Therapeutic Goods Act 1989 (the Act). The TGA is a division of the Australian Department of Health and Ageing, part of the Department of Health.

In matters of medical device safety, quality and performance, the TGA is advised by Advisory Committee on Medical Devices (ACMD), formerly known as the Medical Device Evaluation Committee (MDEC). This committee also oversees premarket conformity assessment and post market monitoring of medical devices.

Major Regulations

Some of the most important regulations for medical devices in Australia are:

A full list of TGA regulations can be found here.

Contact details:

Medical Device Associations in Australia: