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.
Some of the most important regulations for medical devices in Australia are:
- Summary of Therapeutic Goods Act 1989
- Therapeutic Goods Amendment Regulations 2010
- Therapeutic Goods (Medical Devices) Amendment Regulations 2010
A full list of TGA regulations can be found here.
- Website: https://www.tga.gov.au/
Medical Device Associations in Australia: