Regulation of Medical Devices in Australia and New Zealand

| 01 February 2010

The Therapeutic Goods Administration (TGA) regulates the supply of medical devices in Australia according to criteria prescribed by the Therapeutic Goods Act of 1989 and related regulations.1,2 Since October 2002, the fundamental principles underlying medical device testing and assessment in Australia have been based on principles similar to those developed for the European Union that are part of a global harmonization approach through the Global Harmonization Task Force. However, the regulation of devices in Australia is unique in that an approval process resulting in the device's entry in the Australian Register of Therapeutic Goods (ARTG) must be followed.


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