RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > Regulation of Medical Devices in Australia and New Zealand

Regulation of Medical Devices in Australia and New Zealand

Posted 01 February 2010 | By

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.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe

Regulatory Focus™ is doing essential, non-biased journalism during this unprecedented time. We appreciate your support as we bring you the news and intelligence you need to make an impact on global healthcare.

Regulatory Focus™ provides the intelligence you need to impact global healthcare during this crisis. Thank you for your support.