Medical Device and Pharmaceuticals Regulatory Affairs and Quality Consulting for Australia
Australia, with 22 million residents, is the third-largest device market in the Asia Pacific region – after Japan and China.
|Australia Medical Device Market Size||Australia Pharmaceutical Market Size|
|$11.8 billion||$22.7 billion|
|Projected Growth Rate: 6%||Projected Growth Rate: 5.1%|
|Australia Economic Indicators|
|GDP (PPP): $1.56 trillion|
|Per Capita GDP (PPP): $42,450|
|Real GDP Growth Rate: 2.5%|
|Population (millions): 23.13|
|Ethnic Diversity: English 25.9% , Dutch 1.2% etc.|
The Therapeutic Goods Administration (TGA) is the unit of the Australian government’s Department of Health and Aging that oversees medical device regulation in Australia.
Before selling any medical devices in Australia, they must first be included in the Australian Register of Therapeutic Goods (ARTG) which is regulated by the Australian Therapeutic Goods Administration (TGA) and be registered as well.
The registering pathway for medical devices with the TGA depends on their risk classification compliance with quality, safety and performance principles; compliance with regulatory controls for manufacturing processes; listing in the Australian Register of Therapeutic Goods; and post-market vigilance programs. For more information, check the TGA website at : https://www.tga.gov.au/
Devices that have already earned CE certification from European Notified Bodies can be easily substantiate conformity to TGA requirements. Manufacturers must also provide Declarations of Conformity to the Australian Regulations to register with the TGA.