Australian market access

Therapeutic Goods Regulations (TGR) of Australia

Australia market accessThe Therapeutic Goods Regulations (TGR) of Australia defines the country’s requirements for medical device certification. And in order to achieve TGR certification, medical device manufacturers must undergo conformity assessments performed by a recognized body such as BSI. The Australian Therapeutic Goods Administration (TGA) also recognizes European CE marking, so some manufacturers will already be closer to achieving compliance for entering the Australian market.