Module 19 2021

01/06/2021

The big regulated markets - USA

Class III devices are highest risk (Pre-Market Approval) and need full audit as well as file review. Consensus standards are set such as ISO14971 and include CLSI for device performance criteria Clinical Study in US Instruments must meet 60601-1 (EU EMC/Safety OK) but are considered as Class I Mftr must have a FURLS registration of site and products UDI Requirements for Class II and III products

US agent required Costs $5k-$250K time 90 days to 2 years

23

The big regulated markets -Australia

Third biggest AP market after Japan and China Regulator is the Therapeutic Goods Agency (TGA) IVDs are regulated as IVD medical devices ● Four risk classifications A to D based on GHTF classification (D highest risk) Accept CE data and certification as proof of compliance Australian agent required Listing on the Australian Register of therapeutic Goods (ARTG) Annual fee required

24

12