Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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

The Organisation for Professionals in Regulatory Affairs

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The big regulated markets -Brazil

 Regulator is ANVISA  IVDs are regulated as IVD medical devices ● Four risk classifications I,II and III and IV  Class I/II use Cadastro registration route low risk submission  Class III/IV use the Registro route and require GMP inspection of site (Changing to MDSAP process)  Brazilian agent required  Labelling in Brazillian Portuguese/Date format DD-MM-YYYY  Cost $5K new and renewal but audits much more  CE data can be used.

The Organisation for Professionals in Regulatory Affairs

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