Module 19: Regulation of In Vitro Diagnostic Medical Devices

20/04/2023

 Pre-submission process is available  Construction of Technical Documentation follows set table of contents and numbering with electronic upload via portal  30 day review of file for completeness  Clock stops when question posed with 30 day period for response  510K costs $19870 of SME $4967 (prior registration as small business required)

The Organisation for Professionals in Regulatory Affairs

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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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