Manufacturers applying to register a medical device or IVD with the Australian Register of Therapeutic Goods (ARTG) now have more options to leverage to fulfill the Manufacturer Evidence requirement to support an application. As a result, manufacturers may leverage their EU CE Marking Certificate issued under the IVDD to fulfill the Manufacturer Evidence requirement until the dates listed below.
The Australian medical device regulator, the Therapeutic Goods Administration (TGA), has enacted several reforms to further advance regulatory harmonization or reliance. Manufacturers can leverage existing conformity assessment evidence issued by a comparable overseas regulator or assessment body as the Manufacturer Evidence to support an application to add a medical device or IVD to the ARTG.
Further amendments were made last year, and the TGA targets additional amendments to align with the EU regulatory system under the MDR 2017/745 and IVDR 2017/746. The most recent development in line with these efforts is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination (No. 3) 2024 (hereinafter, the Amendment Determination), which amends the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 (hereinafter, the Principal Determination).
Australian TGA Expands EU Transitional IVDR Arrangements for New Inclusion IVD Applications
Manufacturers applying to register a medical device or IVD with the Australian Register of Therapeutic Goods (ARTG) now have more options to leverage to fulfill the Manufacturer Evidence requirement to support an application.
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