Background
In recent years, the TGA has enacted several reforms to advance regulatory harmonization or reliance. Manufacturers are able to 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 Australian Register of Therapeutic Goods (ARTG).
Further amendments related to this initiative have been made this year, and the TGA also targets additional amendments to align with the EU regulatory system under the MDR 2017/745 and IVDR 2017/746.
Review of Recent Regulatory Amendments in Australia: International Harmonization and Reliance
Review of Recent Regulatory Amendments in Australia: International Harmonization and Reliance
Australia’s regulator, the Therapeutic Goods Administration (TGA), has implemented several significant regulatory reforms for medical devices and IVDs so far this year, with more on the horizon.
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