The third generation of Technical Cooperation Programme on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III) has been announced by Taiwan Food and Drug Administration (TFDA), and will take effect on 1st Jan 2022. The list of designated European Notified Bodies (NBs) for TCP III was attached with this press-release and could be found on TFDA website.
As Taiwan’s Medical Device Act and European Medical Device Regulation (MDR) have come into effect in this May, the TCP II was no more valid on 25th May 2021. In consideration of the TCP II partners could smoothly transfer to TCP III under the COVID-19 pandemic, a transition period of TCP III was taken into force, and will be expired at the end of 2021.
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