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Transition period to TCP III until the end of 2021

【Update Date:2021-07-06unit:品質監督管理組

    A transition period to fully take into force of 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). The list of designated European Notified Bodies (NBs) for the transition period was attached with this press-release and could be found from TFDA website. In consideration of the TCP II partners could smoothly transfer to TCP III under the COVID-19 pandemic, this TCP III transition period is scheduled to end on 31st December 2021.
    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. The application of TCP III has officially announced since 2019 and is remain open to any EU MDR and/or IVDR designated Notified Body who is interested in becoming a TCP III partner.
    For further information on TCP III and the application process, please contact Ms. Chang of TFDA at yellue202@fda.gov.tw, or Mr. Al-bert Lee of ITRI at alberttwli@itri.org.tw directly.