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TFDA continues its collaboration with the European Union in the context of TCP III

【Update Date:2024-01-29unit:品質監督管理組

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) on 1st Jan 2022. In addition, three European Union (EU) Notified Bodies (NBs) were included to the TCP III on 2nd Sep 2022 and 7th Jan 2023, respectively. The list of designated 9 NBs for TCP III was attached with this press-release and could be found on TFDA website.

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. The implementation of TCP III assists medical device manufacturers in both Taiwan and the EU in complying with the regulations for medical devices on both sides. Adhering to the principles of equality and reciprocity, it provide favourable to medical device manufacturers from both Taiwan and the EU. By taking advantage of international cooperation and sharing inspection resources, it aims to strengthen regulatory collaboration between Taiwan and the EU.