Taiwan, EU continues cooperation on medical devicee quality regulation

This third rendition of the medical cooperation with the EU was introduced in January 2022.

Taiwan Food and Drug Administration (TFDA) and the European Union sustained their partnership in ensuring the compliance of the quality of medical devices in the regulations in both markets.

The third generation of the Technical Cooperation Programme on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III) was first unveiled by TFDA on 1 January 2022.

Additionally, three notified bodies from the EU were involved in the TCP III implementation on 2 September 2022 and 7 January 2023.

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"Adhering to the principles of equality and reciprocity, it provides favourable to medical device manufacturers from both Taiwan and the EU," TFDA said.

"By taking advantage of international cooperation and sharing inspection resources, it aims to strengthen regulatory collaboration between Taiwan and the EU," it added.

The application of TCP III has continued since 2019 and remained open to any EU MDR and/or IVDR-designated notified body interested in becoming a TCP III partner.