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The Third Version of Technical Cooperation Programme (TCP III) on exchange of medical device quality management system regulation and ISO 13485 audit reports

【Update Date:2019-11-21unit:品質監督管理組

The new European Medical Device Regulation (MDR) will be fully implemented on 26th May, 2020. The current TCP II will remain valid until 25th May, 2020. To facilitate the achievement of TCP, the application of TCP III has officially launched from now on. Any EU Notified Body certificated by MDR can request the TCP III agreement and propose the application to TFDA.
The detail content of TCP III and application process, please contact Mr. Yang Ching-Yao (chinyao@fda.gov.tw) of TFDA, or Mr. Albert Lee (alberttwli@itri.org.tw) of ITRI directly for further information.