The submission of application for participating in the Technical Cooperation Programme on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports between EU MDR/IVDR Notified Body Partners and R.O.C. Taiwan Food and Drug Administration (TFDA) Authorized Medical Device QMS Auditing Organizations (Known as TCP III) was open since last November. Up to date, TFDA has received 11 applications from EU MDR/IVDR notified bodies located in Germany, Netherlands, France, Belgium, and the U.K. The first stage of assessment process including its qualifications and quality management system review is in progress. All applicants need to go through the second stage assessment (including on-site auditing and witness audits) before successfully becoming a partner of TCPIII. The on-site auditing and witness audits are waiting for arrangements based on overseas travelling constraints from the COVID-19 pandemic. An EU MDR/IVDR Notified Body could successfully become a partner of TCP III once the assessment was completed and get the agreement signed. Any notified body designated under EU MDR/IVDR is interested to participate in the TCP III, a submission of application for participating in TCP III is welcome.

 

    The cooperation mechanism of under this Technical Cooperation Programme (TCP) was started in 2005, and many Taiwanese and EU medical device manufacturers have benefited from the TCP programme by reliance on the audit reports issued by TCP partners. Currently, the Technical Cooperation Programme on Exchange of Medical Device GMP and ISO 13485 Audit Reports between EU AIMD/MDD/IVDD Notified Body Partners and R.O.C. TFDA Authorized Medical Device GMP Auditing Organization, Version 2.0 (Known as TCP II) remains valid.

 

    In response to the forthcoming regulations on Taiwan Medical Devices Act and new application date for the new European Medical Device Regulation (MDR) announced by EC, the TCP II is expected to becoming to TCP III by 25 May 2021.