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Taiwan FDA hosts 2019 APEC Medical Devices Regulatory Science Center of Excellence (CoE) Pilot Workshop

【Update Date:2019-10-22unit:醫療器材及化粧品組

              As part of Taiwan’s continuous effort in the promotion of using international standards for medical devices and the advancement of regulatory harmonization in the Asia-Pacific region, Taiwan Food and Drug Administration (TFDA) is hosting the ‟2019 APEC Medical Devices Regulatory Science Center of Excellence Pilot Workshop” from October 22 through 24 in Taipei. A total of 12 overseas and local experts invited from the regulatory authorities and medical device industry including German Federal Ministry of Health, Japan Pharmaceuticals and Medical Devices Agency (PMDA), Shimadzu Corporation, Royal Philips, TUV Rheinland of Japan, will deliver training to more than 44 trainees from 8 APEC member economies including Indonesia, Malaysia, Papua New Guinea, Philippines, Russia, Singapore, Thailand and Taiwan, and share their experiences on the concepts of using international standards for conformity assessment of medical devices. The participants will promote effective management of medical device lifecycle, implement harmonized approaches, and seek to facilitate regulatory convergence for medical devices within APEC economies.

APEC is one of the most important multilateral economic cooperation forums for regulatory authorities in the Asia-Pacific region. TFDA has long been participating in the APEC LSIF-RHSC to promote the regulatory convergence, and was endorsed in March 2019 to host an APEC Training Center of Excellence (CoE) for Regulatory Science pilot for Medical Devices. With this endorsement, TFDA is working towards establishing a closer relationship with APEC LSIF-RHSC and becoming a formal APEC Training CoE for Regulatory Science to conduct training of medical devices on a continuous basis, in order to achieve Taiwan’s goal of promoting medical device regulatory convergence, capacity development and international cooperation.