Taiwan FDA hosts 2020 APEC Medical Devices Regulatory Science Center of Excellence (CoE) Workshop

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2020-08-29
  • Last Updated:2020-08-31

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 ‟2020 APEC Medical Devices Regulatory Science Center of Excellence Workshop” during August 29 to September 11 by online courses and videoconferences. Several overseas and local experts invited from the regulatory authorities and medical device industry, including Japan Pharmaceuticals and Medical Devices Agency (PMDA) and Shimadzu Corporation, will deliver training to more than 61 trainees from 10 APEC member economies, including Chile, Indonesia, Korea, Malaysia, Philippines, Singapore, Thailand, United States, Viet Nam, and Chinese Taipei, and share their experiences on the concepts of using essential principles 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 been participating in the APEC LSIF-RHSC to promote regulatory convergence for a long time, and has hosted the ‟2019 APEC Medical Devices Regulatory Science Center of Excellence Pilot Workshop” from October 22 through 24 in 2019 that received great acclaim. In this year, TFDA was endorsed in June to become a formal Center of Excellence (CoE) for the training on regulatory science of medical devices. With this endorsement, TFDA is working towards establishing a closer relationship with APEC LSIF-RHSC and conducting the APEC CoE training on a continuous basis, in order to achieve Taiwan’s goal of promoting medical device regulatory convergence, capacity development and international cooperation.