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 ‟2021 APEC Medical Devices Regulatory Science Center of Excellence Workshop” during August 28 to September 11 by online courses.

Several overseas and local experts invited from the regulatory authorities, including Japan Pharmaceuticals and Medical Devices Agency (PMDA), will deliver training to 66 trainees from 7 APEC member economies and share their experiences on the concepts of using essential principles for conformity assessment of medical devices and on the clinical evaluation.

Participants will promote effective management of medical device lifecycle, implement harmonized approaches, and seek to facilitate regulatory convergence for medical devices within APEC economies.

Among the trainees of Chile, Colombia, Germany, Hong Kong, India, Indonesia, Malaysia, Philippines, Saudi Arabia, Singapore, Thailand, United States, Zimbabwe, and Chinese Taipei, there are 41 participants from regulatory authorities overseas, 9 participants from foreign medical device industry, 4 participants from TFDA, and 12 participants from domestic medical device industry.

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. The agency is a formal Center of Excellence (CoE) for the training on regulatory science of medical devices. 

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.