To promote the use of international standards for evaluating the safety and performance of medical devices, and thereby advance regulatory harmonization in the Asia-Pacific region, the Taiwan Food and Drug Administration (TFDA) is hosting the ‟2024 APEC Medical Devices Regulatory Science Center of Excellence Workshop” (APEC CoE Workshop) from August 28 to August 30 in both in-person and virtual formats. This workshop provides training to 47 representatives of the industry, government, and academia from 17 economies, including Botswana, Chile, El Salvador, Indonesia, Malaysia, Mexico, Oman, Papua New Guinea, Peru, the Philippines, Russia, Singapore, South Africa, Switzerland, Tanzania, Vietnam, and Chinese Taipei.

TFDA has been conducting the APEC CoE Workshop annually since 2019. This year the workshop is being held for the sixth time, with a training program endorsed by the APEC Regulatory Harmonization Steering Committee. Government officials and industry regulatory experts from Japan and Taiwan were invited to serve as instructors, sharing their experience with medical device guidance documents developed by the International Medical Device Regulators Forum. And by way of group discussion, the principles and practical experiences of medical device safety and performance were exchanged. In addition, TFDA also arranged for overseas regulators to visit the facilities of local device manufacturers. Through detailed explanations by manufacturers, regulators learned how the Taiwan industry implements international standards and perceived TFDA’s emphasis on promoting international harmonization of medical device regulations.