Taiwan FDA hosts “2026 APEC Medical Devices & Good Registration Management Regulatory Science Center of Excellence Workshop”

To promote regulatory convergence across the Asia-Pacific region and enhance the quality and efficiency of drug registration management and medical device regulatory science, the Taiwan FDA organized the 2026 APEC Medical Devices (MD) & Good Registration Management (GRM) Regulatory Science Center of Excellence (CoE) Workshop from August 26 to 28. This year’s workshop was endorsed by the APEC Regulatory Harmonization Steering Committee (RHSC) as an official training program. The MD session invited industry, academia, and regulatory experts from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the Japan Medical Imaging and Radiological Systems Industries Association (JIRA), Taiwan’s Center for Drug Evaluation (CDE), and TFDA. A total of 76 participants were trained with a focus on the application of International Medical Device Regulators Forum (IMDRF) guidances. Through group discussions and case studies, participants explored the full life-cycle management of medical devices and exchanged practical experiences. Arrangements were also made for international regulators to visit a local medical device manufacturing facility to observe how the Taiwanese industry implem...