ASEAN-Japan Medical Devices Regulatory Seminar 2026
The PMDA-ATC Medical Devices Regulatory Seminar 2026 for AMDC in Jakarta, Indonesia was held on July 1 and 2, 2026, in Jakarta, Indonesia, with support from the Japan-ASEAN Integration Fund (JAIF). The seminar brought together regulators from medical device regulatory authorities of ASEAN Member States (AMS) to enhance regulatory knowledge and promote regional cooperation in the field of medical devices.
On the first day of the seminar, lectures were delivered on post-market safety measures for medical devices in Japan, medical device regulatory reliance programs and QMS inspections for medical devices. Participants subsequently engaged in a roundtable discussion, where they exchanged information on the latest regulatory developments and challenges related to quality management systems (QMS) and post-market safety measures in their respective jurisdictions.
On the second day, lectures were delivered on post-market safety measures from an industry perspective, including the utilization of artificial intelligence (AI), as well as the Medical Device Single Audit Program (MDSAP). These sessions provided participants with opportunities to deepen their understanding of current regulatory approaches and international initiatives.
Participants also took part in a case study on post-market safety measures for medical devices. Working in groups, they discussed practical regulatory scenarios, shared experiences from their respective authorities, and presented their findings. Through these interactive discussions, participants enhanced their understanding of regulatory decision-making processes and strengthened professional networks among AMS regulators.
Throughout the seminar, participants actively exchanged views and experiences, contributing to fruitful discussions and a deeper understanding of medical device regulation. The seminar served as a valuable platform for strengthening regulatory cooperation and fostering mutual understanding among ASEAN regulatory authorities.
The seminar concluded with a closing ceremony, during which certificates of participation were awarded to the participants. PMDA reaffirmed its commitment to supporting regulatory capacity building and further collaboration with ASEAN partners in the medical device regulatory field.
(see the program for details[155KB])
Photos and participant comments
Comments from the participants:
“This training provides good information and knowledge on how important to regulate the medical devices and solved the problem.”
“The seminar was well organized and provided valuable insights into medical device regulation, post-market surveillance, MDSAP, and AI applications. The sessions were practical and informative.”
“The seminar was excellent and provided an avenue where participants can exchange regulatory experiences and learn from each other.”
“For future seminars, I suggest including more interactive case studies and allowing additional time for discussion and Q&A.”