ASEAN-Japan Medical Devices Regulatory Seminar 2025 Report
The event, subtitled “PMDA-ATC Medical Devices Regulatory Seminar 2025 for AMDC, in Jakarta, Indonesia” was held on May 15 and 16, co-hosted by the PMDA, the Ministry of Health of the Republic of Indonesia (MoH), and the University of Indonesia.
Forty participants invited to this seminar comprised regulators of medical device regulatory authorities of ASEAN Member States (AMS). This seminar was supported by Japan-ASEAN Integration Fund (JAIF) as was the ASEAN–Japan Medical Devices Regulatory Symposium 2025 , held on May 14.
The seminar began with a roundtable discussion on the current status and challenges in medical device regulations in AMS. The PMDA delivered a lecture on standards for medical devices and their application within Japanese regulations, MoH introduced “ASEAN Diagnostics Security and Self Reliance.”
A PMDA senior scientist, and a representative of the Japan Federation of Medical Devices Associations (JFMDA) delivered lectures on medical devices single audit program (MDSAP).
On the second day, participating regulators worked in groups, conducting case study on reviews of high-risk medical devices. Lectures on regulations and reviews of software as a medical device (SaMD) in Japan, and regulation of in-vitro diagnostics (IVD) followed.
Throughout the seminar, participants actively shared perspectives, enhancing their understanding of topics discussed.
The event closed with remarks from Ms. Ayumi ENDO, Office Director, Office of Asia Training Center and International Cooperation of the PMDA, who reaffirmed continued support for collaboration with ASEAN, and also awarded participants with certificates of participation. Attendees were also awarded ‘Open Badge,’ a digital certificate of participation.
(see the program for details[220KB])
Photos and participant comments
Comments from the participants:
“The speakers and organizing committee are very helpful.”
“All lectures and group discussion are good, participants almost acquired too much knowledge.”
“Good and informative sessions at the seminar”
“This session is very good for all AMS to exchange information and will benefit implementation and planning for future work.”
“The core of the clinical review process will be applied in national and ASEAN joint assessment.”