ASEAN-Japan Medical Devices Regulatory Seminar 2025 Report
The event, titled “PMDA-ATC Medical Devices Regulatory Seminar 2025 for AMDC, in Jakarta, Indonesia,” was held on 15 to 16 May, 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 of regulators of medical device regulatory authorities of ASEAN Member States (AMS). This seminar was supported by the Japan-ASEAN Integration Fund (JAIF) as was the ASEAN–Japan Medical Devices Regulatory Symposium 2025, held on 14 May.
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).
The event closed with remarks from the Office Director of Asia Training Center and International Cooperation (OAIC), ENDO Ayumi, who reaffirmed continued support for collaboration with ASEAN, and also awarded participants with certificates of participation.
Programme details are available here.
