"The University of Indonesia and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are promoting regulatory harmonization for the benefit of both ASEAN and Japan," said Deputy Minister of Health Dante Saksono Harbuwono.
Speaking at the ASEAN-Japan Medical Devices Regulatory Training 2025 in Jakarta on Wednesday, he highlighted the rapid advancement of technologies such as software as a medical device (SaMD), artificial intelligence (AI), the Internet of Things (IoT), and self-diagnostic tools.
As these technologies evolve, ASEAN countries face an urgent need to harmonize regulations to address shared challenges, he noted.
To that end, the Indonesian Health Ministry, Japan’s PMDA, and the Faculty of Pharmacy at the University of Indonesia have launched a two-year project titled "ASEAN-Japan Medical Devices Regulatory Training 2025."
The first-year activities were held in Jakarta from May 14 to 16, and included a one-day symposium attended by hundreds of participants, followed by a two-day seminar involving 40 medical device regulators from ASEAN countries.
Participants discussed a range of issues from global and regional perspectives, including updates from the International Medical Device Regulators Forum (IMDRF), the WHO prequalification process for in vitro diagnostics (IVDs), and Japan’s use of SaMD, such as computer-aided detection (CADe) and diagnostics (CADx).
The event provided a platform for exchanging knowledge and experience among regulators, academics, industry representatives, and medical device associations at both regional and international levels.
Harbuwono said that the training represents a strategic step toward building a common understanding of technical standards, adverse event reporting, and post-market surveillance.
"This training allows Indonesian regulators to meet their counterparts from Japan and other Asian countries, enabling us to develop strategies for entering the global market," he added.
The project is fully supported by the Japan-ASEAN Integration Fund (JAIF), with additional assistance from the Japan International Cooperation Agency (JICA).
It aims to strengthen the capacity of ASEAN medical device regulators and harmonize regulations that are adaptive to technological advancements in the medical sector.
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Translator: Anita Permata Dewi, Yashinta Difa
Editor: Anton Santoso
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