(Jakarta, 15th) Indonesian Deputy Minister of Health, Dante Saksono Harbuwono emphasized that the collaborative efforts between ASEAN and Japan in medical device regulatory systems are crucial for accelerating public access to innovative and safe medical technologies.
He stated at the '2025 ASEAN-Japan Medical Device Regulatory Training' held in Jakarta from May 14 to 16: 'The University of Indonesia and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are promoting regulatory coordination benefiting both ASEAN and Japan.'
Dante pointed out that with the rapid development of medical technology, such as Software as a Medical Device (SaMD), Artificial Intelligence (AI), the Internet of Things (IoT), and self-diagnostic tools, ASEAN countries face an urgent need to coordinate and unify regulatory standards.
To address these challenges, the Indonesian Ministry of Health, Japan's PMDA, and the University of Indonesia's School of Pharmacy have jointly launched a two-year '2025 ASEAN-Japan Medical Device Regulatory Training Program.' The first year's activities took place in Jakarta from May 14 to 16, including a symposium attracting hundreds of participants and a two-day professional training session for 40 medical device regulators from ASEAN countries.
The conference discussed topics covering the latest developments at both global and regional levels, including advancements from the International Medical Device Regulators Forum (IMDRF), the World Health Organization's pre-certification process for in vitro diagnostic equipment (IVD), and Japan's application experience in the SaMD field (e.g., computer-aided detection and diagnosis technologies CADe/CADx).
This training provided a platform for the exchange of knowledge and experiences among regulatory bodies, academia, industry representatives, as well as regional and international medical device associations.
Dante stated: 'This training is a strategic step toward establishing common technical standards, improving the adverse event reporting mechanisms, and post-market surveillance. It also offers Indonesian regulatory bodies the opportunity to communicate with peers from Japan and other Asian countries, formulating strategies for entering the international market.'
The project is fully funded by the 'Japan-ASEAN Integration Fund' (JAIF) and assisted by the Japan International Cooperation Agency (JICA), aiming to enhance the regulatory capacity of ASEAN countries for medical devices and promote the development of unified regulatory standards that adapt to the advancement of medical technology.
He stated at the '2025 ASEAN-Japan Medical Device Regulatory Training' held in Jakarta from May 14 to 16: 'The University of Indonesia and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are promoting regulatory coordination benefiting both ASEAN and Japan.'
Dante pointed out that with the rapid development of medical technology, such as Software as a Medical Device (SaMD), Artificial Intelligence (AI), the Internet of Things (IoT), and self-diagnostic tools, ASEAN countries face an urgent need to coordinate and unify regulatory standards.
To address these challenges, the Indonesian Ministry of Health, Japan's PMDA, and the University of Indonesia's School of Pharmacy have jointly launched a two-year '2025 ASEAN-Japan Medical Device Regulatory Training Program.' The first year's activities took place in Jakarta from May 14 to 16, including a symposium attracting hundreds of participants and a two-day professional training session for 40 medical device regulators from ASEAN countries.
The conference discussed topics covering the latest developments at both global and regional levels, including advancements from the International Medical Device Regulators Forum (IMDRF), the World Health Organization's pre-certification process for in vitro diagnostic equipment (IVD), and Japan's application experience in the SaMD field (e.g., computer-aided detection and diagnosis technologies CADe/CADx).
This training provided a platform for the exchange of knowledge and experiences among regulatory bodies, academia, industry representatives, as well as regional and international medical device associations.
Dante stated: 'This training is a strategic step toward establishing common technical standards, improving the adverse event reporting mechanisms, and post-market surveillance. It also offers Indonesian regulatory bodies the opportunity to communicate with peers from Japan and other Asian countries, formulating strategies for entering the international market.'
The project is fully funded by the 'Japan-ASEAN Integration Fund' (JAIF) and assisted by the Japan International Cooperation Agency (JICA), aiming to enhance the regulatory capacity of ASEAN countries for medical devices and promote the development of unified regulatory standards that adapt to the advancement of medical technology.