UI Pushes for Harmonisation of Medical Device Regulations in ASEAN

Universitas Indonesia (UI) is pushing for the creation of an adaptive, evidence-based, and internationally harmonised regulatory system for medical devices to respond to the rapid pace of medical technology innovation, such as artificial intelligence (AI), in the ASEAN region. “Medical technology is developing at an unprecedented rate. These innovations offer extraordinary opportunities to improve patient care, but they also require adaptive oversight systems to ensure safety,” said UI Vice Rector for Academic and Student Affairs, Prof Mahmud Subandriyo, at the opening of the ASEAN–Japan Medical Devices Regulatory Symposium 2026 in Jakarta on Tuesday. As one of the implementing agencies for the symposium, supported by the Japan-ASEAN Integration Fund (JAIF) and the Japan International Cooperation Agency (JICA), UI believes that universities have a responsibility that extends far beyond the boundaries of education and research. Mahmud emphasised that campuses hold a strategic role in bridging scientific discovery, technological innovation, and public policy formulation. This is demonstrated through the active involvement of the UI Faculty of Pharmacy in strengthening cross-border health oversight and regulatory capacity in Southeast Asia. He stressed the importance of post-market surveillance to monitor the real-world performance of medical devices, arguing that a robust oversight system is not a barrier to industry but rather a foundation for sustainable growth. “The benefits of local production and innovation can only be sustained if every medical device on the market consistently meets safety standards. Market authorisation is not the end of regulatory responsibility, but rather the beginning of safety,” he stated. Meanwhile, Hiraiwa Masaru, Executive Director of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), added that global digital technology advances, such as AI increasingly integrated into medical devices, demand regulatory collaboration between countries. To address the challenges of borderless innovation, the PMDA continues to engage with ASEAN nations through membership in the International Medical Device Regulators Forum (IMDRF) to ensure quality and safety standards for medical technology are maintained at both regional and global levels.