Medical devices are essential for the diagnosis, prevention, and treatment of diseases across all countries. The global medical device landscape is characterized by rapidly evolving technologies, including the Internet of Things (IoT), artificial intelligence, machine learning, remote monitoring devices, and at-home diagnostic tests that extend beyond traditional healthcare settings.

In particular, the technology for medical devices—such as Software as a Medical Device (SaMD)—is advancing at an unprecedented pace. To guarantee the safety and effectiveness of these emerging technologies and to fully leverage their significant potential benefits, it is essential to establish suitable regulatory measures that address the challenges they pose. Additionally, the timely integration of innovative and safe medical devices into healthcare practices is critical for improving patient outcomes.

In Asia, the ASEAN Medical Devices Committee (AMDC) is actively working to harmonize the technical requirements for pharmaceuticals and medical devices. To facilitate the swift and secure introduction of innovative medical devices in the ASEAN region, it is both urgent and essential to share information about these devices and to develop capacity-building programs for the regulatory authorities involved. These initiatives will not only enhance regulatory practices but also support the operations of medical device companies throughout ASEAN.

The ASEAN-Japan Medical Devices Regulatory Symposium and Seminar is a collaborative program organized by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, the Ministry of Health of the Republic of Indonesia (MoH), and the Faculty of Pharmacy at Universitas Indonesia (UI), with comprehensive support from the Japan-ASEAN Integration Fund (JAIF). This program will serve as a forum for information and knowledge sharing, addressing a wide range of current issues related to medical devices and in vitro diagnostics (IVDs) over a two-year period, including pre-registration activities in 2025 and post-marketing activities in 2026. The program consists of a two-day seminar tailored for four regulatory staff members from each ASEAN member state (AMS) and a one-day symposium aimed at disseminating essential regulatory information to industry and academia while fostering an exchange of perspectives between regulators and industry representatives. The goal of this project is to share information and experiences regarding medical device regulation, including reviews and safety measures among regulatory authorities, while also fostering capacity building to achieve regulatory harmonization. The content of the project addresses the training and capacity-building needs of AMS and aims to improve equitable access to safe, effective, and innovative medical devices for both communicable and non-communicable diseases in the ASEAN region.