Expert Exchange Meeting

International standards and standardization activities, such as those developed by ISO and IEC, play a critical role not only in enhancing industrial and corporate competitiveness, including access to global markets, but also in the regulatory framework for medical devices. In Japan, such standards are incorporated into regulatory requirements under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), contributing to ensuring the quality, efficacy, and safety of medical devices.

In order to further promote international standardization activities--namely, regulatory harmonization through the utilization of international standards--it is important to ensure the participation of diverse stakeholders and to facilitate the sharing and advancement of specialized expertise. From this perspective, the Pharmaceuticals and Medical Devices Agency (PMDA), Office of Medical Device Standards, organizes the Expert Exchange Meeting to enhance expertise in international standardization in the medical field and to strengthen professional networks. This initiative provides a platform where stakeholders from industry, academia, and regulatory authorities come together to engage in cross-sectoral discussions on challenges and initiatives related to international standardization, including activities of Technical Committees (TCs).

Through this initiative, participants enhance their knowledge and expertise, share common challenges in international standardization, explore potential solutions, and strengthen collaboration among stakeholders. PMDA remains committed to contributing to the further advancement of international standardization activities in Japan through such public-interest initiatives.

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