The 2026 MDSAP Annual Forum was held from 15 to 19 June 2026 in Kyoto and was organized by PMDA/MHLW. It brought together representatives from Auditing Organizations (AOs), ‘Affiliate’ countries, ‘Observer’ countries of the program and MDSAP RAC members (Canada, United States, Brazil, Australia and Japan). During the forum, several member countries of SEARN* (South East Asia Regulatory Network) were also present to explain how MDSAP reports or certificates were being used as alternatives to ISO 13485 certificates. In addition, two days were devoted to an exchange of information with industry and its representatives.
The main topics discussed during the sessions with industry included a presentation on the MDSAP program, the status of the MDO Pilot Phase (Medical Device Organization) which is a program for entities that are not ‘legal manufacturers’, a presentation on ‘Affiliate’ status, the expectations regarding the MDSAP program from APC member countries (Egypt, India, Indonesia, Thailand, the Philippines and Vietnam), and a presentation on the activities of ‘Affiliate’ countries (Argentina, Israel, Kenya, Malaysia, Mexico, South Korea, South Africa and Taiwan). The second day dedicated to industry, focused more on regulatory update in member’s countries, as well as updates which occurred in observer countries (Europe, Singapore, UK and WHO). It was the opportunity for MHRA to inform the audience that the final stages to become a full member had begun, and a forecast of June 2027 was announced for the UK to become the sixth member country. The views of an industry representative and other industry representatives were also shared.
For its part, Europe reported on developments since the 2025 forum, the observations made, and its desire to observe more audits in the future in order to become more familiar with the program and identify synergies between regulatory programs. In this regard, the work of the working group responsible for mapping the quality system requirements of the MDR/IVDR regulations against the MDSAP Audit Approach document was also shared.
Finally, the general data on the MDSAP program presented at the forum show continued growth in the number of certified sites (approximately 7,700 in Q2 2026) spread across 71 countries worldwide.
*The South-East Asia Regulatory Network (SEARN) is a volunteer association of National Regulatory Authorities (NRAs) of South-East Asia responsible for the regulation of medical products. The current member countries are: Bangladesh, Bhutan, the Democratic People’s Republic of Korea, India, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste
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