Japan Hosts Asia-Pacific’s First 2026 MDSAP Forum

MDSAP is an international framework in which participating regulatory authorities evaluate and accredit private MDSAP auditing organizations and use reports and certificates from medical device manufacturing and quality management system (QMS) audits in their national regulatory operations. Using these outputs helps eliminate duplication in QMS audits of manufacturing sites conducted by individual countries.

Together with the United States, Canada, Australia, and Brazil, Japan participates in the operation and development of MDSAP as a member of the Regulatory Authority Council (RAC), which oversees the program.

Inviting non-member countries and SEARN deepened understanding of MDSAP in the Asia-Pacific region and created an opportunity for dialogue toward expanding participation and use.

The exchange of views among regulatory authorities, industry representatives, and auditing organizations is positioned to strengthen cooperation with the countries concerned and promote international cooperation in medical device regulation.

The open session shared information on the operation of the program and future initiatives by RAC member authorities, regional regulatory trends reported by official observers, affiliate members’ experiences using MDSAP outputs, expectations and challenges of non-member countries, industry action plans, and improvement proposals from auditing organizations.

Closed sessions were held on June 15, 18, and 19, 2026, providing non-member countries, affiliate members, and auditing organizations with training on MDSAP and its use by regulatory authorities, as well as workshops using individual cases.

Among the non-member countries, Indonesia, Thailand, Vietnam, and Egypt participated in person, while India participated via the web. The SEARN secretariat and its member countries Sri Lanka and Bhutan also participated in person.