About MDSAP

The MDSAP allows a recognized Auditing Organization (AO) to conduct a single regulatory audit of a medical device manufacturer that satisfies the requirements of the following regulatory authorities (RAs):

• Australia’s Therapeutic Goods Administration (TGA)
• Brazilian Health Regulatory Agency (ANVISA)
• Health Canada (HC)
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)
• U.S. Food and Drug Administration (USFDA)

These five RAs form the MDSAP Regulatory Authority Council (RAC), the decision-making body of the MDSAP. The RAC provides direction, oversight, and resources to support the MDSAP development, implementation, maintenance, and expansion.

For more details, please visit the website here.

About MDSAP Forum

The RAC is pleased to announce the 2026 MDSAP Forum will be held at Kyoto International Conference Center (ICC Kyoto).

During the week of the Forum, the MDSAP Regulatory Authorities will have the opportunity to discuss the current operation of the MDSAP and advance work on enhancement activities with current and potential Official Observers, Affiliate Members and Auditing Organizations participating in the event, as well as invited industry bodies and manufacturers. The Forum Agenda will also include Regulatory Authority updates and technical discussions and workshops.