The first annual MDSAP RAC Report highlights key 2025 achievements and reinforces the RAC's commitment to advancing global regulatory collaboration.
Medical Device Single Audit Program
MDSAP allows a recognized Auditing Organization (AO) to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of participating Regulatory Authorities (RAs).
Our vision
Our vision for the MDSAP is to ensure the highest standards of safety for medical devices, whilst minimizing regulatory burden through use of an agreed single audit process. The MDSAP Regulatory Authorities are committed to protecting patient health and well-being by continuously improving our audit methodologies, fostering transparency, and upholding the integrity of medical device safety.
Latest news
This document sets out the roles and responsibilities of the MDSAP Industry Group and provides clarification on the group’s purpose, roles, responsibilities, operations, tenure and obligations in accordance with agreed terms with the MDSAP Regulatory Authority Council.
The 2026 MDSAP Forum, hosted by Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency, will be held in Kyoto from Monday 15 June 2026 to Friday 19 June 2026.