The latest news on the reopening of AO applications for recognition and the introduction of new criteria for screening and prioritizing submissions.
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 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
Recent updates to MDSAP procedures, including Complaints and/or Customer Feedback