What is MDSAP?
Medical Device Single Audit Program (MDSAP) is a global auditing program designed to streamline regulatory compliance for medical device manufacturers. With just one audit, manufacturers can meet the regulatory requirements of multiple key markets: Australia, Brazil, Canada, Japan, and the United States. More jurisdictions are joining the program and are accepting MDSAP as basis for product registration such as but not limited South Korea, Singapore. You may refer to the MDSAP website.
Developed by the International Medical Device Regulators Forum (IMDRF), MDSAP allows manufacturers to demonstrate compliance with national regulations through a unified and recognized auditing process. Instead of undergoing separate audits for each market, companies benefit from a single, internationally accepted audit report.
TÜV USA Inc., a member of the TÜV NORD GROUP, is a recognized MDSAP Auditing Organization. We provide MDSAP audits that help manufacturers meet compliance standards across multiple jurisdictions. Our experts support you through the entire process — from initial planning to final certification.
