Medical Device Single Audit Program (MDSAP)
One Audit. Broader Global Access.
The Medical Device Single Audit Program (MDSAP) offers a more efficient route to international regulatory compliance. Through a single audit, manufacturers can address the quality management system requirements of multiple participating regulatory authorities—reducing duplication, improving consistency, and supporting faster access to key global markets.
DEKRA is a recognized independent Auditing Organization, delivering MDSAP audit services with the expertise and global perspective medical device manufacturers need to move forward with confidence.
The value of MDSAP at a glance
• Japan: MDSAP audit reports can help streamline market access by supporting exemption from certain on-site inspections and reducing selected submission requirements for the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).
• United States: The U.S. Food and Drug Administration (FDA) accepts MDSAP audit reports in place of routine FDA inspections, helping manufacturers simplify oversight activities.
• Canada: For manufacturers entering the Canadian market, MDSAP certification is a key component of Health Canada’s licensing framework.
• Australia: The Therapeutic Goods Administration (TGA) considers MDSAP audit reports as part of the evidence used in Australia’s conformity assessment process.
• Brazil: Brazil’s National Health Surveillance Agency (ANVISA) uses MDSAP audit outcomes as valuable input for both pre-market and post-market evaluations.
How DEKRA supports you
MDSAP currently covers Australia, Brazil, Canada, Japan, and the United States. As a recognized Auditing Organization, DEKRA provides more than audit execution alone. We combine global regulatory insight, practical audit experience, and timely program updates to help manufacturers navigate MDSAP requirements with clarity and confidence. From audit readiness to a broader understanding of participating regulatory authority expectations, our specialists are here to support your next step toward international market access.