Medical Device Single Audit Program (MDSAP) Services

MDSAP enables medical device manufacturers to undergo a single audit that is accepted by MDSAP member countries. As an Auditing Organization (AO), our MDSAP services help you to comply with the quality management system (QMS) regulatory requirements for the medical device regulatory authorities of Australia, Brazil, Canada, the United States and Japan.

Why choose MDSAP services from SGS?

We help you to:

• Understand the requirements with our MDSAP training courses
• Get an MDSAP audit
• Gain a comprehensive review of your QMS
• Leverage MDSAP's audit report to simplify QMS surveys

Participating in MDSAP enables you to:

• Gain access to multiple markets with a single audit
• Minimize business disruption, while optimizing time and resources
• Ensure complete coverage of the requirements of all five participating regulatory authorities
• Schedule your routine audits directly with your SGS team

Why SGS?

We are the world’s leading provider of testing, inspection and certification services. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.

As an AO, we can conduct a single audit that will be accepted by the regulatory authorities of the following jurisdictions and their regulatory requirements:

• Australia: Therapeutic Goods Administration of Australia (TGA) – Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Parts 1 or 4
• Brazil: Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) – RDC ANVISA 665/2022, RDC ANVISA n. 23/2012 and RDC ANVISA n. 67/2009
• Canada: Health Canada (HC) – Medical Devices Regulations – SOR/98-282 with amendment 2020-262SOR/2020-262
• Japan: Japan's Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) – MHLW Ministerial Ordinance No.169 (2004)
• USA: United States Food and Drug Administration (FDA) – 21 CFR 820 and 21 CFR 821

The audit also covers other specific requirements of medical device regulatory authorities participating in the MDSAP program, including registration, licensing, technical documentation review and adverse event reporting.

The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program and the European Union (EU) are Official Observers of MDSAP.