The Medical Device Single Audit Program (MDSAP) enables medical device manufacturers to undergo a single audit accepted by MDSAP member countries.
As an Auditing Organization (AO), our MDSAP services help you comply with the quality management system (QMS) regulatory requirements for the medical device regulatory authorities of Australia, Brazil, Canada, the US 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 sustainability, quality and integrity. 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)
- US: 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.
Contact us to discover the benefits of MDSAP.
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
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