The Medical Device Single Audit Program allows a recognized Auditing Organization, such as us, to conduct a single regulatory audit of a medical device manufacturer's quality management system that addresses the applicable requirements of participating regulatory authorities. MDSAP is based on ISO 13485 requirements together with additional country-specific regulatory requirements, supporting a more consistent and efficient approach to regulatory oversight for manufacturers operating in multiple markets.
Medical device manufacturers operating across multiple markets face the burden of separate regulatory audits for each country where they sell their products, creating complexity, cost and disruption to operations.
As a recognized MDSAP Auditing Organization, we conduct a single regulatory audit that satisfies the relevant requirements of participating regulatory authorities, including the Therapeutic Goods Administration of Australia, Brazil's ANVISA, Health Canada, Japan's Ministry of Health, Labour and Welfare and PMDA, and the U.S. FDA – helping you streamline access to international markets.
- Achieve market access with the single auditAccess five markets through one audit, supporting consistent quality and improved patient health outcomes.
- Minimize disruptionReduce audit fatigue and operational disruption, saving time and resources.
- Combine other assessment to maximize efficiencyIncorporate ISO 13485, ISO 9001 and EU MDR/IVDR audits alongside your MDSAP audit with one visit, keeping due dates in sync.
- Access dedicated supportWork with an account management team dedicated to your medical device project.
- Benefit from global expertiseDraw on our worldwide network and local market knowledge, wherever you operate.
Discover our services
- ISO 13485 quality management system certificationWe certify your quality management system against the international standard for medical device manufacturers.
- EU Notified Body servicesWe support CE marking of your medical device through conformity assessment under the EU MDR or IVDR, as applicable.
- UK Approved Body servicesWe support UKCA marking and access to the UK market through conformity assessment under applicable medical device regulation.
- MDSAP auditingWe help you streamline your quality system audits across multiple markets through the Medical Device Single Audit Program.
Why SGS?
As the world’s leading testing, inspection and certification company, we bring extensive regulatory and technical expertise, and now free transfers to support medical device manufacturers throughout the product lifecycle. Through our accredited certification bodies, Auditing Organization, EU Notified Body and UK Approved Body services, we support quality management system certification, conformity assessment and access to key global markets.
Ready to take the next step with MDSAP?
Contact us to learn how we can support your regulatory journey through conformity assessment, ISO 13485 certification and auditing services for CE marking, UKCA marking, MDSAP and other global market access needs.
FAQs
The MDSAP Regulatory Authority Council members include the regulatory authorities of Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW and PMDA) and the United States (FDA). MDSAP also includes official observers and affiliate members, though their country-specific requirements are not audited during MDSAP audits. We recommend determining which regulatory requirements apply based on the markets where your devices are, or are intended to be, sold.
Whether MDSAP is required depends on your target market and the applicable regulatory requirements. It is mandatory in Canada as the sole acceptable QMS certification for device license applications of medical devices Class II and higher, though it is not required for Canadian Class I devices. In other participating jurisdictions, regulators may use or recognize MDSAP audit results, but alternative means of obtaining market authorization exist. We can help you evaluate the requirements applicable to your devices and target markets.
ISO 13485 establishes requirements for a medical device quality management system, which MDSAP uses as a basis, directly adding country-specific regulatory requirements to enable recognized Auditing Organizations to conduct regulatory audits covering the applicable requirements of participating authorities. MDSAP certification is also considered an unaccredited ISO 13485 certificate. We are both an accredited ISO 13485 certification body and a recognized MDSAP Auditing Organization, enabling us to discuss your certification and regulatory audit requirements within a broader market-access strategy.
MDSAP can help you address applicable regulatory requirements from multiple participating markets through a single audit program, support access to key international medical device markets, reduce duplication associated with multiple regulatory audits, strengthen quality management and regulatory compliance, identify gaps in your quality management system, improve regulatory readiness and demonstrate your commitment to medical device quality and compliance. For manufacturers operating internationally, MDSAP can form an important part of a global regulatory and market-access strategy.
Not completely. The U.S. FDA may accept MDSAP audit reports as a substitute for routine FDA inspections in applicable circumstances, but participation in MDSAP does not prevent the FDA from conducting inspections when it determines one is necessary. If you sell medical devices in the United States, you remain responsible for meeting all applicable FDA regulatory requirements.
Medical device manufacturers operate in an increasingly complex global regulatory environment. Working with us gives you access to extensive expertise in medical device quality management, auditing, certification and regulatory requirements. We support MDSAP alongside complementary medical device services, helping you develop a coordinated approach to quality, compliance and global market access.
Start by contacting us with information about your organization, manufacturing sites, medical devices, current certifications and target markets. Our medical device specialists can review your requirements, explain the MDSAP certification process and help determine the appropriate next steps.