Medical Device Single Audit Program (MDSAP) – Global Market Access
Streamline global market entry with DNV’s MDSAP certification; one audit covering multiple regulatory jurisdictions to help medical device manufacturers achieve faster, more efficient compliance.
Medical Device Single Audit Program (MDSAP) – Global Market Access
Achieve global market entry with one streamlined audit – DNV helps manufacturers meet compliance requirements across five major regulatory markets. With decades of experience in medical device regulatory certification, DNV brings deep expertise in understanding and applying regulatory requirements to your specific operations.
We have global experts ready to support your MDSAP audits and we are fully accredited to certify quality management systems for medical devices, ensuring trusted and compliant outcomes for our customers.
What is MDSAP Certification?
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo one comprehensive audit, against ISO 13485:2016, that covers regulatory requirements for multiple jurisdictions:
- Australia (TGA).
- Brazil (ANVISA).
- Canada (Health Canada).
- Japan (MHLW/PMDA).
- United States (FDA).
- Plus affiliate regulatory authorities.
This single QMS audit replaces separate national inspections, cutting duplication and accelerating access to key global markets.
DNV’s MDSAP certification services
Our support spans the entire certification lifecycle:
- Review of compliance with requirements and audit readiness, before on-site audit.
- Full-process compliance assessment combining quality and regulatory checks in a single audit.
- Regulatory reporting and liaison with audit outcomes accepted by TGA, ANVISA, Health Canada, MHLW/PMDA, FDA.
- Annual QMS surveillance audits to maintain currency and global certification.
- Expert training to stay audit-ready with up-to-date knowledge of the regulatory requirements.
Why partner with DNV?
Our comprehensive offering is built on global experience and technical proficiency:
- Worldwide presence with localized support from trusted regulatory authorities.
- Combined audits for MDSAP, ISO 13485 as well as the MDR and/or IVDR to streamline compliance.
- One audit, multiple market accesses simplifying access to global markets.
Resources to support your MDSAP journey
Access practical guides and expert insights to streamline your MDSAP certification and achieve global market access with confidence.
Medical Device Certification
Ensuring safety, compliance, and trust across the medical device lifecycle
Mecial Device Single Audit Program - webpage
Learn more about MDSAP and how a single audit supports multi-market compliance.
MDSAP Audit Procedures and Forms
Download tools, forms, and documentation to prepare for MDSAP audits and maintain compliance.
Frequently Asked Questions about MDSAP certification
Find answers to key questions about MDSAP certification, audit processes, and regulatory requirements.
Declaration of Interest Medical Service
Submit your Declaration of Interest to initiate or continue your MDSAP certification process.
