Medical Device Single Audit Program (MDSAP) – Global market access

Medical Devices

Streamline global market entry with DNV’s MDSAP certification. A single regulatory audit covering multiple jurisdictions helps medical device manufacturers achieve more efficient compliance across key markets.

Services from DNV

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 participating 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. DNV is a fully recognized Auditing Organization under the MDSAP program and also certifies quality management systems for medical devices.

What is MDSAP Certification?

The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo one comprehensive audit against ISO 13485:2016 that also incorporates regulatory requirements for multiple jurisdictions:

SR 236/2002 (Australia)
RDC ANVISA 665/2022 (Brazil)
SOR/98-282 (Canada)
MHLW MO 169 (Japan)
21 CFR Part 820 (USA – Quality Management System Regulation (QMSR), incorporating ISO 13485:2016; effective Feb 2, 2026)

Additional regulators engage with MDSAP as Official Observers (e.g. EU, Singapore HSA, UK MHRA, WHO IVD PQ) or Affiliate Members (including Argentina, Israel, Kenya, Republic of Korea, Mexico, Taiwan, South Africa and Malaysia) and may use MDSAP audit outputs within their oversight activities.

This single QMS audit can reduce the need for multiple national inspections, cutting duplication and supporting more efficient access to key global markets.

Manufactures seeking to operate across multiple regulated markets.

Companies seeking to streamline compliance audits.

Organizations facing multi-jurisdiction QMS inspections.

Manufacturers requiring support for facility registration and device market access activities, including regulatory expectations for device listing and facility licensing.

Healthcare professional completing regulatory compliance documentation, representing MDSAP audit preparation and quality management processes

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.

Hospital monitoring equipment and ICU environment, highlighting medical device safety, regulatory oversight, and MDSAP global market access

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 covering multiple regulatory jurisdictions, helping support access to global markets.
A structured, process-based audit approach that strengthens regulatory readiness through risk-based evaluation.