Medical Device Single Audit Program (MDSAP) Global QMS Progress

As global regulatory alignment gains momentum, the Medical Device Single Audit Program (MDSAP) continues to expand its influence across markets. In 2025, new Affiliate Members, a redesigned website, and regional updates from Korea, Mexico, and the U.S. Food and Drug Administration (FDA) highlight ongoing developments in harmonization and quality system oversight.

Background

The Medical Device Single Audit Program (MDSAP) has existed as an International Medical Device Regulator Forum (IMDRF) Working Group since 2012. It became a fully operational program in 2016 and has been compulsory only for manufacturers seeking to secure a Medical Device License (MDL) from Health Canada to date. However, suppose a manufacturer certified to MDSAP for one member of the Regulatory Authority Council (RAC) is also marketing products in one or more other member countries. In that case, the scope of the MDSAP audit (performed by the Auditing Organization) must also include the other member country(ies).   

New Affiliate Members

In 2025, the number of Affiliate Members has already increased by two. Most recently, the Malaysia Medical Device Authority (MDA) announced (Sept. 19) Affiliate Member status to MDSAP, joining the South African Health Products Regulatory Authority (SAHPRA) (April 4, 2025).

At the 2025 MDSAP Forum in Amsterdam, June 16-20, the EU discussed its vision for EU participation in MDSAP. During this time, MDSAP also released a new global website.

Updates from Affiliate Members

The South Korean Ministry of Food and Drug Safety (MFDS) Notice No. 2025-22 consolidates the K-GMP legislation. The Notice includes revisions released in December 2024 outlining the benefits of being an "excellent quality control” organization, and specifies that for Class 3 medical devices, an audit conducted by a Third Party Auditor (TPA) is sufficient to meet K-GMP requirements.

In Mexico, the national standard, NOM-241-SSA1-2025 on Good Manufacturing Practices was finalized (April 4), impacting entities based in Mexico.

Regulatory Authority Council (RAC)

The RAC has remained composed of five members: Four of the five founding Global Harmonization Task Force (GHTF) members, excluding Europe, which Brazil has replaced.

The most notable upcoming event is the U.S. FDA Quality Management System Regulation (QMSR), which will take effect on Feb. 2, 2026. The QMSR incorporates ISO 13485 by reference. Emergo has hosted a webinar on the topic. This webinar along with the U.S. Food and Drug Administration’s (FDA’s) frequently asked questions are both helpful resources.

Concluding remarks

From the RAC, MDSAP remains mandatory only for an MDL (Classes 2, 3 and 4) in Canada. A manufacturer with an MDSAP certificate can secure a B-GMP certificate with a four-year validity. Additionally, it is certainly exciting that the U.S. FDA has increased its harmonization and revised the Quality System Regulation to the QMSR, incorporating ISO 13485.

The IMDRF and MDSAP continue to advance the concept of a global QMS.