MDSAP Updates and Possible Requirement in Brazil

By Luis Levy, Ken Pilgrim and Evangeline Loh

Background MDSAP

As we’ve reported, the IMDRF Medical Device Single Audit Program (MDSAP) continues to make progress with an increasing number of Affiliate Members as well as dependence on the MDSAP certificate. At the June 2025 meeting, it was reported that 7,357 facilities participated in MDSAP (7,060 in 2024), an increase of 4.2%. 

MDSAP only remains compulsory for Health Canada Class 2, 3, and 4 devices (medical device licenses). However, if a manufacturer is marketing a device in any of the Regulatory Authority Council (RAC) member countries (Australia, Brazil, Canada, Japan and the U.S.): the country must also be included within the scope of the MDSAP audit/certificate. There are benefits to MDSAP certification with the Affiliate Member countries as well. 

Background ANVISA Priority 2026-2027

One of ANVISA’s identified priorities is to assess the possibility of requiring MDSAP for foreign manufacturers. Currently, 65% of Brazil BGMP certificates published are based on MDSAP certificates. ANVISA has formally included this topic in its regulatory agenda, under Section 5.6 – Mandatory participation in MDSAP for the purpose of certifying foreign manufacturers of medical devices (revision of RDC nº 687/2022). For mandatory MDSAP participation to be implemented, ANVISA must first publish a Public Consultation (Consulta Pública) to gather input from stakeholders and the regulated industry. Following the consultation, the proposal would be consolidated and submitted for deliberation by ANVISA’s Board of Directors (Diretoria Colegiada-DICOL). Only after formal approval would the requirement be incorporated into the revised version of RDC nº 687/2022 and become legally binding.

The question remains, will ANVISA join Health Canada and require MDSAP certificates for higher-risk medical devices?   

MDSAP updates

The MDSAP website is now fully operational with news and document updates periodically posted. Note the 2026 MDSAP Forum will be June 15- June 16 in Kyoto, Japan. 

In the last few months, five documents have been updated; three forms, one report, and one policy document: NC Grading and Exchange Form, Key Activities Matrix, Stage 1 Assessment Report, Medical Device Regulatory Audit Report, and Audit Approach. The Audit Approach in particular is seen by industry as the “guidebook” for conducting medical device QMS audits, even for internal audits.

Concluding remarks

The IMDRF and MDSAP continues to advance the concept of a global QMS. This is of course further bolstered by the U.S. FDA Quality Management System Regulation (QMSR) which now incorporates by reference ISO 13485.