“IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum. 

The IMDRF Medical Device Single Audit Program (MDSAP) Working Group develops a standard set of requirements for auditing organizations performing regulatory audits of medical device manufacturers’ quality management systems. The document will be applicable to competent authority auditing groups/inspectorates, as well as third party organizations that conduct such audits. This is an initial critical step in establishing a single audit program. 

If you have any questions, please send an email to mdsap@fda.hhs.gov 

 

Auditing Organization Related Requirements/Guidance

• IMDRF/MDSAP WG/N3 FINAL:2013 -- Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition
• IMDRF/MDSAP WG/N3 FINAL: 2016 (Edition 2) Requirement for Medical Device Audition Organizations for Regualtory Authority Recognition
• IMDRF/MDSAP WG/N4 FINAL:2013 --Competence and Training Requirements for Auditing Organizations
• IMDRF/MDSAP WG/N22 FINAL:2014 --MDSAP Overview of Auditing Organization Assessment and Recognition Decision Related Processes
• IMDRF/MDSAP WG/N24 FINAL:2015 --Medical Device Regulatory Audit Reports
• GHTF/SG3/N19:2012 -- Quality Management System€“ - Medical Devices€“ - Nonconformity Grading System for Regulatory Purposes and Information Exchange (PDF - 463KB)

Regulatory Authority Related Requirements/Guidance

• IMDRF/MDSAP WG/N5 FINAL:2013 --Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations
• IMDRF/MDSAP WG/N6 FINAL:2013 -- Regulatory Authority Assessor Competence and Training Requirements
• IMDRF/MDSAP WG/N8 FINAL:2015 -- Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations
• IMDRF/MDSAP WG/N11 FINAL:2014 -- MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization