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  5. IMDRF/MDSAP WG and GTHF Documents
  1. Medical Device Single Audit Program (MDSAP)

IMDRF/MDSAP WG and GTHF Documents

“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

Regulatory Authority Related Requirements/Guidance