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MDSAP Archive

The Medical Device Single Audit Program (MDSAP) audit process is a consortium of IMDRF Regulators who established an operational program for a ‘Single Audit Program’ for medical devices, based on the IMDRF forum. MDSAP was designed and developed to provide an efficient yet thorough coverage of the Quality Management System requirements implemented by medical devices manufacturers. These requirements are based on ISO 13485 - Medical devices - Quality management systems, and the specific requirements from the medical device regulations of the Regulatory Authorities that are participating in the MDSAP.

MDSAP has been considered fully operational from 1 January 2019. For current information on implementation see the MDSAP website.

IMDRF technical documents
MDSAP code Document title Date posted Pages
IMDRF/MDSAP WG/N5 FINAL:2013 Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations - PDF (363kb) Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations - DOCX (313kb) 18 December 2013 32
IMDRF/MDSAP WG/N8 FINAL:2015 Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations - PDF (256kb) Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations - DOCX (154kb) 2 October 2015 53
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