What is MDSAP (Medical Device Single Audit Program)?

In October 2011, the International Medical Device Regulators Forum (IMPDF) was created as a replacement of the Global Harmonization Task Force on Medical Devices (GHTF). IMPDF is a voluntary group of medical device regulators from around the world who wants to accelerate the international medical device regulatory harmonization and convergence. In 2012, the Medical Device Single Audit Program (MDSAP) Working Group was created to develop specific documents for advancing the concept of the Medical Device Single Audit Program

The main goal of the MDSAP is to provide a more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers.

The implementation of the MDSAP is intended to allow for a single audit that will satisfy the regulatory requirements of FDA, TGA, Health Canada and Anvisa .MDSAP includes the use of third party auditors in addition to the regulatory inspectorates.

MDASP pilot program started in January 2014 and medical device companies can participate into it on voluntary basis till 2016. After that it will be fully implemented

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