What is MDSAP?

The Medical Device Single Audit Program (MDSAP) allows Auditing Organizations  (AO) recognized and accredited by the Regulatory Authorities of the five participant countries (USA, Canada, Brazil, Japan and Australia) to conduct a single audit of medical device manufacturers to ascertain that they meet the quality management requirements (Good Manufacturing Practice – GMP) of the aforementioned countries.

The three-year pilot project of MDSAP started on January 1, 2014, and it was replaced by the full program on January 1, 2017.

MDSAP replaced the Canadian Medical Devices Conformity Assessment System (CMDCAS).  The two-year transition period ended on December 31, 2018, and, after January 1, 2019, only MDSAP certificates are accepted.

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