Transition Plan for the Medical Device Single Audit Program (MDSAP)

Health Canada is preparing the process of adopting the Medical Device Single Audit Program (MDSAP) in place of the current Canadian Medical Devices Conformity Assessment System (CMDCAS) which is slated to commence in 2017.

The program will allow device manufacturers to undergo a single audit to satisfy the quality requirements of five participating nations (the US, Australia, Brazil, Canada, and Japan), instead of facing many inspections from different regulators.

As Health Canada is keen to fully integrate MDSAP into its regulatory framework by January 2019, it has warned to suspend all medical device licenses that are not supported by a MDSAP certificate by the end of the transition period.

CMDCAS registrars have been given the opportunity to apply to be recognized as MDSAP auditing organizations so as to facilitate the transition process. To date, only five of the 13 CMDCAS registrars have been formally recognized to perform MDSAP audits.

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