Canadian Medtech Keeps An Eye On Transition To MDSAP; Regulator Won't Allow Grace Period

As Health Canada prepares to kick-start in 2017 its two-year plan to fully adopt the Medical Device Single Audit Program (MDSAP) in place of the current Canadian Medical Devices Conformity Assessment System (CMDCAS), the local medtech industry association MEDEC is upbeat about the change and says that while the transition plan may pose challenges, it believes it is too early to say what these might be1,2.

Health Canada is keen to fully integrate MDSAP into its regulatory framework by January 2019 and has stated that it will not offer any grace period to device manufacturers who fail to put