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Medical Devices / Inspections and Audits

Health Canada Tweaks its MDSAP to Reduce Audit Times

Nov. 9, 2017

Health Canada has made significant changes to its Medical Device Single Audit Program with the goal of reducing audit times.

The MDSAP consortium announced Oct. 31 it has tweaked the program, in response to comments received from Canadian medical device license holders, by: reducing the total number of tasks, introducing reduction in audit time for manufacturers, reducing the duration of surveillance and re-certification audits, and clarifying the expectations for annual surveillance audits.

As the compliance deadline of Jan. 1, 2019 approaches for Canadian manufacturers, the consortium said it is also exploring other ways in which it could improve the program’s efficiency and reduce audit times, with plans to announce these sometime in the near future.

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