In order to explain sections 63-65 of the MDR (Medical Devices Regulations), Health Canada issued the “Medical Devices recall guide” (ref. GUI-0054) on November 3, replacing the previous “Guidance on medical device recalls” issued in 2011.

The new guidance is more focused on responsibilities and recall activity procedures, instead of technical topics.

Moreover, this guidance explains and advices on some key points, as the collection of distribution records, reporting activities to Health Canada and implementation of quality system procedures.

Finally, flowcharts and checklists are included in order to help Manufacturers, Importers and Distributors in recall activities.


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