On March 2, 2022, amendments to the legislation in Canada, Medical Devices Regulations (SOR/98-282, Part 1, Sections 62.21 to 62.26) came into force. These provisions discuss the notification of shortages to the regulator Health Canada. If an explicit device is delineated on the “List of Medical Devices- Notification of Shortages” and the manufacturer or importer notes the shortage “exists or is likely to occur,” a report needs to be completed and information about the shortage provided. The legislation also permits voluntary notification. Reporting of medical device shortages applies to manufacturers of Class I-IV medical devices and importers of Class I devices. In addition, manufacturers or designated importers are required to report if the manufacturer is discontinuing the sale of a specified medical device in Canada and whether the discontinuation may cause a shortage…
