COVID-19 guidance for reporting medical device shortages: Who must report
Health Canada has made the medical device shortage reporting framework permanent by transitioning interim order provisions to the regulations. The interim order expired on March 1, 2022, at which time the new shortage reporting framework took effect. For more information, visit the Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice
Under section 15(1) of Interim Order No. 2, manufacturers and importers must report medical device shortages to Health Canada for devices that are on the List of medical devices: Notification of shortages.
To avoid duplicate reporting, under section 16, a manufacturer may designate an importer of a medical device to prepare and submit a shortage report on its behalf. This is permitted only when the information that would have been reported by the manufacturer and importer is identical.
To delegate an importer, the manufacturer must submit a delegation of mandatory shortage reporting for medical devices authorization using the following form.
Email the form to Health Canada at MD.shortages-penurie.de.IM@canada.ca.
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