Draft guidance for reporting medical device shortages: Who must report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
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Mandatory shortage reporting
Manufacturers of Class I to IV devices and importers of Class I devices must report shortages to Health Canada for devices that belong to a category included on the List of medical devices - Notification of shortages. This is specified in section 62.23 of the Regulations.
To avoid duplicate reporting, a manufacturer may permit any importer of a medical device to prepare and submit a shortage report on its behalf (refer to section 62.24). This is permitted only when the information that would have been reported by the manufacturer and importer is identical.
The manufacturer must complete the following form to permit an importer to report on their behalf:
Manufacturers can email the form to Health Canada at MD.shortages.Penurie.de.IM@hc-sc.gc.ca.
Voluntary shortage reporting
Manufacturers, importers, provinces/territories and other stakeholders are encouraged to voluntarily report shortages of medical devices, even if they are not on the List of medical devices - Notification of shortages, if:
- the shortage may cause a patient or user safety issue in Canada
- a compatible substitute medical device, component, accessory or part is not available in Canada or cannot be easily replaced
- for example, due to capital equipment costs, regulatory requirements to update procedures, non-compatibility of surgical instruments or with other devices, extensive training required to use the replacement, or
- the shortage is national in scope
Voluntary shortage reporting provides Health Canada with information on the medical device supply chain. This information can help us identify categories of medical devices that may be added to the List of medical devices - Notification of shortages.
If you are not sure whether to report a shortage of a device, you may contact us at MD.shortages.Penurie.de.IM@hc-sc.gc.ca.
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