Guide to reporting medical device shortages and discontinuations: Who must report
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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.
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:
- Authorization Form (FRM-0451) (PDF version)
Manufacturers can email the form to Health Canada at md.shortages.penurie.de.im@hc-sc.gc.ca.
Mandatory discontinuation reporting
Manufacturers or designated importers must report to Health Canada discontinuations that will lead to a shortage for devices on the List of Medical Devices - Notification of Shortages. This requirement is outlined in subsection 62.23(2) of the Regulations.
Voluntary shortage reporting
Manufacturers, importers, provinces/territories and other stakeholders may 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 helps us determine trends in the supply chain and identify where there are areas of risk or concern for 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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