Medical device shortages: Report a shortage
It is now mandatory for manufacturers and importers to report shortages of medical devices related to COVID-19 to Health Canada.
The requirements are outlined in the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. The Interim Order specifies which medical device shortages must be reported.
How to report
The following information must be included in shortage reports:
- name and contact information for the manufacturer or the importer
- medical device licence number in the case of Class II, III or IV devices
- identifier of the device
- includes the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or device group family
- name of the device and of any component, accessory, part or consumable material of the affected device, including, if applicable, the model name
- description of the medical device
- date on which the shortage began or is anticipated to begin
- date on which the manufacturer anticipates meeting the demand for the medical device, if known
At a minimum, these fields must be completed when submitting a medical device shortage report, update, or final report to Health Canada.
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