Medical device shortages: Report a shortage
It is mandatory for manufacturers and importers to report shortages of medical devices that are on the list of medical devices: notification of shortages to Health Canada.
The requirements are outlined in Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order No. 2). Interim Order No. 2 specifies which medical device shortages must be reported. It repeals and replaces Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 made by the Minister on March 30, 2020.
How to report
The following information must be included in shortage reports:
- name and contact information for the manufacturer and/or the importer
- Medical Device Licence (MDL) number in the case of Class II, III or IV devices
- authorization identification number for a device authorized for importation or sale under another interim order made under section 30.1 of the Food and Drugs Act
- device identifier
- 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 or part of the affected device, including the model name (if applicable), in both English and French
- description of the medical device, its packaging and an indication of whether it's a single-use 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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