Medical device shortages: Report a shortage
Manufacturers of Class I to IV devices and importers of Class I devices must report shortages to Health Canada for medical devices that belong to a category included on the List of Medical Devices - Notification of Shortages. The requirements are outlined in sections 62.21 to 62.26 of the Medical Devices Regulations. These Regulations specify which medical device shortages must be reported. The Regulations replace Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2), which expires on March 1, 2022.
Manufacturers, importers and other stakeholders may also report shortages of medical devices not found on the List of Medical Devices - Notification of Shortages. You may send in your voluntary report using this form.
To support medical device shortage and discontinuation reporting, Health Canada has posted guidance for reporting medical device shortages and discontinuations (GUI-0137).
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
- reason for the shortage
- summary of the information the manufacturer or importer relied on to determine that a shortage of the device exists or is likely to occur
These fields must be completed when submitting a medical device shortage report, update or final report to Health Canada.
Report a problem or mistake on this page
- Date modified: