Medical device shortages: Report a discontinuation
It's mandatory for manufacturers and designated importers, who have been authorized to report on behalf of a manufacturer to report discontinuations to Health Canada that will lead to a shortage for devices on the List of Medical Devices - Notification of Shortages.
This requirement is outlined in Section 62.23(2) of the Medical Devices Regulations. The Regulations specify when a medical device discontinuation must be reported.
Note: To report a discontinuation under section 43(3), contact the Medical Devices Directorate at firstname.lastname@example.org.
Manufacturers, importers and other stakeholders may also voluntarily report discontinuations that will lead to a shortage for devices not found on the List of Medical Devices - Notification of Shortages. Use the following form to report:
How to report
Include the following information in your discontinuation reports:
- name and contact information of 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 discontinuation began or is anticipated to begin
- reason for discontinuation
These fields must be completed when submitting a medical device discontinuation report or update report to Health Canada.
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