Medical device shortages: Report a discontinuation
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Who should report
Manufacturers and designated importers :
You must report to Health Canada if your medical device is:
- a Class I, II, III or IV device
- being discontinued
- on the List of medical devices - Notification of shortages and
- discontinuing the device will lead to a shortage
How to report
field form (with checkboxes)
Option 1. I am discontinuing a medical device that will lead to a shortage
- For a Class I medical device:
- fill out the Report a medical device discontinuation form
- For a Class II, III or IV medical device:
- fill out the Report a medical device discontinuation form and
- email the Medical Devices Directorate at devicelicensing-homologationinstruments@hc-sc.gc.ca
Option 2. I am discontinuing a medical device that will not lead to a shortage
- For a Class I medical device:
- update your medical device establishment licence (MDEL) when it's time to renew
- For a Class II, III or IV medical device:
- email the Medical Devices Directorate at devicelicensing-homologationinstruments@hc-sc.gc.ca
We also encourage you to voluntarily report discontinuations that will lead to a shortage for devices not found on the List of medical devices - Notification of shortages.
The requirements to report when you are discontinuing to sell a medical device are outlined in sections 62.23(2) and 43(3) of the Medical Devices Regulations. The regulations specify when you must report a discontinuation as well.
If you are not sure whether to notify us about a discontinuation of a particular device, email us at md.shortages.penurie.de.im@hc-sc.gc.ca.
What to include in your 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
You must complete these fields when you submit a medical device discontinuation report or update report to Health Canada.
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