Medical device shortages: Report a discontinuation

On this page

• Who should report
• How to report
• What to include in your report

Report a discontinuation

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.