Updates to list of medical devices for mandatory shortage reporting: Notice

This notice is to inform licence holders that the List of Medical Devices – Notification of Shortages was updated on February 10, 2022, to include additional medical devices that require mandatory reporting by manufacturers and importers. Health Canada maintains and regularly updates this list, which is incorporated by reference (IBR) in Interim Order no. 2 (IO no. 2).

Under IO no. 2, manufacturers and importers must report shortages of specified medical devices (including their components, accessories or parts) to Health Canada.

To report shortages, manufacturers and importers must complete the electronic shortages reporting form. For more information on medical device shortage reporting, please refer to the:

The new additions include:

Class I medical devices:

Class II medical devices:

Manufacturers and importers are responsible for periodically reviewing the List of Medical Devices – Notification of Shortages to ensure they’re submitting mandatory shortage reports for the required medical devices.

Manufacturers and importers may also report shortages for medical devices not found on the List of Medical Devices – Notification of Shortages. Health Canada accepts voluntary reporting for a medical device shortage when:

You can submit voluntary shortage reports by using our electronic shortages reporting form.

Contact us

For inquiries, please contact: MD.shortages.penurie.de.IM@hc-sc.gc.ca.

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