Notice: Updates to list of medical devices for mandatory reporting shortages related to COVID-19

This notice is to inform licence holders that the List of Medical Devices - Notification of Shortages was updated on October 22, 2021, 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:

• medical device shortages web page
• COVID-19 guidance for reporting medical device shortages (GUI-0137)

The new additions include:

Class III medical devices:

• chest drainage systems

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 are also encouraged to report shortages for medical devices not found on the List of Medical Devices - Notification of Shortages. Health Canada encourages voluntary reporting for a medical device shortage when:

• the shortage is likely to create a patient or user safety issue in Canada
• a substitute device, component, accessory or part is not readily available
• the shortage is national in scope

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.