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

This notice is to inform licence holders that the List of Medical Devices – Notification of Shortages was updated on July 05, 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 to Health Canada shortages of specified medical devices (including their components, accessories or parts) related to COVID-19.

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 II medical devices:

• ventilators:
• bi-level positive airway pressure or BiPAP machines
• continuous positive airway or CPAP machines

Class III medical devices:

• ventilators:
• bi-level positive airway pressure or BiPAP machines

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 related to COVID-19. 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 also submit voluntary shortage reports by using our electronic shortages reporting form.

Contact us

For inquiries or to submit an authorization form, please contact: MD.shortages-penurie.de.IM@canada.ca.