Health Canada updates list of medical devices for mandatory reporting of shortages

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Mandatory reporting of medical device shortages

On March 1, 2021, the Minister of Health approved Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (IO No. 2). This interim order repeals and replaces the previous interim order of March 30, 2020.

Under IO No. 2, manufacturers and importers must report shortages of specified medical devices (including their components, accessories or parts) of critical medical devices to Health Canada. This new interim order outlines the mandatory reporting requirements.

To report shortages, manufacturers and importers are to complete the electronic shortages reporting form.

For more information, refer to the pages on medical device shortages and reporting. You may also consult the COVID-19 guidance document for reporting medical device shortages (GUI-0137).

Reporting shortages of specified medical devices

The list of medical devices - notification of shortages is incorporated by reference (IBR) in IO No. 2. Health Canada maintains and updates this list regularly.

The list was updated on May 20, 2021, to include additional medical devices that require mandatory reporting by manufacturers and importers. The list now includes (new items in bold):

Manufacturers and importers are responsible for periodically reviewing this list to ensure that they are submitting mandatory shortage reports for the required medical devices. Health Canada will not notify companies every time we update this list.

Reporting shortages of other medical devices

Manufacturers and importers are also encouraged to report shortages of medical devices that are not on the list of specified medical devices. We encourage voluntary reporting from manufacturers for a medical device shortage when:

You may also submit a voluntary shortage report using our electronic shortages reporting form.

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