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

MDEL Bulletin May 20, 2021 from the Medical Devices Compliance Program

On this page

• Mandatory reporting of medical device shortages
• Reporting shortages of specified medical devices
• Reporting shortages of other medical devices
• Contact us

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):

• Class I medical devices
  • masks (surgical, procedure or medical masks): Levels 1, 2 and 3 (ATSM)
  • N95 respirators for medical use
  • KN95 respirators for medical use
  • face shields
  • gowns (isolation or surgical gowns): Levels 2, 3 and 4
  • gowns (chemotherapy gowns)
• Class II medical devices
  • infrared thermometers
  • digital thermometers
  • oxygen concentrators
  • pulse oximeters (single measurement)
  • aspirators/suction pumps (portable and stationary)
  • laryngoscopes
  • endotracheal tubes
  • manual resuscitation bags (individually or part of a kit)
  • medical gloves: examination and surgical (nitrile, vinyl)
  • oxygen delivery devices
• Class III medical devices
  • ventilators (including bi-level positive airway pressure machines)
  • pulse oximeters (continuous monitoring
  • vital signs monitors
  • dialyzers
  • infusion pumps
  • anesthesia delivery devices
• Class IV medical devices
  • Extracorporeal Membrane Oxygenation (ECMO) Devices

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:

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

Contact us

If you have a question or wish to submit an authorization form, please contact us at hc.meddevmatmed.sc@canada.ca.