Health Canada has updated the list of medical devices for mandatory reporting of shortages in relation to COVID-19

MDEL Bulletin December 3, 2020, from the Medical Devices Compliance Program

On March 30, 2020, the Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. This makes it mandatory for manufacturers and importers to report shortages of specified medical devices related to COVID-19, as well as their:

• parts
• accessories
• components
• consumable materials

Health Canada maintains the List of Medical Devices - Notification of Shortages. It is incorporated by reference in the interim order and may be amended from time to time. Manufacturers and importers must report shortages by completing the electronic shortages reporting form.

The List of Medical Devices - Notification of Shortages was updated on November 30, 2020, and now includes:

• Class I medical devices:
  • masks (surgical, procedure or medical masks) - Level 1, 2, 3 (ASTM)
  • N95 respirators for medical use
  • face shields
  • gowns (isolation or surgical gowns) - Level 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)
• Class III medical devices:
  • ventilators, including bi-level positive airway pressure machines
  • pulse oximeters (continuous monitoring)

Manufacturers and importers are responsible for regularly reviewing the List of Medical Devices - Notification of Shortages. They must ensure that they submit mandatory shortage reports for the required medical devices. Health Canada will not notify companies each time this list updates.

We encourage manufacturers and importers to voluntarily report shortages for medical devices not related to COVID-19 when:

• they’re national in scope
• they’re likely to create a patient or user safety issue in Canada
• a substitute device, component, accessory, consumable material or part is not readily available

Contact us

For inquiries or to submit an authorization form, contact hc.meddevmatmed.sc@canada.ca.

Related links

• Medical device shortages: overview
• COVID-19 guidance for reporting medical device shortages (GUI-0137)