June 4, 2020
As part of its efforts to equip Canada to fight Covid-19, Health Canada’s Interim Order dated March 30, 2020 created an obligation on manufacturers and importers of medical devices to notify Health Canada when there are likely to be shortages of specific medical devices.
Health Canada specifies these devices in its published List of Medical Devices – Notification of Shortages.
The fact that a device is included in the List of Medical Devices – Notification of Shortages means that it may be imported and sold, on 5 days notice to Health Canada, upon meeting certain but not all of the ordinary regulatory requirements specified in the Medical Devices Regulations.
As of May 19, 2020, Health Canada has updated its List of Medical Devices – Notification of Shortages to include the following:
Class I Medical Devices
Masks (surgical, procedure or medical masks) - Level 1, 2, 3 (ATSM)
N95 respirators for medical use
Gowns - Level 2, 3 and 4
Class II Medical Devices
Pulse Oximeters (single measurement)
Class III Medical Devices
Ventilators (including bi-level positive airway pressure machines)
Pulse Oximeters (continuous monitoring)
Author: Richard Naiberg