Authorization of medical devices for an urgent public health need: List of medical devices for expanded use

Date issued: March 19, 2024

The List of Medical Devices for Expanded Use (expanded use list) is incorporated by reference in Part 1.1 of the Medical Devices Regulations (MDR).

Health Canada maintains and updates this list as required.

In the expanded use list:

• a medical condition is added to column 1 (section 68.351 of the MDR) when the Minister has reasonable grounds to believe:
  • the medical condition presents, or is the result of, a significant risk to public health in Canada
  • immediate action is required to deal with the risk
• a licenced medical device, or a Class II, III or IV medical device for which the manufacturer of the device holds an authorization, is added to column 2 and an expanded use is added to column 3 (section 68.36 of the MDR) when the Minister:
  • has reasonable grounds to believe there is an urgent public health need for the expanded use of the device that is related to the corresponding medical condition in column 1
  • has sufficient evidence to support the conclusion that the benefits associated with the expanded use outweigh the risks, given:
    • uncertainties about those benefits and risks
    • the urgent public health need for the device
  • determines the expanded use of the device will not unduly affect the health or safety of patients, users or other persons

In accordance with section 68.37 of the MDR, the Minister publishes supplementary information on:

• the expanded use of a licenced medical device (set out in column 3) or
• a Class II, III or IV medical device for which the manufacturer holds an authorization (set out in column 2)

The supplementary information includes:

• a statement of the expanded use
• a statement of the known and potential benefits and risks
• any supplement to the directions for use, unless a supplement is not required for the device to be used safely and effectively

For more information, please refer to:

• Medical devices for an urgent public health need

Access the archived version of this list

Contact us

Medical Devices Directorate
Health Products and Food Branch
Email: meddevices-instrumentsmed@hc-sc.gc.ca