ARCHIVED List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (2023-02-22 to 2023-11-09)

Notice to Reader

This is an archived list. Please refer to the most current version of this list.

This List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (UPHN list) is incorporated by reference in the Medical Devices Regulations (MDR) in the definition of UPHN medical device and in section 68.01.

Pursuant to subsection 68.1(1) of the MDR, the Minister of Health (the Minister) may add medical devices to Part 1 of the UPHN list. The Minister has reasonable grounds to believe that there is an urgent public health need (UPHN) related to COVID-19 for these devices.

Pursuant to subsection 68.1(2) of the MDR, the Minister may add categories of medical devices to Part 2 of the UPHN list. The Minister has reasonable grounds to believe that there is a UPHN related to COVID-19 for the devices that belong to those categories.

As the pandemic evolves, Health Canada will continue to assess the UPHN for the devices and categories of devices on the List.

For more information, please refer to:

• Medical devices for use in relation to COVID-19

Part 1. Medical devices that have a UPHN related to COVID-19

Name of device	Identifier of device

Part 2. Categories of medical devices that have a UPHN related to COVID-19

Category of medical devices
testing devices that offer a multiplex feature for detecting COVID-19 and other respiratory pathogens (for example, influenza A, B and respiratory syncytial virus)
molecular or antigen tests that offer saliva sample types
testing devices that offer other unique sample types
testing devices that offer a unique feature that meets a clinical or accessibility need
testing devices that offer environmentally sustainable features
medical devices that do not belong to any other category of medical devices set out in Part 2 of the List for which an application for an authorization was submitted to the Minister under Interim Order No. 3 Footnote 1 before the day on which Part 1.1 of the MDR came into force, and in respect of that application: no decision had been made under the Interim Order before that day, no decision has been made under Part 1.1 of the Regulations, and the applicant has not withdrawn the application.
Footnote 1 Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 Return to footnote 1 referrer

Contact us

David Boudreau
Director General
Medical devices directorate
Health Products and Food Branch
Email: mddpolicy-politiquesdim.sc@hc-sc.gc.ca

Related links

• COVID-19 medical devices