List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19
Date issued: 2023-02-22
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:
|Name of device||Identifier of device|
|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:
Medical devices directorate
Health Products and Food Branch
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