Authorized medical devices for uses related to COVID-19: Overview

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How to identify authorized COVID-19 medical devices

In addition to existing medical device databases, there are new lists of authorized COVID-19-related medical devices. These lists are a result of new regulatory tools in place to expedite access to COVID-19 medical devices.

The following information explains what resources to check to determine if a medical device has been licensed or authorized in Canada.

Class I devices (such as masks, respirators, eye protection, gowns and swabs)

Class I medical devices can be imported or sold according to one of four possible mechanisms:

the manufacturer or importer holds a Medical Device Establishment Licence (MDEL)

the device is included in the list of authorized medical devices other than testing devices

the device is included in the list of medical devices for expanded use in relation to COVID-19

the device is included in the list of medical devices for exceptional importation and sale

Class II, III and IV devices (such as gloves, ventilators and testing devices)

Class II, III and IV medical devices can be imported or sold according to 1 of 5 possible mechanisms:

the device is included in the Medical Devices Active Licence Listing

the device is included in the list of authorized testing devices

the device is included in the list of authorized medical devices other than testing devices

the device is included in the list of medical devices for expanded use in relation to COVID-19

the device is included in the list of medical devices for exceptional importation and sale

Understanding the lists of authorized medical devices

Medical Device Establishment Licences

Class I devices can be imported or manufactured without an interim order authorization if the manufacturer or importer holds a Medical Device Establishment Licence (MDEL). Consult the list of active MDELs to see whether a company is authorized to import or manufacture Class I medical devices. Most personal protective equipment (PPE), with the exception of medical gloves, are Class I devices.

Medical Device Licences

Class II, III and IV devices are licensed in accordance with the Medical Devices Regulations. Consult the Medical Devices Active Licence Listing to see whether a Class II, III or IV device is licensed under the regulations. Certain gloves and ventilators that can be used for COVID-19 are licensed devices.

List of authorized testing devices

The list of authorized testing devices includes testing devices authorized under the interim order for importing and selling medical devices for COVID-19. Only testing devices authorized by Health Canada can be imported or sold in Canada. Unauthorized tests may not produce accurate results, leading to potential misdiagnosis. Health Canada confirms that authorized COVID-19 tests are well supported by evidence indicating they will provide accurate and reliable results.

Testing devices for COVID-19 contains more information on the types testing devices that Health Canada is authorizing. There is information on nucleic acid-based and serological testing devices, as well as guidance on the requirements for applications for serological testing devices.

List of authorized medical devices other than testing devices

This list includes medical devices authorized under the interim order for importing and selling medical devices related to COVID-19, other than testing devices. Included in this list are many devices, such as PPE, ventilator accessories and testing reagents.

List of medical devices for expanded use in relation to the COVID-19 pandemic

Some medical devices have been granted an expanded indication for use or intended use for COVID-19. These devices carry diagnostic, treatment, mitigation or prevention claims based on known evidence, in accordance with section 13 of the interim order for importing and selling medical devices for COVID-19. This list includes licensed or authorized devices for which an expanded use has been approved. Health Canada maintains the list and will update it as required. The list is incorporated by reference in the interim order for importing and selling medical devices for use in relation to COVID-19.

List of medical devices for exceptional importation and sale

Certain devices that may not fully meet regulatory requirements but are manufactured according to comparable standards can be included on the list of medical devices for exceptional importation and sale. They are eligible under the provisions of the interim order for drugs, medical devices and foods for a special dietary purpose in relation to COVID-19. Expired products or products that do not have English and French labelling are examples of medical devices that may be eligible for this pathway.

Health Canada maintains the list of medical devices for exceptional importation and sale and will update it as required. The list is incorporated by reference in the interim order. For more information, see exceptional importation and sale of medical devices in relation to COVID-19.

Expedited access to COVID-19 medical devices

The COVID-19 pandemic has created an unprecedented demand for medical devices. New mechanisms are in place to enable expedited access to medical devices, including two interim orders (IOs) signed by the Minister of Health. These IOs:

The use of an IO is one of the fastest ways to respond to large-scale public health emergencies.

For more information on how to get authorization, please consult medical devices for uses related to COVID-19. Health Canada reviews all COVID-19-related submissions and applications as quickly as possible without compromising patient safety.

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