Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices: Notice

Date published: 2023-02-22

On this page


Health Canada made 3 interim orders to authorize the importation and sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19. The interim orders were put in place to accelerate access to these medical devices in Canada during the pandemic. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3) took effect on February 21, 2022, and expired on February 21, 2023.

On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) (Regulations) came into force. These Regulations are located in Part 1.1 of the Medical Devices Regulations (MDR).

We introduced these Regulations to continue accelerated access to COVID-19 medical devices for which there is an urgent public health need without relying on temporary regulatory measures.

About the amendments

These Regulations:

Part 1.1 of the MDR will provide the same pathway as under IO No. 3 to issue an authorization for:

To support the Regulations, we have published the following guidance document:

This guidance document explains how to apply for an authorization to import and sell COVID-19 medical devices.

What this means for authorization holders

Part 1.1 of the MDR allows manufacturers, importers and distributors to continue to import and sell COVID-19 medical devices that were authorized under IO No. 3. For example:

Upon the coming into force of the Regulations, the following continue to apply:

What this means for authorized devices not on UPHN list

Authorization holders of a COVID-19 medical device not on the UPHN list will need to comply with additional requirements to continue to import and sell the device. The requirements will depend on the class of the device. When a COVID-19 medical device is no longer on the UPHN list, we will inform the authorization holder of additional requirements that apply.

Once a COVID-19 medical device is no longer on the UPHN list, the following additional requirement will apply:

We also amended the Fees in Respect of Drugs and Medical Devices Order. For more information on the applicable fees, please consult the following guidance document:

What this means for purchasers and users

Purchasers and users are not affected, as devices authorized under Interim Order No. 3 may continue be sold under the Regulations.

Anyone, other than the device manufacturer, who imports or distributes an interim order-authorized device for use in Canada must obtain a medical device establishment licence (MDEL). Health care facilities and retailers are exempt from holding an MDEL.

For details on who needs to hold an MDEL and how to submit an application, please consult the following guidance document:

Find more details on authorized medical devices for uses related to COVID-19.

Summary reporting

Health Canada amended sections 61.4 to 61.6 of the MDR (summary reporting provisions) to:

While the language in the Regulations has been revised to be clearer, the intent is the same.

To understand and comply with the regulatory requirements for summary reports, refer to the following guidance document:

Contact us

For more information, please contact our Medical Devices Directorate at

For questions about the MDEL process, please email us at

For questions about your particular authorization or application or about new applications, please email us at

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: