Publication of third Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users

Date published: February 21, 2022

Health Canada introduced 2 interim orders on the importation and sale of medical devices for use in relation to COVID-19 to accelerate access to certain medical devices in Canada during the pandemic. The first interim order was created on March 18, 2020, which was replaced by the second interim order (Interim Order No. 2) on March 18, 2020.

As Interim Order No. 2 was set to expire in March 2022, Health Canada has put in place a third interim order (Interim Order No. 3). Interim Order No. 3 maintains the same flexibilities as Interim Order No. 2 so that authorized COVID-19 medical devices can continue to be sold and imported in Canada.

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Overview

The first and second interim orders provided a streamlined regulatory process to authorize the importation or sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19, while ensuring that safety, effectiveness and quality standards are met. Interim Order No. 2 was set to expire on March 1, 2022.

To maintain the flexibilities and regulatory oversight provided under the second interim order, Health Canada has introduced Interim Order No. 3. While Interim Order No. 2 can still be read online, Interim Order No. 3 repeals and replaces it.

Interim Order No. 3 allows COVID-19 medical devices authorized under Interim Order No. 2 to continue to be imported and sold in Canada. COVID-19 medical devices with an interim order authorization are found on the following lists:

Health Canada previously communicated to stakeholders on our website that Interim Order No. 2 would transition to regulations before it expires. However, the new highly transmissible and virulent SARs-CoV-2 variants have necessitated maintaining the expedited authorization pathway introduced through the interim orders. The interim order pathway continues to offer accelerated access to priority COVID-19 medical devices, including test kits and respirators.

What this means for manufacturers and applicants

The intention of Interim Order No. 3 is to maintain the same flexibilities offered under Interim Order No. 2. All application requirements remain the same as those in the second interim order, unless communicated otherwise. As such, all Interim Order No. 2 active authorizations and expanded use indications will continue under Interim Order No. 3. No action will be required from the manufacturer.

Manufacturers of authorized devices under Interim Order No. 2 may continue to import and sell their devices in Canada under Interim Order No. 3.

Any terms and conditions placed on an interim order authorization issued under Interim Order No. 2 remain in effect under Interim Order No. 3. Manufacturers are to continue to operate under those existing terms and conditions.

All applications that were made under Interim Order No. 2 and are still in process will be evaluated under Interim Order No. 3. These include amendment applications. No action is required from the manufacturer.

What this means for medical device purchasers and users

There is no impact as devices authorized under Interim Order No. 2 may continue be sold under Interim Order No. 3.

Anyone, other than the device manufacturer, who imports or distributes an interim order-authorized device for human 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:

Next steps

We expect that Interim Order No. 3 will remain in place for up to 1 year. Future updates for this project will be available in the following document:

Contact us

For more information, please contact our Medical Devices Directorate at mddpolicy-politiquesdim.sc@hc-sc.gc.ca.

For questions about the MDEL process, please email us at mdel.questions.leim@hc-sc.gc.ca.

For questions about your particular IO authorization or application or about new applications, please email us at devicelicensing-homologationinstruments@hc-sc.gc.ca.

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