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

Date published: March 1, 2021

Health Canada created the Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19 (Interim Order No. 1) to accelerate access to certain medical devices in Canada during the COVID-19 outbreak. Interim Order No. 1 was set to expire in March 2021. For this reason, Health Canada has issued a second interim order. This Interim Order No. 2 extends the flexibilities of the first so that devices can continue to be sold and imported in Canada.

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Overview

Interim Order No. 1 provides a streamlined regulatory process to authorize the importation or sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19, while maintaining safety standards. Interim Order No. 1 was set to expire on March 18, 2021.

Health Canada introduced Interim Order No. 2 before Interim Order No. 1 expired. We did this to maintain the flexibilities and regulatory oversight until at least the fall of 2021. Interim Order No. 2 repeals Interim Order No. 1, which can still be read online.

Interim Order No. 2 allows COVID-19 devices authorized under Interim Order No. 1 to continue to be imported and sold. COVID-19 devices with interim order authorization are found on the following lists:

Health Canada is also developing transition regulations so that COVID-19 devices could continue to be imported or sold after Interim Order No. 2 ends, in compliance with the Medical Device Regulations. The proposed transition regulations would take effect when Interim Order No. 2 ends and would remain in place for 2 years. For more information on the policy changes under Interim Order No. 2 and the transition regulations, please see this notice.

What this means for manufacturers and applicants

The intention of Interim Order No. 2 is to provide a seamless transition from Interim Order No. 1. As such, all active authorizations and expanded use indications authorized under Interim Order No. 1 will be considered as authorizations under Interim Order No. 2. No action will be required from the manufacturer.

Manufacturers may continue to import and sell their devices in Canada under Interim Order No. 2, as they did under Interim Order No. 1.

Any terms and conditions placed on an interim order authorization issued under Interim Order No. 1 remain in effect under Interim Order No. 2. Manufacturers are to continue to operate under those existing terms and conditions.

All applications that were made under Interim Order No. 1 and are still in process will be considered as applications under Interim Order No. 2. These include amendment applications. No action is required from the manufacturer.

What this means for device purchasers and users

Devices authorized under Interim Order No. 1 may continue to be purchased under Interim Order No. 2.

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) by September 1st, 2021. Health care facilities and retailers are exempt from holding an MDEL. Health Canada's Guidance on medical device establishment licences (GUI-0016) gives a detailed explanation of who needs to hold an MDEL and how to submit an application.

References made to Interim Order No. 1 in Health Canada documents

Stakeholders should read references to the numbered provisions of Interim Order No. 1 that appear in Health Canada documents as references to the equivalent provisions in Interim Order No. 2. Note that the numbering of some provisions has changed, as follows:

Interim Order No. 1 Interim Order No. 2
section 1 section 1
section 2 subsection 1(2)
section 3 section 2
section 4 section 4
section 5 section 5
section 6 section 6
section 7 section 7
section 8 section 8
section 9 section 9
section 10 section 10
section 11 section 12
section 12 section 13
section 13 section 14
section 14 section 15
section 15 section 16

Next steps

It's anticipated that Interim Order No. 2 will remain in place until at least the fall of 2021. At this time, Health Canada plans to introduce transition regulations for all devices authorized under Interim Order No. 1 or Interim Order No. 2.

We will soon be consulting with interested industry stakeholders, health system partners and other government departments on the proposed guidance for the transition regulations.

Contact us

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

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

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