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
On February 22, 2023, Health Canada introduced 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). These Regulations accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. They also make it possible to continue to import and sell COVID-19 medical devices authorized under the interim order. For more information, please refer to the notice on Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices and guidance on Medical devices for use in relation to COVID-19.
Health Canada created the Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19 (IO No. 1) to accelerate access to certain medical devices in Canada during the COVID-19 outbreak. IO 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.
On this page
- Overview
- What this means for manufacturers and applicants
- What this means for device purchasers and users
- References made to Interim Order No. 1 in Health Canada documents
- Next steps
- Contact us
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 mddpolicy-politiquesdim.sc@hc-sc.gc.ca.
For any questions about the MDEL process, please email us at hc.mdel.questions.leim.sc@canada.ca.
Related links
- Interim order respecting the importation and sale of medical devices for use in relation to COVID-19
- Applications for medical devices under the interim order for use in relation to COVID-19: Guidance document
- Authorized medical devices for uses related to COVID-19: List of authorized testing devices
- Medical Devices Regulations
- Guidance on medical device establishment licensing
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