Health Canada is replacing the first interim order by Interim Order No. 2 respecting the importation and sale of medical devices for use in relation to COVID-19. This second interim order was published in Canada Gazette Part 1, vol 155 March 20, 2021. A notice to manufacturers, purchasers and users was also issued as the interim order was set to expire on March 18, 2021.
This new interim order maintains many of the flexibilities of the previous interim order, including the consideration of urgent public health needs. These flexibilities are needed to assess evidence that demonstrates the safety and effectiveness of medical devices. IO No. 2 also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim order.
Further, IO No. 2 introduces new requirements for medical devices authorized under this new interim order or the previous interim order:
- for importers and distributors of all medical devices to hold a medical device establishment licence (MDEL); and
- for all manufacturers, importers and distributors to comply with bilingual labelling requirements.
These new requirements align with those in the Medical Devices Regulations.
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.
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.
Medical devices for uses related to COVID-19
For more information, please contact our Medical Devices Directorate at firstname.lastname@example.org.
For any questions about the MDEL process, please email us at email@example.com.