Interim Order No. 3 The Sale of Medical Devices for COVID-19 use

Interim Order No. 3 The Sale of Medical Devices for COVID-19 use

Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim order) was made by the Minister of Health on February 21, 2022, in accordance with subsection 30.1(1) of the Food and Drugs Act. This third interim order maintains all the flexibilities of the second 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. The third interim order also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim orders.

Overview

The third interim order supports Canada’s ongoing focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians. It contributes to securing Canada’s COVID-19 medical devices supply chain by:

  • providing an expedited pathway for authorizing COVID-19 medical devices
  • helping to facilitate access to safe and effective COVID-19 medial devices for health care workers and other Canadians

From the outset, the COVID-19 pandemic has created challenges in global supply chains, including an unprecedented demand for certain medical devices. Medical device manufacturers and importers adapted quickly to meet demands for COVID-19 medical devices. New manufacturers also stepped in to create additional capacity.

Combined global efforts continue to identify ways to contain the pandemic and prevent further spread as well as find effective treatments and cures against this disease.

Requirements carried over from the previous interim order

As was the case under the second interim order, the third interim order provides for an expedited authorization pathway for COVID-19 medical devices. This contributes to ensuring Canadians have continued access to COVID-19 medical devices.

The third interim order continues to apply to all classes of medical devices and provides 3 authorization mechanisms:

  1. an expedited authorization pathway for importing and selling new COVID-19 medical devices
  2. expanded use indications for devices authorized under the Medical Devices Regulations or the third interim order without requiring the manufacturer to apply
  3. authorization of new COVID-19 medical devices that have been approved by a trusted foreign regulatory authority

The third interim order still allows the Minister to determine the level of evidence required to demonstrate the safety and effectiveness of devices authorized through the interim order, considering the urgent public health need. This new interim order continues to:

  • provide flexibility and regulatory oversight to enable ongoing importation, sale, and distribution of COVID-19 medical devices, including personal protective equipment
  • incorporate by reference the existing list of licensed or authorized medical devices for which an expanded use has been approved
  • ensure that all authorizations for medical devices issued under the previous interim order, including any terms and conditions on those authorizations, will remain in effect
  • require importers and distributors of all COVID-19 medical devices to hold a medical device establishment licence
  • maintain bilingual labelling requirements for manufacturers, importers, and distributors of all COVID-19 medical devices

Looking for assistance with your COVID-19 related medical device?

Further, any applications that are outstanding when the previous interim order expires will still be considered under the third interim order.

All authorized COVID-19 devices are subject to post-market requirements. These include incident reporting, reporting of a voluntary recall and record-keeping requirements related to distribution.

The Minister also maintains the ability, at any time, to:

  • impose or amend terms and conditions on authorizations
  • ask for more information or materials about a COVID-19 medical device submission, existing authorized device or expanded use

Health Canada will continue to monitor the safety and effectiveness of authorized COVID-19 medical devices. This includes taking immediate action, such as cancelling authorizations if required, to protect people’s health and safety.

Manufacturers of Covid-19 medical devices authorized under the third interim order will not be subject to evaluation, amendment, and right-to-sell fees.

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 COVID-19 medical device 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 medical 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 COVID-19 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.

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:

Resources:

Health Canada, February 21, 2022. Interim Order No. 3 Respecting the importation and sale of medical devices for use in relation to COVID-19. Retrieved from

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html

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