The Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3) maintains all of the flexibilities of its predecessor, including the consideration of urgent public health needs (UPHN). IO No. 3 also continues to allow the importation and sale of COVID-19 medical devices that were authorized under the previous interim orders.
IO No. 3 (made February 21, 2022) repealed and replaced a March 1, 2021 Interim Order (IO No. 2) of the same name. IO No. 2 had extended and updated the powers available under the first iteration of the Interim Order (IO No. 1), which was originally approved on March 24, 2020 to provide a streamlined process to authorize the importation and sale of medical devices used to diagnose, treat, mitigate, or prevent COVID-19.
IO No. 1 and IO No. 2 resulted in over 770 authorizations for COVID-19 medical devices being issued, including 107 testing devices (e.g., rapid test kits), and over 660 medical devices other than testing devices (e.g., personal protective equipment).
As we reported, as of July 16, 2021, Health Canada was no longer accepting applications for certain categories of medical devices under IO No. 2, namely thermometers and ventilators, due to a lack of an UPHN. Also reportedwas Health Canada’s intention to introduce transition regulations, which would have ended the expedited IO authorization pathway but extended current IO authorizations so that industry could meet therequirements for converting their IO approvals to medical device licenses under the Medical Devices Regulations (the Regulations). IO No. 2 was set to expire on March 1, 2022.
Interim Order No. 3
Given the emergence of COVID-19 variants, such as Omicron, the Government of Canada has determined that the best option for controlling the virus’s spread is to maintain the expedited IO authorization pathway for COVID-19 medical devices (e.g., test kits and N95 masks) so that accelerated access to such devices can continue for the health and safety of Canadians.
According to the Government, IO No. 3 maintains all of IO No. 2’s flexibilities and contains no substantive updates.
IO No. 3 continues to apply to all classes of medical devices and provides 3 authorization mechanisms:
- An expedited authorization pathway for importing and selling new COVID-19 medical devices;
- Expanded use indications for devices authorized under the Regulations, or IO No. 3, without requiring the manufacturer to apply; and
- Authorization of new COVID-19 medical devices that have been approved by a trusted foreign regulatory authority.
Under IO. No. 3, importers and distributors of medical devices must hold a medical device establishment licence in accordance with the Regulations, and manufacturers, importers, and distributors of IO-authorized devices mustcomply with bilingual labelling requirements.
IO No. 3 incorporates, by reference, the existing list of licensed or authorized devices for which an expanded use has been approved. All authorizations issued under IO No. 2 remain in effect, and any outstanding applications will be considered under IO No. 3.
IO No. 3, signed on February 21, 2022, was approved by the Governor in Council on March 3, 2022. It is expected to remain in effect for up to 1 year. An eventual transition to the Regulations is still contemplated, and future updates for that conversion will be published here: Forward Regulatory Plan 2021-2023: Regulatory Proposal to Transition the Interim Order Respecting the Importation and Sale of Medical Devices.
- Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed March 18, 2020; repealed and replaced by IO #2) (IO No. 1)
- Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed March 1, 2021; repealed and replaced by IO#3) (IO No. 2)
- Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (signed February 21, 2022) (IO No. 3)
- Explanatory note on Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19
- Publication of third Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers and users
- Medical Device Regulations, SOR/98-282