On February 22, 2023, amendments to the Medical Devices Regulations (Regulations) came into force that create a permanent regulatory framework for COVID-19 medical devices: 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) (see also Health Canada’s notice and guidance).

To expedite access to COVID-19 medical devices, the Minister of Health made the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 in March 2020 (previously reported). This was repealed by the Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, which was in turn repealed by the Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (previously reported) (the Third Interim Order).

The amended Regulations are intended to maintain flexibilities and active authorizations granted under the Third Interim Order. Under the amended Regulations, Health Canada will publish and maintain the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (UPHN List). Authorization holders for medical devices on the UPHN List are granted regulatory flexibilities similar to those provided by the Third Interim Order (e.g., for manufacturers, this includes exemption from certain licence requirements under the Regulations). Authorizations granted under the Third Interim Order will remain in place under the amended Regulations, although additional requirements are triggered once a device is no longer on the UPHN List.

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