On February 22, 2023, 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) came into force. We introduced these amendments in Part 1.1 of the Medical Devices Regulations (MDR). The amendments were made to create a permanent regulatory framework to allow faster access to COVID-19 medical devices for which there is an urgent public health need.
On January 3, 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (regulations) came into force. These regulations broaden the scope of Part 1.1 to apply to future public health emergencies for which there is an urgent public health need, when necessary…
