Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need): SOR/2023-277 andOrder Amending the Fees in Respect of Drugs and Medical Devices Order (Medical Devices for an Urgent Public Health Need): SOR/2023-278

Other (TBT)

Medical Devices

Link to ePing

11.040 - Medical equipment; 11.040 - Medical equipment

E09. COVID-19 TBT; Human health; Human health

The proposed changes notified in G/TBT/N/CAN/692/Add.1 (dated 21 August 2023) were adopted and published on January 3, 2024, as the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (the Regulations). The amendments to Medical Devices Regulations (MDR) broaden the scope of Part 1.1, previously limited to COVID-19 medical devices, to apply to other future public health emergencies. The regulatory amendments also address a policy gap regarding applications in queue and clarify post-market obligations. These amendments will facilitate timely access to safe and effective medical devices when future public health emergencies arise in Canada. In line with the previously published COVID-19 medical device framework, the broadened framework under Part 1.1 is optional. The general licensing framework under Part 1 of the MDR remains available for manufacturers to consider. The amendments to the MDR also resulted in administrative changes to the Fees in Respect of Drugs and Medical Devices Order (Fees Order). The Fees Order was amended to reflect the broadened scope of the amended Part 1.1 of the MDR and the fees that apply for Class II to IV medical devices authorized under Part 1.1 once they no longer meet an urgent public health need.   The Regulations and the Fees Order amendments came into force on January 3, 2024, the day on which they were published in the Canada Gazette, Part II. 

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