Health Canada has proposed amendments to the Medical Devices Regulations (Regulations) that would expand the regulatory framework for COVID-19 medical devices to apply to future public health emergencies (see Proposed changes to the Medical Devices Regulations to address future public health emergencies: Notice).

Under the proposed amendments, Part 1.1 of the Regulations would no longer be specific to COVID-19 medical devices. Instead, Part 1.1 would apply to medical devices that have an urgent public health need (UPHN) in relation to a medical condition for which there is a public health emergency. The proposed amendments would also:

The proposed amendments also address amendments to authorizations, requirements to inform the Minister of foreign authorization/licence revocation or suspension, and fee requirements and exemptions. Health Canada’s consultation on the proposed amendments closed on April 13, 2023.

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