Update: Amendments to the Medical Devices Regulations came into force on January 3, 2024 substantially as proposed: Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (see also Health Canada’s notice and guidance).
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:
- allow the Minister of Health (Minister) to add a medical condition to the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 where specific criteria are met;
- allow for the inclusion of additional medical conditions on the List of Medical Devices for Expanded Use in Relation to COVID-19 (and any other relevant provisions) when necessary; and
- allow the Minister to issue an authorization even if the UPHN status of a device changes after a manufacturer submits an application for authorization in respect of that device.
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.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.