We previously reported amendments to Part 1.1 of the Medical Devices Regulations that created a permanent regulatory framework for expediting access to COVID-19 medical devices.
On January 3, 2024, Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) came into force. These regulations broaden the scope of the Part 1.1 regulatory framework beyond COVID-19 to apply to future public health emergencies.
Under the amended framework, the Minister of Health will be able to add any medical condition to the Urgent Public Health Need (UPHN) list if the Minister has reasonable grounds to believe that:
- the medical condition presents, or is the result of, a significant risk to public health in Canada; and
- immediate action is required to deal with the risk.
The Minister will be able to add medical devices or a category of devices to the UPHN list corresponding to a listed medical condition. Manufacturers of listed medical devices will have access to the Part 1.1 regulatory framework and, if authorized, be subject to certain flexibilities, including fee exemptions, until their devices are no longer on the UPHN list.
In addition, on January 3, 2024, an Order Amending the Fees in Respect of Drugs and Medical Devices Order came into force. The Order reflects the amendments made to the regulatory framework to allow the Minister to charge fees once a medical device is no longer on the UPHN list.
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 life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
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