On January 3, 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (the "Amended Regulations") came into force. They were accompanied by new Guidance on Medical devices for an urgent public health need ("UPHN Guidance").
The Amended Regulations and UPHN Guidance enable access to the expedited authorization pathway for a medical device that addresses a public health need without relying on temporary measures.
i. Context
On February 22, 2023, Health Canada introduced 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). This accelerated access to COVID-19 medical devices that addressed an urgent public health need in Canada, such as testing kits and ventilators.
Upon coming into force of the Amended Regulations, the interim order was archived.
ii. New Regulations & Guidance
The Amended Regulations expand the scope of the urgent public health need beyond COVID-19, to apply to any medical condition for which the Minister has reasonable grounds to believe that it presents, or is the result of, a significant risk to public health in Canada and requires immediate action to deal with the risk.
More specifically, the Amended Regulations apply to medical devices for which there is an urgent public health need to diagnose, treat, mitigate or prevent these medical conditions. The UPHN Guidance then provides direction as to the authorization, post-market requirements and cancellation of such medical devices.
Part 1.1 of the Medical Devices Regulations (MDR) now provides an expedited authorization pathway for:
- new medical devices that are on the List of Medical Devices for an Urgent Public Health Need (UPHN list) and that are not licensed or authorized for importation or sale in Canada;
- expanded use indications added by the Minister to the List of Medical Devices for Expanded Use (expanded use list) for existing devices licensed or authorized under the MDR; and
- medical devices that are on the UPHN list and leverage an authorization of a device from a regulatory agency that is on the List of Regulatory Agencies for the Purposes of Subsection 68.11(4) of the Medical Devices Regulations
An urgent public health need exists if immediate action is required to protect or improve the health of individuals or communities in Canada. The UPHN Guidance indicates that, in order to determine whether there is an urgent public health need, Health Canada considers several factors, including:
- the supply and demand of the medical device or a similar device to it
- the device lifecycle (how long it lasts)
- the clinical need for the device in diagnosing, treating, mitigating or preventing the corresponding medical condition on the UPHN list
- the status of the public health emergency in Canada
- the status of domestic emergency preparedness
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