The Order Amending the Fees in Respect of Drugs and Medical Devices Order (Medical Devices for an Urgent Public Health Need), registered as SOR/2023-278 initiated under the Food and Drugs Act amendments the regulatory framework for medical devices designated for urgent public health needs (UPHN), particularly in light of potential public health emergencies beyond COVID-19.

A significant change in the order is the introduction of an exception (1.1) for applications amending authorizations for medical devices. This exception allows for amendments related to medical conditions that qualify the device as a UPHN medical device when the application is submitted, providing crucial flexibility for manufacturers to respond promptly to public health needs without incurring fees during the amendment process.

The order also revises several provisions related to Class II medical devices and the associated fee structures. Specifically, applications for amending licenses or authorizations for Class II medical devices that are not UPHN devices will now have distinct fee requirements. This change underscores the government’s intention to streamline the application process while maintaining oversight and revenue collection from devices that are no longer deemed necessary for urgent public health.

References to COVID-19 medical devices are being replaced with the broader term medical devices throughout the order. This change aligns with the government’s strategy to prepare for future public health emergencies by establishing a more comprehensive framework for medical devices. The broadening of this definition allows the Minister of Health the authority to add new medical conditions to the UPHN list based on public health risks, thereby enhancing responsiveness to emerging threats.

The primary objective of these amendments is to ensure that Health Canada can impose applicable fees once a medical device is no longer listed on the UPHN list, ensuring fiscal responsibility while managing urgent health needs. The fee structure will continue to exempt devices while they are on the UPHN list, supporting manufacturers in maintaining access to necessary medical technologies without immediate financial burden. Fees will be applied to Class II to IV medical devices once they are removed from the UPHN list, requiring authorization holders to pay examination fees for amendments and an annual right to sell fee. However, if a device authorized for multiple conditions is removed from the UPHN list, fees will apply only once it is entirely removed from all relevant conditions. This structure allows manufacturers to adapt their products in response to shifting public health needs.

Canada (SOR2023/278) January 17, 2024