Canada raises regulatory fees for medical devices

23 May 2019

Health Canada, the regulator for human and veterinary drugs and medical devices, has raised its fees for the regulation of devices and drugs to reflect the complexity and costs of the work involved. Fees will be set at 50% to 100% of costs, which will be phased in between four and seven years. From April 2021, fee increases will be linked to the Consumer Price Index and will be adjusted annually. The final fee schedule reflects a compromise following pushback from the industry of higher fees. The revised fees will come into effect in April 2020.  

In the mid-nineties, Health Canada introduced fees for regulatory activities charged to industry, consistent with other international regulators. In Budget 2017, the government of Canada stated that “businesses should pay their fair share for the services the Government provides.” From October 2017 to January 2018, Health Canada engaged in consultation on their fee proposal for drugs and medical devices, which aimed to update fees to better reflect current costs.

A number of concerns were raised by stakeholders during this consultation. These included the magnitude of the fee increases, the lack of staggered implementation, and the proposed approach to small business. For these reasons, Health Canada made a number of revisions. Moving forward, Health Canada will be meeting annually with stakeholders to discuss key elements of cost recovery including performance, costs and programme efficiencies.



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