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FDAnews Device Daily Bulletin

Canada Proposes Significant Hike in User Fees for Devices

Oct. 20, 2017

Health Canada has proposed fee hikes for reviewing medical devices, as well as licensing and postmarket surveillance and enforcement activities.

Fees, last revised in 2011, fall short of the agency’s new goal of covering 90 percent to 100 percent of costs, Health Canada said.

The department “faced with an increased volume of work as well as added complexity from globalization, technological advancement and more sophisticated data and systems,” it said.

Some of the proposed new fees are dramatically higher than current fees.

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