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Medical Devices / Regulatory Affairs

Canada Details New User Fees for Device Sponsors

May 28, 2019
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Health Canada is increasing fees for device sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. 

Under rules to be phased in over four years from Apr. 1, 2020, device sponsors will have to pay 75 percent of costs for pre-market evaluations, 67 percent of right to sell applications and 100 percent for establishment licenses, the agency said in its 50-page report.

“Currently, Health Canada fees are not reflective of the costs to deliver its regulatory programs,” the agency said. “New regulatory challenges stemming from increasingly complex submissions; greater risks from counterfeit or contaminated products; and increased volume of products imported into Canada means Health Canada must adapt in order to continue maintaining the effective and efficient delivery of its regulatory activities.”

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