FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Canada’s MEDEC Says Proposed Fee Hikes Are Unjustified, Bad for Business

Feb. 14, 2018

Canada’s medtech association MEDEC said Health Canada’s proposed fee increases could have a significant negative impact on industry, economic growth, and ultimately patient care.

The association said it was disappointed that the proposal failed to mention further ways  the regulator could leverage outcomes and evidence to reduce duplication and improve review time, particularly when the increased fees won’t be coupled with better performance standards.

MEDEC said the steep increases for devices are not justified, particularly when most increases amount to more than 100 percent. For example, a license application for a Class III medical device would increase from $5,691 (US$4,528) to $13,861 (US$11,029). A Class III device application for a near-patient in vitro diagnostic device would increase from $9,687 (US$7,708) to $32,267 (US$25,675).

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