FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Health Canada Proposes Streamlined Process for Priority Review Requests

Dec. 6, 2018
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Health Canada is proposing a new streamlined priority review request mechanism that would significantly reduce burdens on devicemakers.

Under the proposal, devicemakers would be able to request a priority review when they submit device license applications, so a separate priority review request would no longer be required.

The agency previously issued an interim policy for priority review applications in 2000, which prioritized Class III or Class IV device applications intended to diagnose or treat serious, life-threatening or severely debilitating conditions.

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