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FDAnews Device Daily Bulletin
May 30, 2012 | Vol. 9 No. 106
Canada Increases Device User Fees, Agency Under the Gun for Missing Goals
User fees for medical device license and renewal rose 2 percent in Canada, effective April 1. Devicemakers must now pay US $12,036 for a Class IV device application and $20,519 for a Class IV near-patient in vitro diagnostic device (IVD) application. Fees for Class IV license amendments are $5,522 for a significant change and $1,301 for a minor one, a recent Health Canada guidance states.
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