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Canada Increases Device User Fees, Agency Under the Gun for Missing Goals

May 18, 2012
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. License processing fees for Class III devices and IVDs are $5,173 and $8,809, respectively. Manufacturers of Class II devices pay $359 per application.
International Medical Device Regulatory Monitor