Home » Canada Increases Device User Fees, Agency Under the Gun for Missing Goals
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. 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
International Medical Device Regulatory Monitor
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