Device User Fees Tip Up in Canada, Agency Criticized for Missed 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, according to a recent Health Canada guidance.
Devices & Diagnostics Letter