Canada: Health Canada Proposing Fee Increases for Medical Device License Applications

Health Canada has opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies.

The proposal includes raising Medical Device License (MDL) application fees by nearly 60% for Class II devices and by more than double for Class III devices.

In addition, it is proposed that fees associated with the Medical Device Establishment Licencing (MDEL) required for low-risk Class I devices would decrease by nearly half.

The proposal would also give new authority to Health Canada to withdraw or withhold service or approval if a fee is not paid, and all fees moving forward would be collected before reviews begin or licenses are issued.

To see all of the fee changes, please see Health Canada – Consultation. Comments are due 4 January 2018.