Taking effect April 1st, 2019, Health Canada will be implementing the established annual 2% increase in human drug and medical device fees for the fiscal year 2019 – 2020. Additionally, current veterinary drug fees will increase by the Consumer Price Index (2.2%).
Following a notice of fee changes published in the Canada Gazette, related guidance documents and application forms are to be updated to reflect the adjusted fees and published on the Health Canada website.
In order to market their devices in Canada, manufacturers must obtain a license. The review of Medical Device Licence Applications (new licence), the requests for the reinstatement of an existing licence, as well as the amendment of a current medical device licence are subject to fees.
The applicable fees for the fiscal year 2019-2020, expressed in Canadian dollars, are reported in the table below:
| Category | Fee |
| Class II – New licence application | $414 |
| Class III – New licence application | $5,922 |
| Class III – New licence application for a near patient in vitro diagnostic device | $10,079 |
| Class III – Amendment application – a significant change that relates to manufacturing | $1,492 |
| Class III – Amendment application – a significant change or change that would affect the Class of the device that is not related to manufacturing | $5,546 |
| Class IV – New licence application | $13,770 |
| Class IV – New licence application for devices that contain human or animal tissue | $12,846 |
| Class IV – New licence application for a near patient in vitro diagnostic device | $23,473 |
| Class IV – Amendment application – a significant change that relates to manufacturing | $1,492 |
| Class IV – Amendment application – a significant change or change that would affect the Class of the device that is not related to manufacturing | $6,319 |
