🇨🇦
Canada Medical Device Registration Fees
Health Canada government fees for 2026
CAD 643
Low Risk Min
CAD 30,713
High Risk Max
Health Canada
Authority
2026-01-12
Last Updated
Canada (Health Canada) Fee Overview
Health Canada fees are based on device class and licensing pathway. Class II devices pay approximately CAD 643 (~$475), while Class III/IV devices range from CAD 14,163-30,713 (~$10,500-$22,700). Canada accepts MDSAP certification for QMS compliance, which can streamline the registration process for manufacturers already certified.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
MDL Application - Class II | CAD 643 | Per application |
MDL Application - Class III | CAD 14,163 | Per application |
MDL Application - Class III (near patient) | CAD 30,169 | Per application |
MDL Application - Class IV | CAD 30,713 | Per application |
Establishment Licence (MDEL) Class I only | TBD | Annual |
Annual Right to Sell Class II/III/IV | TBD | Annual |
Key Facts About Health Canada Fees
- 1Class II: CAD 643 per license
- 2Class III: CAD 14,163 per license
- 3Class III (near patient): CAD 30,169 per license
- 4Class IV: CAD 30,713 per license
- 5MDSAP accepted for QMS
- 6Establishment License required
Important Notes
- •Class II: Lower fee tier
- •Class III/IV: Higher fee tier
- •Annual right-to-sell fee applies to Class II/III/IV
- •Fees adjusted annually for CPI
Tips for Canada Registration
- 1MDSAP can substitute for facility audits
- 2Prepare Canadian labeling requirements early
- 3Device licenses do not expire but require amendment for changes
Frequently Asked Questions
Related Resources
Government fees are subject to change. Last data update: 2026-01-12. Always verify current fees with Health Canada.