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Canada Medical Device Registration Fees
Health Canada government fees for 2025
CAD 632
Low Risk Min
CAD 30,199
High Risk Max
Health Canada
Authority
2025-12-16
Last Updated
Canada (Health Canada) Fee Overview
Health Canada fees are based on device class and licensing pathway. Class II devices pay approximately CAD 466 (~$350), while Class III/IV devices range from CAD 4,592-15,640 (~$3,400-$11,600). 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 632 | Per application |
MDL Application - Class III | CAD 13,926 | Per application |
MDL Application - Class III IVD | CAD 29,664 | Per application |
MDL Application - Class IV | CAD 30,199 | Per application |
Establishment Licence (MDEL) | CAD 5,426 | Per establishment |
Annual Right to Sell Due November 1st each year | CAD 452 | Annual |
Key Facts About Health Canada Fees
- 1Class II: CAD 466 per license
- 2Class III: CAD 4,592 per license
- 3Class IV: CAD 15,640 per license
- 4MDSAP accepted for QMS
- 5Establishment License required
Important Notes
- •Class II: Lower fee tier
- •Class III/IV: Higher fee tier
- •Annual right-to-sell fee applies to all classes
- •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: 2025-12-16. Always verify current fees with Health Canada.