Health Canada current fee schedule, reviewed for 2026, in CAD.
11 fee lines100% exact amountscurrency CADFX rates 2026-09-24reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| MDL Application - Class II | CAD 643 | $456 | Per application | Verified |
| MDL Application - Class III | CAD 14,163 | $10,049 | Per application | Verified |
| MDL Application - Class III near-patient IVD | CAD 30,169 | $21,405 | Per application | Verified |
| MDL Application - Class IV | CAD 30,713 | $21,791 | Per application | Verified |
| Private-label device application | CAD 179 | $127 | Per application | Verified |
| Annual right to sell - Class II/III/IV | CAD 460 | $326 | Annual per licensed device | Verified |
| Medical Device Establishment Licence | CAD 5,519 | $3,916 | Per application; same fee for annual review and reinstatement | Verified |
| Amendment - Class II licence | CAD 331 | $235 | Per amendment | Verified |
| Amendment - Class III/IV changes in manufacturing | CAD 4,470 | $3,171 | Per amendment | Verified |
| Amendment - Class III significant changes not related to manufacturing | CAD 11,369 | $8,066 | Per amendment | Verified |
| Amendment - Class IV significant changes not related to manufacturing | CAD 16,251 | $11,530 | Per amendment | Verified |
Government fees only — service and testing costs are separate- Health Canada fiscal-year fees effective 1 April 2026.
- Application review, amendments, annual right-to-sell, and establishment licensing are separate charges.
- Small businesses (fewer than 100 employees, or annual gross revenues between CAD 30,000 and CAD 5 million including affiliates) receive a 25% reduction; status must be granted before applying and renewed yearly.
- Device fees are adjusted annually (e.g. MDEL rises by the Consumer Price Index each 1 April following a Canada Gazette Notice of Intent).
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Exact amounts verified against the Health Canada fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:canada:mdl-application-class-ii