Health Canada Medical Device Licence Application Fees for 2026

1. Key takeaways

As of April 1, 2026, Health Canada’s MDL application fees are: Class II CAD 643, Class III CAD 14,163, Class III near-patient IVD CAD 30,169, Class IV CAD 30,713; amendment applications are tiered by class and by the nature of the change; private label devices CAD 179 (regardless of class).

• The 2026 fee schedule takes effect on April 1, 2026, replacing the rates that applied from April 1, 2025.
• Near-patient Class III IVDs are priced almost at Class IV level, not at the ordinary Class III level.
• Amendment and authorisation amendment fees are split between manufacturing-related and significant non-manufacturing changes, with Class IV highest.
• The private label fee item applies to Class II, III and IV alike and is the lowest-cost path among the four categories.
• Fees are adjusted annually, and April 1 is the switch date for determining which year’s rate applies.

2. Legal basis

The fee amounts are published by Health Canada and anchored in the fee order. The two governing sources are listed below, followed by the full fee table.

Fee schedule (as of April 1, 2026, in Canadian dollars)

Every fee item increased between the two columns of the table, so a budget built on the previous year’s figures will systematically undershoot the amounts actually due after April 1.

3. Expert insights

Insight 1: the near-patient IVD fee item sits close to Class IV.

The Class III near-patient IVD fee of CAD 30,169 differs from the Class IV fee of CAD 30,713 by only CAD 544. This closeness indicates that the review resource commitment for such an application should be estimated at the Class IV scale, not at the ordinary Class III scale of CAD 14,163. Companies classifying a near-patient IVD that assume the ordinary Class III budget will be out by more than a factor of two, which is large enough to derail project approvals if it surfaces late in planning. The fee schedule is therefore also a useful signal of review intensity: where the regulator prices a category close to the top tier, planning the submission effort at that tier is the safer assumption.

Insight 2: amendment fees are tiered by whether the change is manufacturing related, and Class IV is highest.

The Class IV significant non-manufacturing change fee is CAD 16,251, while the manufacturing-related fee is CAD 4,470, a gap of nearly 3.6 times. Change management should therefore complete a characterisation of the change, and an assessment of the resulting fee, before implementation. Leaving the classification to the point of filing risks discovering that a change assumed to be minor falls into the expensive tier, at which point the project economics may need to be revisited rather than merely the budget line adjusted.

Insight 3: the private label fee item is not class-specific and is the cheapest path among the four categories.

Private label devices are set at CAD 179, and the item applies across Class II, III and IV. Its precondition is that the device is identical in every respect to a licensed device. Where that precondition genuinely holds, the fee difference against a standard application is so large that verifying eligibility for the private label route becomes a financial exercise in its own right, and documenting that verification protects the fee position if the choice is later questioned.

Insight 4: fees are adjusted annually, and April 1 is the switch date.

The comparison between the two columns of the table above shows upward adjustment in every fee item from one year to the next. Projects that cross April 1 must confirm the applicable year’s rate at the time of submission, because the filing date, not the project start date, determines the amount payable. For programmes running across multiple submissions, the cleanest approach is to date-stamp every budget line with the fee year it assumes and to re-verify the schedule each April, so that a rate change never arrives as a surprise inside an already-approved project plan.

4. Practical recommendations

• Build budgets on the tiers effective from April 1, 2026, and leave room for the following year’s increase.
• Budget near-patient IVDs at CAD 30,169, and do not use the ordinary Class III tier.
• In change management, complete the manufacturing-related versus non-manufacturing characterisation before deciding, and assess the fee accordingly.
• For the private label path, first verify the identity of the device against the licensed device, then budget at CAD 179.
• For submissions that cross April 1, confirm the applicable annual rate before paying.

5. Verification checklist

• □ The applicable year (from 2026-04-01) has been confirmed
• □ The correct fee item has been selected by class, including the near-patient IVD and private label determinations
• □ Change fees have been assessed according to whether the change is manufacturing related
• □ The budget leaves room for the following year’s increase
• □ Submissions crossing April 1 have confirmed the applicable rate
• □ Both the Health Canada fees page and SOR/2019-124 have been checked

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Canadian market. Our team manages Health Canada Medical Device Licence and MDEL applications, prepares risk-classified dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com