Medical Device Establishment Licence Review Fee of CAD 5,519

1. Key takeaways

The establishment licence (MDEL) review fee is CAD 5,519 as of April 1, 2026 (CAD 5,426 in 2025). The fee is charged for a first MDEL, a subsequent annual licence and MDEL reinstatement, and applies equally to foreign and domestic establishments. Some categories of persons are exempt from the MDEL fee.

• The 2026 rate of CAD 5,519 replaced the 2025 rate of CAD 5,426, continuing the pattern of annual adjustment.
• One fee covers three scenarios: the first licence, the annual licence that follows, and reinstatement after lapse.
• Foreign and domestic establishments pay the same rate; location does not change the fee.
• Whether a fee arises at all depends first on whether an MDEL is required, since exemptions under section 44 remove the licensing duty.
• For portfolios of Class I devices the MDEL fee is the dominant official cost, while for Class IV devices the MDL application fee dominates.

2. Legal basis

The fee amount, the fee scenarios, the exemption rule and the fee order behind them are summarised in the table below.

The two questions this fee raises, whether an establishment needs an MDEL and how much the MDEL costs per year, are answered by different instruments: the Regulations decide the first, the fee publications decide the second, and a budget is only correct when both have been answered in sequence.

3. Expert insights

Insight 1: equal treatment of foreign and domestic establishments is an explicit feature of Canadian fee design.

The Health Canada fees page states in its own words that these fees “are applied equally to foreign and domestic establishments”. Foreign companies cannot expect differential treatment on rates. When comparing the cost of entering Canada against other jurisdictions, this should be read as a deliberate design choice rather than an accident of drafting: the regulator prices the licence by the activity of distribution and import, not by where the company happens to be organised, and no foreign-establishment surcharge or discount exists on this line. Budget models built for other markets therefore need no location-based adjustment when they are extended to Canada; the same rate line applies wherever the establishment sits.

Insight 2: reinstatement is the fee scenario most often missed in budgets.

A first application, a subsequent annual licence and reinstatement are each charged at CAD 5,519. When companies build three-year budgets, the reinstatement scenario should be included as a scenario line. It is not a remote possibility: reinstatement becomes relevant exactly when maintenance obligations are missed, which is the kind of event that also consumes management attention, so leaving the fee out of the plan doubles the pain of a lapse instead of cushioning it. The same logic applies to scenario planning generally: a contingency line that never gets used is cheap insurance, while an unbudgeted reinstatement lands on finance at the same time as the remediation work it accompanies.

Insight 3: the fee and the question of whether an MDEL is needed at all are two separate questions.

Under section 44(4), a foreign manufacturer is exempt from the MDEL where it imports through a person holding an MDEL or imports directly from a Class II to IV manufacturer; what is exempted is the duty to hold the licence, and with it the fee naturally does not arise. From December 14, 2026, foreign distributors selling through licensed importers are likewise exempt. The correct analytical order is therefore to settle the licensing question first and the fee question second, because the fee only exists for establishments that actually need the licence.

Insight 4: the MDEL fee and the MDL fee are different orders of magnitude.

The MDEL is CAD 5,519 against a Class II MDL application of CAD 643. For companies dealing only in Class I devices, the MDEL fee is the main official cost item; for companies dealing in Class IV devices, the MDL application fee of CAD 30,713 dominates. The budget structure therefore follows the product portfolio, and the same company can flip its dominant cost item simply by changing the class mix of what it sells. Reviewing that mix annually alongside the April 1 rate adjustments keeps the dominant-item analysis aligned with both the portfolio and the current fee schedule rather than with a snapshot taken at market entry.

4. Practical recommendations

• Budget CAD 5,519 across the three scenarios: first application, annual licence and reinstatement.
• Budget foreign establishments at the same rate, without expecting a rate difference.
• First determine whether an MDEL is needed (the section 44(4) exemption), then decide whether the fee arises.
• Let the product portfolio decide the dominant budget item: mostly Class I means the MDEL; mostly Class IV means the MDL application fee.
• Verify the new year’s rate around April 1 each year.

5. Verification checklist

• □ The applicable annual rate is confirmed (CAD 5,519 as of 2026-04-01)
• □ The budget covers the first, annual and reinstatement scenarios
• □ Foreign establishments are budgeted at the same rate
• □ Whether an MDEL is needed has been determined (applicability of the section 44(4) exemption)
• □ The dominant budget item has been set according to the product portfolio
• □ An annual rate check around April 1 is in place

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