Right to Sell Annual Fee of CAD 460 for Licensed Devices

1. Key takeaways

After obtaining an MDL, the holder must pay the Right to Sell annual fee each year. As of April 1, 2026, the fee is CAD 460 (CAD 452 in 2025). It applies to licensed Class II, III or IV devices and to authorised Class II, III or IV devices that are not UPHN devices; UPHN devices are not subject to the fee.

• The fee obligation arises every year for each licensed Class II to IV device, so annual cost scales with the size of the licence portfolio.
• Section 77(2) of the fee order defines who pays, tied to whether the licence is suspended under sections 40 or 41.
• UPHN devices are expressly excluded from the fee, a cost difference that follows the emergency authorisation path.
• The right-to-sell fee for MDL holders and the annual review fee for MDEL holders are separate obligations with different amounts and legal bases.
• The rate changed from CAD 452 in 2025 to CAD 460 in 2026, and the new rate applies from April 1, 2026.

2. Legal basis

The fee, who must pay it and the exclusion for UPHN devices all come from the fee order and the supporting Health Canada pages, summarised below.

The fee sits at the intersection of the device licence system and the fee order: the licence determines that a device exists in the Class II to IV space, and section 77 converts each such device into an annual payment obligation with defined payer rules and a defined exclusion.

3. Expert insights

Insight 1: the payer is tied directly to whether the licence is suspended.

Under section 77(2), the fee is payable by the licence holder for a Class II, III or IV device (on the condition that the licence has not been suspended under sections 40 or 41 of the Medical Devices Regulations), or by the authorisation holder. Where the licence is suspended, the payer rules change accordingly. A company managing licences that could be suspended should therefore review the payer position whenever a suspension occurs, rather than assuming the invoicing arrangement carries over unchanged through the suspension period. Making this review a standing step in the suspension playbook costs nothing in normal years and closes the gap that opens the moment a suspension notice arrives mid-cycle.

Insight 2: UPHN devices are expressly excluded.

Section 77(1) applies to “licensed Class II, III or IV devices, or authorised Class II, III or IV devices that are not UPHN devices”. Read in reverse: UPHN devices are not subject to the right-to-sell annual fee. This is a cost difference attached to the emergency authorisation path. Companies holding authorised devices should therefore split their portfolio between licensed devices, which carry the annual fee, and UPHN devices, which do not, before building the annual budget rather than applying the fee uniformly across everything they hold. Getting this split right at the start of the budget cycle is far easier than unpicking it during finance review, when the mixed figures have already flowed into forecasts and reports.

Insight 3: the per-device basis of the fee means the portfolio size directly determines annual cost.

The annual fee covers the right to sell an individual licensed or authorised Class II to IV device. The more device licences a company holds, the more the annual cost accumulates device by device. Multi-product companies should build an annual cost model on the basis of the number of licences multiplied by CAD 460, and should treat portfolio pruning as a cost lever: every licence retained for a product that no longer ships is a recurring fee with no offsetting revenue.

Insight 4: the MDEL annual fee is a separate line.

The right-to-sell annual fee for MDL holders (CAD 460) and the annual review fee for MDEL holders (CAD 5,519) differ in payer, legal basis and amount, and must be budgeted and calendared separately. Although both run annually and both effectively cluster around the April 1 rate switch, they are not interchangeable items, and merging them into a single compliance line is a common source of budget confusion. The cleanest structure is two named recurring items in the compliance calendar, each with its own owner, its own legal reference and its own amount, reviewed together once a year but never netted or combined in reporting.

4. Practical recommendations

• Build the annual cost model on the number of licences multiplied by CAD 460, covering all Class II to IV licences.
• Exclude UPHN authorised devices from the right-to-sell fee budget.
• Set the calendar alongside the MDEL ALR (before April 1), but keep the two budget lines separate.
• Review the payer rules of section 77(2) whenever a licence is suspended.
• Verify the new year’s rate around April 1 each year.

5. Verification checklist

• □ The annual right-to-sell fee model is built per licence (CAD 460 per device)
• □ UPHN authorised devices are excluded from the right-to-sell fee budget
• □ The right-to-sell fee and the MDEL annual review fee are separate budget lines
• □ The payer rules in a licence suspension scenario have been reviewed
• □ An annual rate check around April 1 is in place
• □ Proof of payment is archived

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