Fee Reduction Arrangements for Qualifying Small Businesses in Canada

1. Key takeaways

Canada has fee reduction arrangements for qualifying small businesses. Based on the material available, the reductions include free first pre-market reviews, reduced fees for subsequent reviews and reduced right-to-sell fees; however, the specific thresholds and reduction percentages must be confirmed against Health Canada’s official fee reduction page. This series lists the specific thresholds as pending verification and does not present unverified figures in the body text.

• What is verifiable today is that a reduction mechanism exists within the fee system established under the fee order.
• The specific employee-count or revenue thresholds and reduction percentages are pending verification and are deliberately not stated as numbers here.
• Reduction arrangements are typically layered by whether the review is a first review and by fee type.
• Eligibility determination is generally required before submission, as a practical estimate of how the process works.
• Commercial documents should only quote reduction figures after official written confirmation has been obtained.

2. Legal basis

The verified sources behind this topic are limited, which is itself the point of this article: the table below shows what is confirmed, what governs the fees, and which item remains on the unverified list.

The third row is included not as a source of figures but as a disclosure: the material circulating in the industry on thresholds and percentages has not been traceable to an official source in this verification round, and it is therefore marked rather than quoted.

3. Expert insights

Insight 1: what can be verified is that a reduction mechanism exists; what cannot be verified is the specific thresholds.

What this series was able to confirm in verification is that the Health Canada fee system is established under the Order Setting Out the Fees Payable for Drugs and Medical Devices (SOR/2019-124), and that the official fees page did not, in this verification round, provide small business threshold figures that could be quoted verbatim. This article therefore states only that a reduction arrangement exists and lists the specific figures as pending verification. That restraint is not pedantry; it is what keeps the article citable, because a number attributed to an unverifiable source propagates the problem to everyone who relies on it. Readers who need the actual thresholds for a live project should go to the official fee reduction page directly and treat whatever they find there, dated and saved at that moment, as the only usable figure.

Insight 2: reductions are typically layered by whether the review is a first review and by fee type.

According to industry compilations, reduction arrangements are set separately for first pre-market reviews, subsequent reviews and right-to-sell fees. This layered design is structurally similar to the small business mechanism under MDUFA in the United States, which sets thresholds by total revenue and treats first PMAs separately, but the specific conditions must be verified separately for each jurisdiction. Structural similarity is not evidence of identical numbers, and the two systems should not be read across.

Insight 3: unverified items are not written into the body text; that is the verification discipline of this series.

Under the verification SOP of section 8 of Plan 01, data for which an official source cannot be located must be marked as a practical estimate, pending verification, and industry articles are barred from standing in for statutes or official data. This article follows that discipline. The practical consequence for readers is a clear boundary: everything above the line of official sources can be acted on, and everything below it must be confirmed before it enters a contract, a budget that will be audited, or a submission. Teams that internalise this boundary stop arguing about individual numbers and start arguing only about sources, which is the shorter and more productive conversation.

Insight 4: eligibility determination generally has to be completed before submission.

Similar to small business qualification under MDUFA in the United States, fee reductions in Canada in practice generally require the eligibility determination to be completed before the application is submitted, and eligibility does not reach back to fees already paid. This is stated as a practical estimate, pending verification, and the official rules prevail. Treating it as an estimate means building the submission timeline so that the determination happens before filing, without ever relying on retroactive relief in the budget.

4. Practical recommendations

• At the budgeting stage, confirm the current small business reduction conditions and percentages through official Health Canada channels.
• Treat the reduction application as a separate work item that runs in parallel with the MDL application, not in series.
• Complete the eligibility determination before the first submission, so that fees already paid are not stranded without relief.
• Even with a reduction expected, prepare a full-amount budget version as the contingency scenario if the reduction is not granted.
• Only quote reduction figures in tender documents and commercial quotations after official written confirmation has been obtained.

5. Verification checklist

• □ Current small business reduction conditions and percentages have been confirmed through official channels (the pending verification item is closed)
• □ The reduction application is scheduled as a separate work item
• □ Eligibility determination is completed before the first submission
• □ A full-amount budget has been prepared as the contingency scenario without the reduction
• □ Commercial quotations do not cite unverified reduction figures
• □ Official written confirmation 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