Health Canada has updated its fees for 2026, with changes applying across multiple regulated sectors, including medical devices, drugs, and cannabis. The updated fees reflect the federal government’s annual adjustment process and affect both recurring regulatory charges and one-time submission costs. For companies preparing submissions or renewals in the coming year, understanding how Health Canada fees in 2026 apply to your specific regulatory pathway is essential for budgeting, compliance planning, and avoiding delays. Health Canada updates its fees each year under the Service Fees Act to account for inflation and the cost of delivering regulatory programs. While the increases are typically incremental, they apply automatically and affect a wide range of regulated activities. As a result, organizations that do not factor these annual updates into their regulatory planning often face unexpected cost increases once an application or submission is filed. The sections below outline the confirmed changes and where businesses are most likely to see cost impacts. Keep reading to learn more. Medical Device Right to Sell Fees Effective April 1, 2026
For medical device manufacturers and distributors, the 2026 update to Health Canada fees includes an increase to the annual fee for the right to sell licensed or authorized Class II, III, or IV medical devices in Canada. As explained by Health Canada in its guidance on the fee for the right to sell licensed medical devices, the annual fee for devices that are not classified as urgent public health need medical devices will change as follows:| Fee Category | Fee as of April 1, 2025 | Fee as of April 1, 2026 |
| Right to sell Class II, III or IV medical devices | $452 | $460 |
Drug Submission and Application Review Fees
Revised Health Canada fees for 2026 also affect pharmaceutical submissions for drugs for human use. These fees apply per submission and vary based on the type of data provided and the regulatory activity involved. According to Health Canada’s pharmaceutical submission and application review fee schedule, the following fees will apply as of April 1, 2026:| Item | Submission Class | Fee as of April 1, 2025 | Fee as of April 1, 2026 |
| 1 | New active substance | $606,286 | $616,593 |
| 2 | Clinical or non-clinical data and chemistry and manufacturing data | $313,944 | $319,282 |
| 3 | Clinical or non-clinical data only | $125,533 | $127,668 |
| 4 | Comparative studies | $70,750 | $71,953 |
| 5 | Chemistry and manufacturing data only | $43,529 | $44,269 |
| 6 | Clinical or non-clinical data only in support of safety updates to labelling | $22,977 | $23,368 |
| 7 | Labelling only | $6,328 | $6,436 |
| 8 | Labelling only for generic drugs | $2,378 | $2,419 |
| 9 | Administrative submission | $1,002 | $1,020 |
| 10 | Disinfectant full review | $13,186 | $13,411 |
| 11 | Labelling only for disinfectants | $2,964 | $3,015 |
| 12 | Drug identification number application labelling standards | $1,912 | $1,945 |
Cannabis Application Screening Fees
In 2026, Health Canada fees will also include higher application screening fees for cannabis licences. These fees apply at the time of submission and are separate from annual regulatory charges. As outlined in Health Canada’s report on cannabis licensing fees, the following screening fees will apply starting April 1, 2026:| Licence Type | 2024 to 2025 Fee | 2026 to 2027 Fee |
| Micro-cultivation | $1,969 | $2,058 |
| Standard cultivation | $3,933 | $4,109 |
| Nursery | $1,969 | $2,058 |
| Micro-processing | $1,969 | $2,058 |
| Standard processing | $3,933 | $4,109 |
| Sale for medical purposes | $3,933 | $4,109 |
What These Fee Updates Mean for Your Business
Although each increase may appear modest on its own, updated Health Canada fees for 2026 can significantly affect companies operating across multiple licences, products, or regulatory pathways. In addition, deficiencies during screening or review can lead to delays and added costs. Proactive planning and well-prepared submissions remain key to managing both timelines and regulatory expenses.Key Takeaways
- Updated Health Canada fees for 2026 apply across medical devices, drugs and cannabis
- Medical device right to sell fees increase effective April 1 2026
- All drug submission categories include revised review fees
- Cannabis application screening fees increase for all licence types
- Early regulatory planning helps control costs and reduce delays
Frequently Asked Questions About Health Canada Fees 2026
Do higher fees mean faster reviews?
No. Health Canada’s fee adjustments are tied to cost recovery under the Service Fees Act and are not linked to service standards or review timelines. Paying a higher fee does not change how quickly a submission or application is assessed.
Are any of these fees optional?
No. Once a submission or licence application is filed, the applicable Health Canada fee becomes mandatory. Fees are required regardless of the outcome of the review and must be paid to proceed with the assessment.
Can smaller companies qualify for reduced fees?
In limited circumstances, fee remissions may be available. However, many screening and submission fees are not eligible for reduction, particularly for cannabis licence applications and certain drug and medical device activities. Eligibility depends on the specific fee and regulatory program rather than company size alone.
Can regulatory support help reduce overall costs?
Yes. While fees themselves cannot be avoided, complete and well-prepared submissions can reduce the likelihood of screening deficiencies, information requests, or resubmissions. Fewer review interruptions can help limit indirect costs associated with delays and repeat filings, an area where experienced regulatory advisors such as Quality Smart Solutions can provide practical support.
Preparing for Health Canada Fees in 2026
As updated fees for 2026 come into effect, careful regulatory planning becomes even more important for companies selling in Canada. Whether you are managing medical device licensing, OTC drug submissions, or cannabis applications, understanding how fees apply to your activities helps you budget accurately and avoid unnecessary setbacks.
If you need support navigating Health Canada requirements or preparing compliant submissions, Quality Smart Solutions is here to help. Feel free to contact us to discuss your regulatory strategy and upcoming obligations.
