Health Canada has updated its fees effective April 1, 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 Fees Effective April 1, 2026
For medical devices, Health Canada uses a combination of annual and application-based fees. Therefore, the fee updates, effective April 1, 2026, affect companies in different ways depending on whether they are maintaining an existing licence or submitting new applications or amendments.
Medical Device Application and Establishment Licence Fees
Health Canada charges application-based fees when companies submit new licence applications, amendments, or establishment licence applications. These fees are triggered by regulatory activity rather than charged annually.
For companies that manufacture, import, or distribute medical devices, an establishment licence is required. Health Canada has confirmed the following update effective April 1, 2026:
| Fee Category | Fee as of April 1, 2025 | Fee as of April 1, 2026 |
| Medical Device Establishment Licence application | $5,426 | $5,519 |
Health Canada also applies fees for examining applications for medical device licences, as well as amendments to licences or authorizations. These fees vary based on device class and the nature of the change:
| Item | Category | Fee as of April 1, 2025 | Fee as of April 1, 2026 |
| 1 | Applications for Class II licence | $632 | $643 |
| 2 | Class II licence amendment or amendment to authorization | $325 | $331 |
| 3 | Applications for Class III licence | $13,926 | $14,163 |
| 4 | Class III licence for near patient in vitro diagnostic device | $29,664 | $30,169 |
| 5 | Class III licence amendment related to manufacturing changes | $4,395 | $4,470 |
| 6 | Class III licence amendment for significant changes not related to manufacturing | $11,178 | $11,369 |
| 7 | Applications for Class IV licence | $30,199 | $30,713 |
| 8 | Class IV licence amendment related to manufacturing changes | $4,395 | $4,470 |
| 9 | Class IV licence amendment for significant changes not related to manufacturing | $15,979 | $16,251 |
| 10 | Class II, III, or IV licence or amendment for private label medical devices | $176 | $179 |
Right to Sell Fees for Medical Devices
The annual Right to Sell fee applies to companies that hold a valid licence or authorization for Class II, III, or IV medical devices in Canada. This fee is charged each year, regardless of whether changes are made to the licence.
As explained by Health Canada in its guidance on the fee for the right to sell licensed medical devices, the annual fee will increase as of April 1, 2026:
| 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 |
This fee applies annually to each licence holder and is separate from application, amendment, or review fees. It is separate from application, amendment, or review fees and applies on an ongoing basis for as long as the licence remains active.
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 |
These updated fees are particularly relevant for companies managing multiple product changes, lifecycle updates, or post-market submissions.
Annual Right to Sell Fees for Drugs
In addition to submission and application review fees, drugs authorized for sale in Canada are also subject to an annual Right to Sell fee once a Drug Identification Number has been issued. This fee applies each year for as long as the drug remains authorized for sale, regardless of whether changes are made to the product.
As outlined by Health Canada in its guidance on fees for the right to sell drugs for human use, the following annual fees will apply as of April 1, 2026:
| Drug Category | Fee as of April 1, 2026 |
| Disinfectant | $1,760 |
| Non-prescription drug | $3,391 |
| Drug other than disinfectant or non-prescription drug | $5,626 |
These fees apply per DIN and represent an ongoing regulatory cost that companies should factor into long-term planning.
Cannabis Application Screening Fees
Health Canada fees for 2026 include updated application screening fees for cannabis licences. These fees apply only to the review of a licence application and are charged at the time an application is submitted. They are separate from ongoing regulatory and licensing costs.
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 |
Health Canada specifies that these screening fees are not subject to remission and are payable regardless of the outcome of the application.
Additional Cannabis Regulatory Fees to Consider
In addition to application screening fees, cannabis licence holders are responsible for several other regulatory costs that are not included in the amounts above.
- Individual security clearances are required for key personnel. The current fee is $2,041 per person, and future adjustments are expected to follow the same annual fee update process applied across other Health Canada programs.
- Annual regulatory fees apply once a licence is issued. At a minimum, the current annual fee is $2,500 for microlicences and $23,000 for standard operations, in addition to any application screening fees.
Taken together, these fees mean that cannabis licensing costs extend well beyond the initial application review and should be factored into both short-term budgeting and long-term operational planning.
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
- 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.
