The fees of Health Canada for medicinal products and medical devices are updated annually. Health Canada has informed us of the changes that will come into effect on 1 April 2025 so that our customers can adjust their planning accordingly.
Summary of the changes
Pursuant to the Fees Regulation (Fees in Respect of Drugs and Medical Devices Order) were adjusted for the 2025–2026 fiscal year, including medical device fees, to reflect the 2.7% Consumer Price Index (CPI) increase. Some of these fees will be phased in over seven years and will therefore differ from the values set out in the Fees Regulation. For other regulatory and non-regulatory activities and services, there is an annual fee increase of 2%.
For the financial year 2025–2026, the fees for human and veterinary medicinal products and for medical devices will be adjusted as follows:
| Fee Category | Basis for Adjustment | Annual Adjustment (Fee increase in %) |
| Pre-Market Evaluation, Right to Sell, and Establishment Licence | Consumer Price Index (CPI) | 2,7 |
| Veterinary Drug Dealer’s Licences | Consumer Price Index (CPI) | 2,7 |
| Drug Master Fille | Ministerial Authority | 2,0 |
| Certificate of Pharmaceutical Product | Ministerial Authority | 2,0 |
| Certificate of Supplementary Protection | Certificate of Supplementary Protection Regulations | 2,0 |
| Human Drug Dealer’s Licences | Fees in Respect of Dealer Licences Regulations | 2,0 |
The adjusted fees and updated application forms are already available in the Canada Gazette .
Chances and Challenges
The annual adjustments provide stability and a reliable funding basis for Health Canada's regulatory activities. However, the increasing fees can be a problem, especially for small and medium-sized enterprises (SMEs). This is because entering highly regulated markets such as the Canadian medical device market already involves high regulatory and financial hurdles. For manufacturers operating in narrow margins, a 2.7% fee increase can lead to real problems. In the worst case scenario, the fee increase can prevent market entry for some.
Benefits for small businesses
Fortunately, Health Canada is partially countering this risk. Since April 2020, the agency has been offering special regulations for smaller businesses: companies with less than 100 employees or with an annual gross sale margin between 30,000 and 5 million CAD can benefit from the following reductions:
- Free evaluation for first-time registrations of medicinal products and medical devices prior to market launch.
- 50 % reduction of the fees for pre-market assessment.
- 25 % reduction of the fees for distribution rights.
- 25 % reduction on the fees for establishment licences.
These measures aim to make it easier for small and medium-sized enterprises (SMEs) to access the Canadian market. Further information on these benefits can be found here.
BEO BERLIN welcomes this regulation by the Canadian authorities, because we believe that SMEs are essential for a healthy market. Often, SMEs produce niche products and thus not only contribute to innovation in the market, but also ensure a climate of healthy competition: greater diversity in supply and among producers tends to keep prices low for the end consumer.
The Canadian regulation is a good example of how regulatory authorities can keep the market entry threshold low – and provides a counterexample to the fee increases of the British MHRA.
Our Offer
Do you have any questions about the new fees or do you need assistance with, for example, applying for a Medical Device Establishment Licence (MDEL) or a Medical Device Licence (MDL)? Do you have questions about submitting the Annual Licence Review (ALR) on time?
We at BEO BERLIN are happy to help and support you with all legal and compliance issues for the Canadian market. Contact us!
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