Are you ready for the upcoming changes to Health Canada Fees in 2025? These fees, effective from April 2025, impact businesses dealing with drugs, medical devices, and cannabis. With updates spanning licensing, submissions, and compliance requirements, staying informed is key to avoiding disruptions.
Health Canada is introducing a phased fee structure that ensures businesses contribute to maintaining high standards for product safety and efficacy. From updated pre-market evaluation fees for drugs and medical devices to regulatory costs for cannabis producers, these changes could affect your budget and planning.
Want to know how these updates might impact your operations? Keep reading to explore the details and learn how to navigate these fees effectively with expert tips from Quality Smart Solutions.
Medical Devices
If you’re in the medical device sector, you will encounter fees tied to your initial Medical Device License (MDL) Application. These fees vary based on the classification of your medical device. The following are the fees for an MDL application as of April 1, 2025:
- Class 2 Devices: $632
- Class 3 Devices: $13,926
- Class 3 Devices (Near Patient): $29,664
- Class 4 Devices: $30,199
Applicable MDL amendments are also subject to additional application fees.
If you wish to apply for a Medical Device Establishment License (MDEL), you will need to pay both the initial application fee and the annual license renewal fee each year. The following are MDEL fees as of April 1, 2025.
- Application for a new MDEL and annual review of license: $5426
Annual fees for right to sell licensed devices also apply. The fee as of April 1, 2025 is $452. These fees support ongoing regulatory oversight, ensuring that devices meet safety and compliance standards.
Drugs (Drug Identification Number Registration)
For drugs for human use requiring a Drug Identification Number (DIN), Health Canada has detailed fees based on the type of submission:
- New Active Substance: $606,286
- Clinical and Non-Clinical Data with Chemistry: $313,944
- Comparative Studies Only: $70,750
- Administrative Submissions: $1,002
- Labelling only: $6,328
- Disinfectant – Full review: $13,186
- Drug identification number application – Labelling standards: $1,912
These fees cover the rigorous evaluation process, ensuring products meet Health Canada’s stringent standards.
Additionally, companies engaged in various activities must hold a Drug Establishment License (DEL) which requires annual renewal. Fees are determined by the scope of activities and the types of products handled. The DEL fees for 2025 are:
- Fabrication – Sterile dosage form: $49,558
- Importation: $38,265
- Fabrication – Non-sterile dosage form: $36,740
- Distribution: $19,531
- Wholesaling: $11,398
- Packaging/labelling: $7,164
- Testing: $5,913
- Building outside Canada (each): $1,088
DEL fees ensure that establishments meet Good Manufacturing Practices (GMP) standards, supporting the safety and quality of pharmaceutical products in Canada.
For drugs already holding a Drug Identification Number (DIN), companies are required to pay an annual “Right to Sell” fee. The fee are as follows:
- Human drugs – Disinfectant: $1,730
- Human drugs – Non-prescription: $3,334
- Human drugs – Prescription: $5,531
These fees enable ongoing compliance monitoring and market authorization renewal.
Cannabis
For businesses operating in Canada’s cannabis industry, Health Canada Fees cover several areas, including application screening, security clearance, and regulatory oversight. As of now, Health Canada has not published updated cannabis-related fees for the fiscal year 2025-2026. The most recent fee adjustments, effective April 1, 2024, are as follows:
- Application Screening Fee: $3,933 for a standard-level license or sale for medical purposes and $1,969 for a micro-level license.
- Security Clearance Fee: $1,987 per individual requiring clearance.
- Annual Regulatory Fee:
- Micro Cultivator: If the cannabis revenue is $1 million or less, the greater of 1% of the cannabis revenue, and $2,500 OR if the cannabis revenue is greater than $1 million, the maximum amount plus 2.3% of the amount by which the cannabis revenue exceeds $1 million.
- Standard Cultivator: The greater of 2.3% of gross revenue or a minimum of $23,000.
Navigating these fees is critical for maintaining compliance and ensuring uninterrupted operations.
Why It Matters
Missing deadlines or miscalculating Health Canada fees can lead to costly delays or penalties. By planning ahead and leveraging expert guidance, you can focus on what matters most: growing your business.
Regulatory compliance doesn’t have to be daunting. At Quality Smart Solutions, we provide expert guidance to help you stay informed and save money. Explore more about our services to see how we can support your regulatory journey.
For a complete overview of all fees, visit Health Canada’s Funding and Fees page$1,002$36,740$3,334
