Open
Small business mitigation for drugs and medical devices
Reduced fees for small businesses on health product reviews
Last Update: June 1, 2026
Funding available
Up to 50% of project cost
Timeline
- Open continuously
Location
Canada
Overview
This Health Canada program helps small businesses reduce fees associated with drugs and medical devices regulatory submissions and licences. Qualifying small businesses with fewer than 100 employees or annual revenues between $30,000 and $5 million CAD receive a free first pre-market evaluation submission, 50% off evaluation fees, and 25% off right to sell and establishment licence fees.
/100
Opportunity Score
Moderate potential, but conditions must align.
At a glance
Funding available
Financing goals
- No objectives are currently available
Eligible Funding
- Up to 50% of project cost
Timeline
- Open continuously
Eligible candidates
Eligible Industries
- Manufacturing
Location
- Canada
Legal structures
- For-profit business
Annual revenue
- From $ 30,000 to $ 5,000,000 in revenue
Organisation size
- 99 employees maximum
Audience
- All groups
Next Steps
1
Determine your project
2
Validate your eligibility
Activities funded
Pre-market Evaluation submissions for human drugs, Pre-market Evaluation submissions for veterinary drugs, Pre-market Evaluation submissions for medical devices, Right to Sell fees for drugs and medical devices, Establishment Licence fees for drugs and medical devices
Documents Needed
- Small business application details
- Fee forms, application forms, or RT templates
- Information on employees and annual gross revenue
- Affiliate company information, if applicable
Eligibility
Who is eligible?
- Pharmaceutical companies (human drugs)
- Veterinary drug companies
- Medical device companies
Eligible expenses
- Pre-market Evaluation fees for human and veterinary drugs.
- Pre-market Evaluation fees for medical devices.
- Right to Sell fees.
- Establishment Licence fees.
Ineligible Costs and Activities
- Applications submitted before small business status is obtained
- Businesses that do not meet the small business definition
- Companies with invalid or expired small business status at filing
Eligible geographic areas
- Companies based in Canada (all provinces and territories).
- International companies (businesses located outside Canada).
Processing and Agreement
- Applications are confirmed or rejected immediately after submission through the Small Business Application portal.
- You can print the application results and receive an email copy of the outcome.
- For fee reductions, small business status must be valid when the submission is filed.
- If requested, additional information may be required to verify small business status.
Additional information
- Fee reductions apply to human drugs, veterinary drugs, and medical devices.
- You must obtain small business status before submitting your application; otherwise, you will be invoiced the full fee.
- You must indicate your small business status on each fee form, application form, or regulatory transaction template.
- Veterinary drug pre-market evaluation submissions include Emergency Drug Release applications, Experimental Studies Certificate applications, Veterinary Health Product notifications, and Protocol Reviews.
Contacts
Frequently Asked Questions about the Small business mitigation for drugs and medical devices Program
Here are answers to the most common questions about the Small business mitigation for drugs and medical devices. This section explains what the program is, how much funding is available, eligibility requirements, application deadlines, and other important details to help you determine if this grant is right for your business.
What is the Small business mitigation for drugs and medical devices?
This Health Canada program helps small businesses reduce fees associated with drugs and medical devices regulatory submissions and licences. Qualifying small businesses with fewer than 100 employees or annual revenues between $30,000 and $5 million CAD receive a free first pre-market evaluation submission, 50% off evaluation fees, and 25% off right to sell and establishment licence fees.
How much funding can be received?
Small business mitigation for drugs and medical devices Funds up to 50% of admissible expenses.
Who is eligible for the Small business mitigation for drugs and medical devices program?
To be eligible for the Small business mitigation for drugs and medical devices program, you must:
The business must have fewer than 100 employees OR annual gross revenues between $30,000 and $5 million CAD.
The business must apply for and receive small business status before submitting any drug or medical device application.
Both domestic and international companies are eligible.
What expenses are eligible under Small business mitigation for drugs and medical devices?
Pre-market Evaluation submissions for human drugs, Pre-market Evaluation submissions for veterinary drugs, Pre-market Evaluation submissions for medical devices, Right to Sell fees for drugs and medical devices, Establishment Licence fees for drugs and medical devices
Who can I contact for more information about the Small business mitigation for drugs and medical devices?
You can contact Health Canada by email at sbo-bpe@hc-sc.gc.ca.
Where is the Small business mitigation for drugs and medical devices available?
The Small business mitigation for drugs and medical devices program is available across Canada.
Is the Small business mitigation for drugs and medical devices a grant, loan, or tax credit?
Small business mitigation for drugs and medical devices is a Grant and Funding