Open
Small business mitigation for drugs and medical devices
Reduced fees for small businesses on health product reviews
Last Update: March 17, 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 status application form
- Fee forms or application forms
- Regulatory transaction (RT) templates
- Documentation confirming small business status
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
- Businesses that fail to obtain small business status before submitting their application or notification
- Companies that withdrew after receiving a Screening Deficiency Notice or after a Screening Acceptance Letter was issued
- Human drug companies seeking a free Veterinary drug pre-market evaluation (only the first human OR first veterinary submission is free, not both)
- Companies that previously withdrew or were rejected after a final review decision for Administrative or Labelling Standard submissions
- Businesses that do not meet the small business definition (100+ employees or outside $30,000–$5 million annual revenue range)
Eligible geographic areas
- Companies based in Canada (all provinces and territories).
- International companies (businesses located outside Canada).
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 (ETF) 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