Small business mitigation for drugs and medical devices: How to apply for or renew small business status

You must have a valid small business status before you can obtain a fee reduction for drugs and medical devices submissions / applications / notifications.

On this page

• How to apply for or renew small business status
• Using the Drug and Medical Device Small Business Application

How to apply for or renew small business status

You can apply for or renew small business status through the Drug and Medical Device Small Business Application portal. You’ll receive an automatic status confirmation / rejection based on the small business definition.

Required information

When you submit a small business application we require you to give the:

• full legal company name
• unique identifier(s)
• business number (non-mandatory)
• annual gross revenue for your last completed fiscal year^{Footnote 1}
• number of full-time or equivalent employees for your last completed fiscal year^{Footnote 1}
• previous fiscal year end date^{Footnote 2}
• affiliate status
• breakdown of the above information for each affiliated company^{Footnote 3}
• contact information for all listed companies

Unique identifier

To learn about unique identifiers, including where they may be located and how you can receive one if you do not have one or cannot find it, please revisit our Small business mitigation for drugs and medical devices: Before you apply for small business status page.

Business number

A business number is a unique 9-digit number used by the Government of Canada as a standard identifier for businesses. Business numbers are required for Canadian companies to incorporate federally or to use a Canada Revenue Agency (CRA) program account.

Health Canada does not require a business number from international companies.

Using the Drug and Medical Device Small Business Application

Please follow these steps; to apply for small business status:

1. Log in to your secure web portal account
   (To obtain a secure web portal account, please refer to the instructions on our ‘Small business mitigation for drugs and medical devices: Before you apply for small business status’ page.)
2. Provide your activation code (if you are renewing skip step 2 and proceed to step 3)
   By providing your activation code, your account will be linked with your company’s information and you will gain access to the Drug and Medical Device Small Business Application. (Instructions for obtaining your activation code from Health Canada can be found on our ‘Small business mitigation for drugs and medical devices: Before you apply for small business status’ page.)
3. Select your unique identifier
   You must select the unique identifier of the product line you are applying for small business status for. At this time, you’ll only be able to select 1 entry at a time and will only receive a small business fee reduction for that selected unique identifier.
4. Input complete and accurate information for your company (and affiliates where applicable)
5. Certify that the information is accurate and complete
6. Submit your application
   Based on your information, the Drug and Medical Device Small Business Application will grant or not grant your application for small business status. Please note that when using the Drug and Medical Device Small Business Application you will not be able to save your application if you are unable to complete it in 1 session.

After receiving your small business status, you can apply for small business status for any remaining unique identifiers.

More information

If you have questions about our drugs and medical devices small business fee reduction measures, you can reach us at the Small Business Office at sbo-bpe@hc-sc.gc.ca.