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

You can apply for or renew small business status through the Drug and Medical Device Small Business Application. 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:

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 the 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 hc.sbo-bpe.sc@canada.ca.

Footnote 1

Companies that have not yet completed their first fiscal year will submit an estimated / projected annual gross revenue and their current employee total

Return to footnote 1 referrer

Footnote 2

Companies that have not yet completed their first fiscal year will enter their current fiscal year end date.

Return to footnote 2 referrer

Footnote 3

Unique identifiers are not required for affiliated companies

Return to footnote 3 referrer

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: