To complete the Health Canada medical device licence application fee form, download the fillable PDF from Health Canada, enter your device and manufacturer details, select the fee that matches your device class and application type, note any remission or small business status you qualify for, and submit the form as part of your licence application package through the Common Electronic Submissions Gateway. No licence application enters review until Health Canada has a properly completed fee form with the correct amount, so this document controls how fast everything else moves.
Where to Download the Form
The fee form is a fillable PDF on Health Canada’s medical device application forms page.1Government of Canada. Medical Device Application and Report Forms The same page holds the licence application itself, which the fee form must accompany. Before filling anything out, confirm your device’s classification (Class II, III, or IV) and the exact type of application you’re filing. The fee depends entirely on those two facts.
What Goes on the Form
The form has sections for device identification, manufacturer details, the applicable fee, and payment authorization.
Device and Manufacturer Details
Enter the device name exactly as it appears on the device label. If you’re filing an amendment, include the licence number being amended. The manufacturer section asks for contact name and title, company name, mailing address, email, and phone numbers for both domestic and international lines. The Company ID field is optional if Health Canada has not yet assigned you one.2Government of Canada. Medical Device Licence Application Fee Form
Selecting the Right Fee
The form lists every fee category so you can find the correct line item and enter the amount. Fees are set by the Fees in Respect of Drugs and Medical Devices Order and adjusted annually.3Justice Laws Website. Fees in Respect of Drugs and Medical Devices Order As of April 1, 2026, the standard new-licence application fees are:4Government of Canada. Fees for Health Canada
- Class II new licence: $643 CAD
- Class III new licence: $14,163 CAD
- Class IV new licence: $30,713 CAD
Amendment fees and fees for specialized categories (near-patient in vitro diagnostic devices, private label devices, and changes related or unrelated to manufacturing) are different. A private label licence application for any class is $147 CAD.3Justice Laws Website. Fees in Respect of Drugs and Medical Devices Order Match your situation to the exact sub-category on the form. Entering the wrong amount is one of the fastest ways to draw an administrative deficiency notice and lose your place in the queue.
Reducing or Deferring the Fee
Three separate mechanisms can cut or delay what you owe. They are not interchangeable, and you have to identify the right one before you file.
Fee Remission for Low-Revenue Devices
The form has a dedicated fee remission section for manufacturers whose anticipated gross revenue from the device is $100,000 CAD or less. To claim it, include a signed statement from the person responsible for your company’s financial affairs certifying that the application fee exceeds 2.5 percent of the anticipated gross revenue. Attach a marketing plan, sales history, estimated market share, and average sale price information.2Government of Canada. Medical Device Licence Application Fee Form This remission is separate from the small business program below.
Small Business Fee Reduction
A qualifying small business gets a 50 percent reduction on pre-market evaluation fees (the licence application review fee) and a 25 percent reduction on right-to-sell and establishment licence fees. If you are filing your first-ever pre-market submission of any kind with Health Canada, the fee is waived entirely.5Government of Canada. Funding and Fees – Drugs and Health Products
To qualify, your business including all affiliates worldwide must have either fewer than 100 employees or annual gross revenue between $30,000 and $5 million CAD. You must receive small business status before submitting your licence application. Submit without it and Health Canada invoices you the full fee.6Government of Canada. Small Business Mitigation for Drugs and Medical Devices
Apply through the Drug and Medical Device Small Business Application portal, where you enter your legal name, unique identifier, employee count, gross revenue, fiscal year end date, and affiliate information.7Government of Canada. How to Apply for or Renew Small Business Status Companies that have not yet completed a first fiscal year can submit projected figures. Once you hold small business status, indicate it on your fee form and, if claiming the first-ever waiver, mark that box too.
Deferred Payment for Brand-New Companies
If your company has not yet completed its first fiscal year on the day you submit the application, you qualify for a one-year payment deferral. Include a signed statement from your financial officer specifying when your fiscal year began.2Government of Canada. Medical Device Licence Application Fee Form
How to Submit the Form
Medical device licence applications, fee form included, are transmitted through the Common Electronic Submissions Gateway (CESG).8Government of Canada. Guidance on the Regulatory Enrolment Process for Medical Devices – Transmission via CESG You need to register as a trading partner with Health Canada before you can use it. Include the completed fee form as a standalone PDF within your submission so administrative staff can route it straight to financial processing.
Follow the folder structure and file naming conventions Health Canada expects. Screening staff verify these alongside the fee form itself, and incorrect structures or names can draw a deficiency notice.9Government of Canada. Guidance on Managing Applications for Medical Device Licences – Screening Process
How to Pay
Payment timing depends on the amount. For fees of $5,000 CAD or less, which covers all standard Class II applications, submit payment together with your application. For fees above $5,000, don’t send payment with the application. Health Canada invoices you after receiving the submission.2Government of Canada. Medical Device Licence Application Fee Form
Accepted payment methods are credit card, direct deposit, wire transfer, cheque, bank draft, and money order. All payments must be in Canadian dollars; other currencies are rejected.10Government of Canada. How to Pay Health Canada Fees Payment through a Canadian financial institution’s bill payment service is also available.
If paying by cheque, bank draft, or money order, make it payable to the “Receiver General for Canada” and mail to:
Health Canada, Accounts Receivable
Address Locator: 1918B, 18th Floor, Room 1804B
Jeanne-Mance Building
161 Goldenrod Driveway, Tunney’s Pasture
Ottawa, Ontario K1A 0K910Government of Canada. How to Pay Health Canada Fees
For wire transfers, use the bank details on Health Canada’s payment page and include a copy of the transfer receipt with your application package so the payment can be matched to your file.
What Screening Checks For
Once Health Canada receives your application, it goes into administrative screening. Staff verify that the fee form is complete, the correct fee was entered, and the overall package is administratively sound. If something is missing, you receive a request for outstanding information and have 10 calendar days to respond. Miss that window, or answer incompletely, and the application is rejected. A rejection at the screening stage carries no fee, so you can fix the issues and resubmit without financial penalty.9Government of Canada. Guidance on Managing Applications for Medical Device Licences – Screening Process The financial side has to be settled before the substantive technical review proceeds.
What Happens If You Withdraw
What you owe on withdrawal depends on how far the application has moved and on device class.11Government of Canada. Guidance Document – Fees for the Review of Medical Device Licence Applications For Class III and IV applications, withdrawing before acceptance into review (with no screening deficiency letter issued) costs nothing. Withdrawing after a screening deficiency letter has been issued costs 10 percent of the applicable fee. Rejection during preliminary examination also costs 10 percent. Withdrawing after a screening acceptance letter has been issued costs the full fee, with no refund. For Class II applications, including amendments and private label applications, 100 percent of the fee applies once the application has been deemed administratively complete, regardless of withdrawal.
The Annual Right-to-Sell Fee
The application fee is not the end of it. Under Section 43 of the Medical Devices Regulations, manufacturers renew their licences annually and pay a right-to-sell fee to keep each licensed device on the Canadian market.12Justice Laws Website. Medical Devices Regulations As of April 1, 2026, the annual right-to-sell fee is $460 CAD per licensed Class II, III, or IV device.13Government of Canada. Fees for the Right to Sell Licensed or Authorized Class II, III or IV Medical Devices Small business status reduces this fee by 25 percent.5Government of Canada. Funding and Fees – Drugs and Health Products Missing the annual payment puts your licence at risk of cancellation, which sends you back to the beginning of the application process.