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January 5, 2026
Approximately 5 minutes
Medical Device Licence Renewal Fees and Right to Sell – Health Canada Guidance
Medical Device Licence Renewal Fees and Right to Sell – Health Canada Guidance
Purpose and Legal Basis
This guidance document clarifies the annual fee requirements for renewing medical device licences under the Medical Devices Regulations (MDR) and the Fees in Respect of Drugs and Medical Devices Regulations. Maintaining a valid licence is mandatory to continue selling Class II, III, or IV medical devices in Canada. Failure to pay the renewal fee by the due date results in licence cancellation and loss of the right to sell the device. Guidance Document: Medical Device Licence Renewal Fees and Right to Sell Licensed Devices - Canada.ca
Who Must Pay Renewal Fees
- Holders of active medical device licences for Class II, III, and IV devices.
- Fees are charged annually to maintain the licence in good standing.
- Class I devices are exempt from licensing and renewal fees.
Fee Amounts and Structure
Annual renewal fees are fixed and vary by device class (as of the latest fee schedule):
- Class II: Lower fee (typically several hundred dollars).
- Class III: Higher fee.
- Class IV: Highest fee.
Fees are adjusted periodically based on the Consumer Price Index (CPI) and published on the Health Canada website. Multi-device licences may incur fees per device or per licence depending on the structure.
Payment Deadlines and Process
- Renewal fees are due on the anniversary date of the original licence issuance.
- Health Canada issues an invoice approximately 60 days before the due date.
- Payment must be received by the due date to avoid cancellation.
- Accepted payment methods include electronic funds transfer, cheque, or credit card (via specified channels).
- No grace period exists; late payment leads to automatic cancellation.
Exemptions and Reductions
- New licences issued within 90 days of the anniversary date may have the first renewal fee waived or prorated.
- Devices under special access or investigational testing may have fee exemptions in certain cases.
- Small businesses may qualify for fee reductions under the Small Business Fee Remission Policy (subject to eligibility criteria).
Consequences of Non-Payment
- Failure to pay the renewal fee by the due date results in immediate cancellation of the licence.
- Cancelled licences prohibit any sale, distribution, or advertising of the device in Canada.
- Manufacturers must notify Health Canada of intent to discontinue sales and manage inventory run-down.
- Reinstatement requires a new licence application and payment of applicable fees.
Practical Considerations
- Maintain accurate contact information to receive renewal invoices.
- Set calendar reminders for anniversary dates.
- Verify current fee amounts on the official Health Canada fees page.
- For multi-device licences, track individual device renewal status.
- Consult Health Canada’s fee inquiry service for clarification on specific cases.
This guidance helps licence holders meet their financial obligations to preserve market access for licensed medical devices. Detailed fee tables, payment instructions, exemption criteria, and examples of renewal scenarios are provided in the official Health Canada medical device licence renewal fees guidance document. Guidance Document: Medical Device Licence Renewal Fees and Right to Sell Licensed Devices - Canada.ca
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