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Fees & Charges

Overview​

Health Canada charges fees for Device Licence applications, Device Licence maintenance, and Medical Device Establishment Licences (MDELs). The fee schedule is established by regulation and is subject to periodic review.

Device Licence application fees​

Fees are charged for each Device Licence application submitted to Health Canada. The applicable fee is based on device class:

Device classFee category
Class IIStandard fee
Class IIIStandard fee (higher than Class II)
Class IVStandard fee (higher than Class III)

The current fee amounts are published on the Health Canada website and in the Medical Devices Regulations Fees Order.

Annual Device Licence fees​

Device Licence holders pay an annual fee to maintain each Device Licence in good standing. Annual fees are invoiced by Health Canada and must be paid to avoid licence suspension or cancellation.

Medical Device Establishment Licence (MDEL) fees​

MDEL holders pay an annual fee based on the activities covered by the MDEL (importing, distributing, manufacturing Class I).

Fee reductions for small businesses​

Health Canada provides fee reductions for small businesses that meet defined criteria:

  • Fewer than 50 full-time employees (globally), or
  • Annual gross revenue below a defined threshold (see current regulations)

Small businesses may be eligible for a significant reduction (typically 50–75%) in application and annual fees.

Fee waivers​

Fee waivers may be available for:

  • Devices intended solely for humanitarian use
  • Devices intended solely for export from Canada (not for sale in Canada)
  • Government departments and agencies

Refund policy​

Fees are generally non-refundable once a submission has been accepted for review. Partial refunds may be available if a submission is withdrawn before review begins.

How to pay​

Fees are invoiced electronically by Health Canada through the HRES portal. Payment must be made within the specified period or the application may be placed on hold.

Official resource: Health Canada — Fees for medical device submissions