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Annual Charges

Device Licence annual fees​

Manufacturers holding one or more Device Licences pay an annual fee for each licence. Health Canada invoices licence holders annually.

Key points:

  • Annual fees apply to all active Device Licences
  • Fees are set by the Medical Devices Regulations Fees Order
  • Small businesses may be eligible for reduced fees

MDEL annual fees​

MDEL holders pay a separate annual fee for their establishment licence. The MDEL fee covers all activities listed on the licence.

Payment and consequences​

Annual fees must be paid within the period specified on the invoice. Non-payment can result in:

  • Reminder notices from Health Canada
  • MDEL or Device Licence suspension if fees remain unpaid after a defined period
  • Legal consequences under the Financial Administration Act

Fee management best practice​

  • Set reminders for annual fee due dates
  • Maintain current billing contact information in HRES
  • Cancel licences for products no longer sold in Canada to avoid unnecessary fees
  • Apply for small business fee reductions when eligible

Current fee schedule​

The current annual fee amounts are published on the Health Canada website and in the applicable Fees Orders. Fees are subject to periodic revision (including inflation-based adjustments).

Official resource: Health Canada — Medical Device Fees