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MDEL Fees & Charges

Annual MDEL fee​

MDEL holders pay an annual fee to maintain their establishment licence. The fee covers all activities listed on the MDEL (importing, distributing, manufacturing Class I).

Annual fees are invoiced by Health Canada. Non-payment can result in MDEL suspension.

Fee structure​

The annual MDEL fee is set by regulation. The current fee amounts are published on the Health Canada website.

Small business fee reduction​

Health Canada provides fee reductions for small businesses. A small business is eligible for a reduced MDEL fee if it meets the criteria defined in the applicable Fees Order:

  • Fewer than 50 full-time employees globally, or
  • Annual gross revenue below the threshold set in the Fees Order

Small businesses typically receive a 50% or greater reduction in annual MDEL fees.

Fee waivers​

Fee waivers may be available for:

  • Government departments and agencies
  • Not-for-profit organisations in specified circumstances

How fees are paid​

Fees are invoiced by Health Canada, typically annually. Payment is made through Health Canada's online payment system.

Consequences of non-payment​

Failure to pay annual MDEL fees within the required period may result in:

  • MDEL suspension
  • Loss of ability to legally import or distribute devices in Canada

Official resource: Health Canada — Fees for medical device submissions