Fees for Medical Devices

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Fees for regulatory activities related to medical devices are currently charged as per the Fees in Respect of Drugs and Medical Devices Regulations [2017-06-30] under the Financial Administration Act. As of April 1, 2020, fees for medical devices will be charged as per the Fees in Respect of Drugs and Medical Devices Order. Supporting guidance, forms and current fee links are listed below.

Please visit How to Pay Fees for information regarding payment of invoices.

Medical Devices Licence Fees

The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications. The following types of medical devices are exempt from medical device licensing and therefore no fees apply:

  • Class I medical devices
  • custom-made medical devices
  • medical devices for special access
  • medical devices for investigational testing involving human subjects

For filing before April 1, 2020

For filing on or after April 1, 2020

Medical Devices Establishment Licence Fees

A Medical Device Establishment Licence (MDEL) is issued for activities of importing or distributing (selling) medical devices for human use in Canada. MDELs are also required for manufacturers of Class I medical devices that do not sell solely through a licensed Canadian importer or distributor. Fees are charged for the initial MDEL, subsequent annual licences and the reinstatement of a MDEL. The fees are applied equally to foreign and domestic establishments. Some are exempt MDEL fees.

For filling before April 1, 2020

For filling on or after April 1, 2020

Fees for the Right to Sell Medical Devices

Health Canada monitors medical devices on the Canadian market through post-market surveillance and compliance and enforcement activities. There is an annual fee for the Right to Sell a Class II, III, IV Medical Device.

For filing before April 1, 2020

For filing on or after April 1, 2020

For all other medical devices guidance documents and forms for applications, please visit:

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