Fees for medical devices

Information for the medical device industry about fees related to devices, with links to supporting guidance and forms.

On this page

• Medical devices licence fees
• Medical devices establishment licence fees
• Fees for the right to sell medical devices
• How fees are set and how to pay them

Medical devices licence fees

The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications.

• Medical Device Licence Application Review Fees
• Guidance Document: Fees for the Review of Medical Device License Applications
• Guidance Document: Management of Application for Medical Device Licenses
• Medical Device Application Fee Form

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

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.

• Medical Device Establishment Licensing Fees
• Fees for the Review of Medical Device Establishment Licence Applications
• Guidance on Medical Device Establishment Licensing (GUI-0016)
• Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292)

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.

• Right to Sell Licensed Class II, III or IV Medical Devices Fees
• Guidance Document: Medical Device License Renewal and Fees for the right to sell Licensed Medical Devices

How fees are set and how to pay them

Fees for regulatory activities related to human drugs (pharmaceutical and biological) are charged based on:

• Fees in Respect of Drugs and Medical Devices Order

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

• Guidance Documents: Medical Devices
• Medical Device Applications Forms
• Establishment Licences

For information about paying invoices, refer to How to pay fees.