Cost recovery is a federal government policy intended to promote more business-like and equitable management of government programs. The policy stipulates that specific individuals or firms, who benefit directly from or cause government activity should bear some or all of the cost of those activities.

Many of Health Canada's regulatory activities represent a direct benefit to or are triggered by companies selling therapeutic products on the Canadian market; therefore, these activities are considered appropriate for cost recovery.

Cost Recovery

Establishment Licence Fees

Establishment licences are required for establishments that import or distribute any medical device. Licences are also required for manufacturers of Class I medical devices that do not sell through a licensed Canadian importer or distributor. Fees are charged for the initial licence, subsequent annual licences and the reinstatement of a licence. The fees are applied equally to foreign and domestic establishments. Some are exempt from establishment licence fees.

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

There is also an annual fee for the right to sell a Class II, III, IV medical device.

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