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.
- How to Pay Fees [2011-02-18]
- Guidance Document on Cost Recovery - Fees in Respect of Medical Devices [2011-03-18]
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 Device Establishment Licence Application: Form and Instructions (FRM-0292) [2011-04-01]
- Medical Device Establishment Licence: Calculation Chart [Updated 2015-04-01]
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.
Guidance for Medical Device Licence Renewal
Cost Recovery Initiative
In April 2011, the Health Products and Foods Branch (HPFB) updated user fees for the human drugs and medical devices regulatory programs, as part of its Cost Recovery Initiative.
Building on and consistent with Health Canada policies and direction, the Cost Recovery Initiative's goal is to develop and implement a cost recovery framework to provide a long-term stable funding source for HPFB's regulatory activities.
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