Fees
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.
Most Therapeutic Products Directorate (TPD) 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.
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.
Financial Report
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