Fees for Medical Devices
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. Supporting guidance, forms and current fee links are listed below.
- How to Pay Fees [2016-08-02]
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
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 Licensing Fees [2017-02-20]
- Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees [2017-02-29]
- Medical Device Establishment Licence Application: Form and Instructions (FRM-0292) [2013-06-28]
- Medical Device Establishment Licence: Calculation Chart [2017-02-20]
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.
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