Application Information
In Canada, manufacturers must receive a medical device licence for certain
health products defined as a "device" under the Food and Drugs Act before
they can be sold on the Canadian market. To determine which devices need
a licence, all medical devices have been categorized based on the risks
associated with their use. Prior to selling a device in Canada, manufacturers
of Class II, III and IV devices must obtain a medical device licence.
Although Class I devices do not require a licence, manufacturers, distributors
and importers are required to obtain an establishment licence.
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