a medical device that is set out in the list of medical devices for exceptional importation and sale or a medical device that is part of a category of medical devices that is set out in that list
Distributor:
a person, other than a manufacturer, an importer or a retailer, who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices in Canada is also considered a distributor.
Importer:
a person in Canada, other than the manufacturer of a device, who is responsible for the medical device being brought into Canada for sale
List of medical devices for exceptional importation and sale:
a person who sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf
Medical device:
a device within the meaning of the Medical Devices Regulations but does not include any device that is intended for use in relation to animals
Name of the device:
includes any information necessary for the user to identify the device and to distinguish it from similar devices
Regulations:
refers to the Medical Devices Regulations made under the Food and Drugs Act
