Medical device companies must comply with the MDR to legally manufacture, import, and distribute the products in Canada
Manufacturers, importers or distributors that sell or import medical devices in Canada must have a license for facility or medical devices to sell certain devices depending on their type pursuant to MDR
- Manufacturers of class Ⅱ,Ⅲ,Ⅳ medical devices must have the medical device license (MDL) to manufacture medical devices
- Registration process vary depending on class of medical devices, and the amount of information to be submitted increases as the class increases
- There is a gap between the general medical device requirements and the in vitro diagnostic device submission, and manufacturers that desire to sell medical devices must complete and submit a specific application for the corresponding class
Type of licenses
- Device license: License to be obtained by a manufacturer
- Establishment license: License to be obtained by an importer or a distributor
For more information of medical devices with the device license, please see the following list of Medical Devices Active License (address below)