GLOSSARYCA
Licensing (CA)
Canada requires an establishment license to import or sell a medical device, with exceptions for retailers, health care facilities, and certain manufacturers. No one may import or sell a Class II, III, or IV device unless its manufacturer holds a medical device license for it.
The two licenses
- Establishment license
- Held by a person who imports or sells a medical device. A retailer, a health care facility, and the manufacturer of a Class II, III, or IV device do not need one for that device (section 44).
- Medical device license
- Held by the manufacturer for each Class II, III, or IV device, and amended when the device changes in a way described in section 34. The manufacturer submits the application (sections 26 and 32).