Quality System Requirements. Health Canada requires manufacturers of Class II, III and IV device to demonstrate that their devices are manufactured in accordance with internationally recognized standards. Demonstration of compliance with the quality system requirements will be required at the time an application is made for a medical device license.
Appears in 4 contracts
Sources: Distribution Agreement (Bovie Medical Corp), Termination, Purchase and License Agreement (Bovie Medical Corp), Termination, Purchase and License Agreement (Bovie Medical Corp)