Medical devices cover an array of medical or health instruments used to treat, mitigate, diagnose, or prevent a disease or abnormal health condition. These devices include pacemakers, hip implants, artificial heart valves, thermometers, syringes, contraceptive devices, and medical laboratory diagnostic instruments. 

In Canada, medical devices are classified into one to four classes. Class I doesn’t require any medical device license, while Class 2, 3, and 4 require a license. In USA, medical devices are classified into Class I, II, and III.  Most Class I devices are exempt from Premarket Notification 510(k) and most Class II devices need Premarket Notification 510(k); whereas Class III devices require Premarket Approval. All classes of medical devices in Canada and USA must be manufactured under Canadian medical device regulations and FDA regulations respectively.