Medical Devices Industry Profile
In Canada, medical devices are regulated under the Food and Drugs Act as a Class I, II, III or IV with Class I representing devices that present the lowest risk and Class IV the highest. The Food and Drugs Act provides a definition of a regulated medical device.
Examples of medical devices include pacemakers, artificial heart valves, diagnostic and imaging equipment, in vitro diagnostics, dialysis equipment, hip and knee implants, synthetic skin, surgical tools, infusion pumps, life support machines, catheters, bandages, as well as some information and communications technologies.
The complexity of medical device products continues to increase with the inclusion of multiple technologies into a given product. Technologies such as advanced materials, microelectronics, biotechnology, and software and informatics are now routine technologies featured in medical devices. Canadian and international companies continue to innovate further to develop new products and enhance the features of existing medical devices.
Firms in the medical device sector are highly R&D intensive and technology based.