Understand The Regulatory And Demographic Environment Of The Medical Device Industry

In today’s market, understanding the regulatory and demographic environment of the medical device industry is the only part of the challenge. The real struggle of the medical device companies is to adapt the right strategy, creating the business plan and executes it efficiently. The companies that are taking advantage of this medical device business cycle become successful. The examples of medical device include pacemakers, artificial heart valves, diagnostic and imaging equipment, hip and knee implants, surgical tools, infusion pumps, life support machines catheters and communication technologies.

In Canada, medical devices are regulated under the Food and Drugs and Act as a Cass I, II, III and IV. Class I represents the lowest risk and class IV the highest risk. There is no license require for the class I medical device to sell in Canada compare to other three classes of medical devices. In Canada, medical devices are approved through Health Canada’s Therapeutic product Directorate, which applied the Food and Drug, and Medical Devices Regulations under the authority of the Food and Drug Act to product approval. The medical Device Bureau of the TPD maintains a database of all licensed class II, III and IV medical device offered for sale in Canada. Class I medical devices do not require a medical device

For example, MaRS is an NCE focused on health sector innovations mainly technology transfer commercialization of the researches in the universities. Further, Canada has a well-established based of supportive industry such as information technology, which will be a great benefit for the diagnostic and treatment products of medical device industry. For example, research in motion is a Canadian IT company which is having collaboration with several medical device