Study Of Medical Device Industry Regulation Status And Changes

Medical device, as a special commodity, concerned with people's health and safety, is an important part of regulation of food and drug stuff. The current global focus on medical device regulation turns from check before marketing to regulation after marketing, from quality control to regulation of production process.In recent years, our medical device industry continues to maintain rapid development, yet regulation faces more and more problems. Meanwhile changes in food and drug regulation system bring many new problems and challenges to regulation of medical devices. Regulation departments must constantly change their regulation notion and manner and improve their regulation measures to raise their regulation level. This paper systematically reviews the production of medical device and regulation process as well as our current legal system for medical device production regulation. Based on the working practice of the production regulation of medical device, Regulation of medical device manufacturing problems from the legal system, technical support system, regulatory enforcement system, the production company conducted in-depth analysis of four levels. Finally, the authors compared the production of medical devices in Europe and America learn from regulatory approach, experience, based on the proposed regulation from the well-developed legal system, improve the regulatory technical support system, strengthen the monitoring team building and innovative long-term regulatory mechanism of four-pronged approach to strengthen the medical source of regulatory instruments to promote the healthy development of medical devices and improve people's health condition.