Study On The Problem And Countermeasures Of Medical Device Manufacturing Industry Regulation

Medical device is the product closely related to people's live and health. In recent years, with the international medical device market is rapidly expanding, the requirement of medical device is growing rapidly all over the world. China has become the third-largest medical device market except US and Japan. However, a lot of issues have arisen with the rapid development of medical device industry, especially in medical manufacturing area. For example, a number of medical device manufacturing companies in many regions are small scale and lack of technological support; many companies haven' t established GMP quality system yet, and there are many shortages in management system; part of the company's products and service quality is unsatisfactory, and competitive pressure causes speculation and shoddy behavior. The medical device manufacturer is primarily responsible for the quality of medical device, so governments have attached great importance to supervision and management of medical device manufacturers, and continue to adopt laws and regulations to establish good manufacturing practices for medical device manufacturers to implement regulation.In this article, it is mainly discussed that the problems in rapid development medical device industry, the comparison between domestic and international regulation of the medical device industry, the preliminary research about domestic medical devise regulation. Based on the past two years theoretical research and long time practical experience, the author give some commendations about how to improve and regulate medical devices industry both from the path of promoting law system and the path of enhancing grass-roots inspection power. At the same time it provides a reference and advice for other areas of Shanghai in medical device industry regulation.