Medical Device Regulatory Problems In And Countermeasures

Medical Devices is related to people’s health, and even the lives of special commodity, it is widely used in disease prevention, many aspects of diagnosis, treatment,monitoring, mitigation, compensation, etc., have become an important part of health services. With the development of science and technology, new technology is widely used in many fields in the medical field, adverse events by the medical device product quality problems caused by increased year by year, to medical device regulation has brought new challenges. Faced with problems and challenges, government regulators must continually changing regulatory philosophy, innovative forms of regulation, improve the regulatory measures, and comprehensively improve the level of supervision.In this paper, we review the development of medical device supervision, research and analyze the development status and supervision system of medical devices industry in China and Xiangtan, summarize the status quo and characteristics of European and American medical devices, and compare the differences between them. Using the relevant theory of public management, and actively explore new mode of medical device supervision, combined with the actual situation of the development of medical devices industry in Jilin province and the actual situation of the supervision work, proposed that can promote the continuous and healthy development of the medical device industry, and can guarantee the product quality and safety supervision measures.There are six full part. The first part is an introduction, mainly on paper background,purpose and significance, the regulatory status quo at home and abroad, research ideas and the main content and research methods and innovations necessary instructions. The second part describes the theoretical analysis of this study, including medical device regulatory meaning, the role of medical supervision and theoretical basis for regulation of medical devices, such as government responsibility theory, market failure and government failure theory. The third part of the medical device regulatory problems exist- in Xiangtan City. A comprehensive analysis of the medical supervision of history, a careful analysis of the current situation in Xiangtan City, the medical device industry, presented in Xiangtan City Medical Device Regulatory problems and made clear that the causes of these problems.Part IV medical supervision at home and abroad learn from experience, including: the domestic medical device regulatory advanced mode and international medical device regulatory advanced mode. The fifth part corresponding countermeasures countermeasureon medical supervision, including improved regulatory treatment, strengthen professional training, to build a professional team, a set of policies, changes in the regulatory model,increase capital investment, improve infrastructure, strengthen technical support and enhance information technology, and the era of convergence. Part VI of the analysis based on the reality and make relevant conclusions.