The Research And Countermeasures Of Medical Device Regulation In China

In recent years, China’s medical device industry has developed rapidly, but many problems have come up with a higher requirement for the regulation of medical devices. The public management science and risk management theory as a guide, in our country gradually introduced background of a number of medical devices regulations and rules under, from the status quo of China’s medical equipment safety supervision of combined with years of medical device regulatory experience, but also with reference to the experience of foreign advanced countries and regions, the system analysis the medical device supervision of internal and external factors and the existing problems at present, and puts forward the countermeasures and suggestions.This thesis consists of six chapters, the first chapter introduces the research background and the domestic and foreign medical device regulatory research status, the second chapter introduces the theoretical basis of medical device regulation, the third chapter analyzed the status quo of China’s medical equipment safety supervision, the fourth chapter analyzes the existing problems, the fifth chapter introduced regulatory experience of developed countries in the world, the sixth chapter put forward the corresponding countermeasures and suggestions.The last chapter is the conclusion.The innovation of this paper is to 2014 version of the supervision and administration of medical devices regulations "and its supporting regulations, from the perspective of public management specification documents after the introduction of the medical device regulatory system for system analysis, also in accordance with the theory of risk management, put forward problems and risks existing in the current medical device regulatory system, such as information asymmetry, industry non perfect competition, inspectors professional quality to be improved, medical device testing institutions distribution is not balanced, supporting regulations and regulations are not perfect, enterprise’s main body consciousness is not strong,.At the same time, puts forward the corresponding countermeasures and suggestions, such as the integration of information resources, support enterprise innovation, sound inspector training and incentive policies, accelerate the construction of inspection ability, improve laws and regulations, give full play to the supervisory role of the third party etc..