Present Situation And Countermeasure Research Of Taizhou Medical Devices Safety Supervision

The basic characteristics of medical devices are safe and effective.They related to the public health and life safety,are an important part of the national food and drug safety strategies.In recent years,with the rapid development of economic society and sustained breakthrough of technology,the social public demand for life safety and health is continuously increasing with the enrichment of medical diagnosis and treatment measures.Medical devices direct service to the health care system,are the most important basic of public healthcare.The dependence of public health on the safe and effective of medical devices quality is growing,such as early diagnosis,surgical instruments,intensive monitoring and routine nursing However,due to the weak foundation of medical devices related industries in our country,the relatively late start of safety supervision,the regulatory mechanism in the reform period which has not yet been straightened out,and coupled with the interdisciplinary complexity of medical devices itself,the regulatory means are single and original,and the regulatory basis is relatively weak.These result in majority of the clinical damage caused by medical devices,from the widely harm "Ogilvy&Mather" to the nationwide clinical disability and death,and the frequent medical devices security incidents.Medical device regulatory situation is still grim.In this paper,through analyzing the necessity of the government to strengthen the medical devices safety supervision efficiency,quoting public choice theory and government regulation theory,using the methods of literature research,investigation and comparative analysis,setting from the medical devices industry status and the history and present situation of safety regulation,combining with the actual situation of medical equipment safety supervision in Taizhou region,researches show that there are mainly the following problems and shortcomings of medical device safety supervision:lack of regulatory resources led to inefficient supervision,professional ability of grass-roots law enforcement personnel is not strong,lack of regulatory capacity led to declining credibility.Through the comparison of the advanced experience of Hainan and other provinces and cities,drawing on the relatively mature security regulatory model of United States,Japan and other developed countries,put forward solutions and methods to solve the problems,and ultimately to realize the optimization of the path design of medical devices safety regulation and improving the security level of medical devices quality.