Medical Device Regulatory Problems And Countermeasures Under The New Round Of Reform

A new round of institutional reform has been launched since 2013.Market supervision authority was founded whose responsibility included Administration of industry and commerce,Bureau of Quality and Technical Supervision,Food and drug administration.Medical device is an important support for medical services,which has a direct impact on public health and social stability.Wujin district of Changzhou is famous of its medical device industry.But there are still many problems about the production,operation and use of medical devices in Wujin.Moreover,after several years' practice,it appears process weakness and supervision vacancy.n recent years,people's living standards and quality of life are getting higher and higher,with the expectation of the quality,safety and management level of medical devices.People expect superior quality,efficacy,reliability and security in medical device supervision management.Under those backgrounds,it is an important research and practice issue of China medical device supervision system research.In order to further promote the healthy and orderly development of Wujin medical device market,not only give full play a decisive role in market allocation of resources,and better play the role of government regulation,in this article will focus on a new round of reform in the background,to sort out the supervision of medical device in Wujin.Wujin of regulatory agencies are medical device regulatory supervision mode the market under its own system,means of supervision team,and other issues,and medical device supervision object production management and use of the problems,and in-depth analysis of its causes.In the analysis,this paper uses the methods of literature,theoretical analysis,empirical analysis,history research,more research,comprehensive analysis of the status,basic medical device regulatory difficulties and causes of innovation,research methods and research content.Finally,according to these problems,the corresponding countermeasures and suggestions are put forward.The first two chapters are the introduction and the theoretical analysis of medical device and its supervision.The third chapter reviews the history of the regulation of medical devices,and expounds the present situation of reform.The fourth chapter,combined with the actual work,takes the Wujin District of Changzhou city as an example to explore the existing problems and the causes of the medical device supervision under the current system.Finally,forward countermeasures and suggestions were put in the fifth chapter.