Research On The Problems And Countermeasures Of Medical Device Regulation In Jiangsu

As a special product,medical devices are closely related to public health and life safety.Medical devices bring people not only intended uses,but also some potential risks.In the recognition of the shocking hazards of problem medical devices,how to strengthen the regulation of medical devices has become the focus of the whole society.Combined with work practice,synthetically uses the public management theory,research approaches of literature,investigation and comparative analysis,this paper demonstrates the problems existing in the medical device regulation of Jiangsu Province,analyzes the causes and puts forward some countermeasures on the basis of foreign experiences.The preface of this paper introduces the research background and significance,relevant literature reviews,methods as well as innovations and shortcomings.The first chapter explains some related concepts and theoretical basis of medical device regulation,and analyzes the necessity of governments regulation of medical device.The second chapter introduces the current situation of China’s medical device industry and its supervision.The third chapter mainly sums up five problems of medical device regulation,they are incomplete regulations,various regulatory bodies,inadequate supervision,the lack of technical support and public supervision,then analyzes the causes of the problems.The forth chapter expounds the advanced experiences of developed countries in Europe and America and the enlightenments for China.On the basis of the above analysis,the final chapter puts forward the following countermeasures:improving the legal system,deepening the reform of the regulatory system,strengthening the main responsibility of enterprises and encouraging social resources to participate in the medical device regulation.