Analysis And Research On Current Situation Of Medical Device Supervision

Medical Devices, as a product of modern science and technology, has been widely used in disease prevention, diagnosis, treatment, care and rehabilitation process. Medical devices has, as an important modern medical means, plays more and more important roles in the diagnosis and treatment of disease. But because of the increased biological contamination, biological incompatibility, and other potentially harmful electromagnetic pollution, the safety and effectiveness of medical devices has become the focus of the whole societyIn recent years, with the introduction and implementation of " Supervision and Regulation of Medical Devices ", the level of supervision and management of medical equipment in China is increasingly improved. The security situation is stable for the better. But compared with the world’s advanced countries, the management environment is not so much harmony so that some event has occurred due to poor medical equipment, because a complete regulatory inter-departmental coordination system has not set up, and there is a still gap to realize the standardized management of medical devices. The Food and Drug Administration in Dalian city and county level, as a medical device regulatory authorities, not only carrying out the supervision of medical devices, but also continue to accumulate experience in law enforcement at the same time, has profound understanding that the current supervision system can not fully guarantee the safety of the public use of medical devices. Therefore, it is necessary to carry out a systematic research on China’s medical device regulatory work, especially on grassroots supervision work.In this paper, based on the tools in Public Management and Administration Management Theory, author mainly use the methods such as literature research, inductive study, comparative analysis etc, take a researching and comparing analysis of the current literature of medical device regulatory system between China and abroad, combine with the Medical device regulatory practice in Dalian City, develop the current study on medical device regulatory work at present.This paper is divided into four chapters. The first part is an introduction. The second part is the comparison of domestic and international regulatory work on medical devices. The similarities and differences of six areas including the regulatory framework, definitions, legislation, registration, after the listing regulation, third party are Introduced among the United States, the European Union and China. The third part is to find out the deep-seated and fundamental causes combining the Dalian supervision data. The fourth part is to make analysis on problems proposed in the third part including the imperfect of medical device regulatory legal system, lack of technical support, weak of technical regulatory personnel and lack of supervision, to proposed measures and suggestions on how to build a new regulatory mechanisms of sound medical devices, construct the supervision team and inspection institutions, strengthen the after-listing supervision and information regulation, enhance the effectiveness of medical device regulatory.