Research On Medical Appliance Supervision And Managing System In China

In the near decades, especially after open reform, with the continually increasing of social fortune and people’s life and health demands, our country’s medical appliance industry develops from small to big. As medical appliance is a special commodity for medical treatment even rescues the lives, its quality guarantee is more important than other commodities because of potential health and safe risk. Every country draws the relevant policy and supervision methods and systems in their medical appliance industry. Moreover, before or after medical appliance application sanction in public health, they must be appraised in quality, efficacy, reliability and security from different ranges.China starts supervision management in medical appliances commodities from 80s last century, mainly depends on sanitation administration and quality (technique) supervision authority. After 90s last century, our country participate in Global Harmonization Task. Force step by step. But it really starts uniform and complete legally supervise medical appliance enterprises and commodities from first-run reform of physic (medical appliance) supervision management system in 1998 and corning on "Stipulation on Medical Appliance Supervision Management ". Since our short history of medical appliance supervision management, our system set up borrowing more from successful experience of Western developed countries combining our situation of present medical appliance development. However, after several years’ practice, it appears process weakness and supervision vacancy. Moreover, people expect superior quality, efficacy, reliability and security in medical appliance supervision management. Under those background, it is an important research and practice issue of China medical appliance supervision system research.The thesis, from angle of our country development of medical appliance supervision system, on the basis of analyzing and comparison of other countries’ medical appliance supervision system, penetrate into discuss the existing problem in our present medical appliance supervision system, using public commodity theory, information asymmetry theory and father theory method, through analyzing the case of medical appliance supervision system in Wuxi, discuss the developing direction of our country medical appliance supervision system, and put forward the practical, efficient measure to supervise medical appliance borrowing from foreign successful experience. The whole thesis, using the methods of literature data, historical research, comparison research, theory analysis, and case analysis, profoundly and systematically analyzing the present situation and existing problems of our country medical appliance, definitely put forward reform target and measures, in order to provide the theory base and feasible operation pathway for efficient medical appliance supervision.