Investigation Of Management And Development Process Of Medical Device Standards

The thesis presents an investgation results on current medical device standards regulation and standards development process of U.S., Europe and China. Though consulting, tidying up and analyzing the medical device standards information of U.S., Europe and China , such as the regulatory and policy of medical device, the current medical device standards, the development process of medical device standards and the use of medical device standards, The thesis will point out the problems and deficiency of current medical device standards of China, and give the resolvents of the problems.The thesis is constitute of three parts. Part one is about the basic knowledges of standards. As medical device regulation mode is the basic of analysing medical device standards management, this part illuminate the classification and dynamic regulationg prosess of medical device from product risk/benefit and total life span., then analyzing the medical device regulation mode of U.S., Europe and China. The second chapter is about the classification of medical device standards, technical regulation, voluntary standards, international standards organization.The second part discourse upon the management current, problems and solutions of China's medical device standards on the basis of comparative analysis of the United States, the European Union and China in the medical device regulations, standards of medical equipment status, standard management mechanisms.China requires all medical device products before approving into the market to develop and meet the product standard. This result in the energy and money waste of as a control means on a low risk device and nonsufficient actuality as a control means on a high risk device. Therefore standards cannot play its proper role as a means of quality control in the supervisory process.And china putting too much emphasis on the standards for product quality control methods results in many many vertical standards and poor level standard that is suitable all products.In china regulatory authorities develop and revise standard of medical device and standard is a very important mean as control product quality. So this waste piss and vinegarof managenment department and make the management efficiency reduced.After all the above problems result from that Chinese current unprefect management mechanism of medical equipment standard. Improving it will be possible to resolve the various specific issues of the standard management.The third part of papers focus on the formulation of standard medical equipment and with participations of standard development during graduate students points out the issues on development authority, personnel, procedures, timing, technic requirementand and testing methods and puts forward proposal.