Whole Of Government Supervision Of Medical Devices

Health security problems and human medical device is closely related, and thesecurity of medical devices need to rely on the strict supervision and careful.Supervision of medical equipment is an important problem concerning the aspects,which must be the regulation in the existing regulatory framework of commonnessand individuality of a plurality of links are concerned. Therefore, this study from thetheoretical foundation to proceed, gradually development process of medical deviceregulatory and status were studied, based on analysis of the commonness andindividuality in the status of the problem, and then puts forward the countermeasurescorresponding to its design, improve the existing supervision of all sectors continuedto improve.The basic concept and principle of this thesis of the research related to thedescribed, puts forward the definition, classification of medical devices and supportthe implementation of supervision behavior theory, including government supervision,social control theory, public choice theory and other related theory; second,development history and current situation of medical device supervision in China thereview and analysis, puts forward the macro level of current medical deviceregulatory process problems and specific management problems. Among them, themacro problems include: the imperfect laws and regulations, regulatory agencies andpersonnel quality does not meet the requirements, supervision technology platform,the lack of supervision of weak performance evaluation, the supervision method doesnot meet the requirements, and at the micro level, the problem is mainly reflected inthe various links of the. Finally discusses the specific countermeasures, which include:continue to improve the reform of laws and regulations, the supervision organizationand related training, supervision of staff to develop good technology platform,implement the supervision data sharing, the design of performance evaluation systemto improve the supervision of supervision, supervision mode innovation performanceevaluation. And puts forward some workable concrete measures.