医疗器械监管中的问题及对策_毕业论文.docVIP

上海理工大学 成人高等学历教育 毕业设计(论文) 医疗器械监管中的问题及对策 医疗器械监管中的问题及对策 摘 要 随着财富的增长和人们对生命健康要求的提高，在最近几十年里，医疗器械产业发展越来越快，同时 关键词： 监管，问题，对策 PROBLEMS AND COUNTERMEASURES OF MEDICAL DEVICE REGULATION ABSTRACT As the growth of the wealth and the improvement of people to life and health requirement, in recent decades, medical apparatus and instruments industry development faster and faster, as well as drugs, medical devices at the same time be about human health and life safety of special goods, used in the diagnosis, prevention and treatment of human diseases, monitoring and mitigation and compensation, discipline, technical fields, wide, at work at the same time, there is the potential risk of adverse events in, therefore, need a professional, systematic, operational stronger laws and regulations to ensure its security, effectiveness. On April 1, 2000, with the implementation of the regulations on the supervision and administration of medical devices, medical device regulatory gradually took to the legal system in our country. Then, the state food and drug administration issued 15 administrative rules, basic formed the medical equipment management legal system with Chinese characteristics. But with the development of medical equipment industry and constantly improve the people health care demand, regulations on the supervision and administration of medical device law, low level, is not comprehensive, executable some problems appeared gradually. Such as the definition of medical apparatus and instruments is not comprehensive, classification is not scientific, low product registration is not unified. Key Words：Regulation, roblems, Countermeasures　 目　　录 第1章 绪 论 1 1.1 医疗器械监管法律的本质和医疗器械的定义 1 1.2 目前医疗器械主要监管部门和监管现状 1 第2章 医疗器械生产环节的监管 3 2.1 医疗器械生产环节 3 2.2 生产环节监管存在的问题 3 2.3 解决的对策 3 第3章 医疗器械经营环节的监管 5 3.1 医疗器械经营环节 5 3.2 经营环节监管存在的问题 5 3.3 问题产生的原因 6 3.4 解决的对策 7 第4章 医疗器械使用环节的监管 9 4.1 医疗器械经营环节 9 4.2 使用环节监管存在的问题 9 4.3 问