【作者】 王迪；

【导师】 傅静；

【作者基本信息】 山东大学 ， 公共管理（专业学位）， 2021， 硕士

【摘要】 近来,医疗器械行业飞速发展,医疗器械风险事故也时有发生。尤其2020年新型冠状病毒肺炎疫情突然来袭,各类医疗器械供不应求。在舆论的渲染和社会需求双重刺激下公众对医疗器械的关注度越来越高。医疗器械生产企业作为医疗器械产品源头,对其监管必须有更高的要求。本文通过对比国内外医疗器械生产企业监管现状,借鉴国外先进国家和地区的经验做法,采用案例研究法、访谈法。系统分析医疗器械生产企业监管存在的问题并提出合理化对策,以达到保证人民群众用械安全和促进医疗器械生产企业高质量发展的目的。论文写作的大体行文思路为:首先阅读医疗器械监管方面的国内外最新论述汲取前人经验;以滨州市医疗器械生产企业为案例进行摸底调研,选择与研究课题相关的关键人员进行一对一的访谈,分析和汇总数据,最后论文经过反复编辑修改形成定稿。通过对滨州市医疗器械生产企业的监管研究得出我国医疗器械生产企业监管方面还有很大的提升空间。一方面需要加强与世界沟通交流,可以借鉴美国、欧盟、日本等一些行业发展较为领先的国家的制度、体系、系统、理念等。另一方面我们需要结合实际多维度提升医疗器械生产企业监管水平,保证群众用械安全促进行业发展。本文的创新之处在于理论与实际的紧密结合。由于研究课题与作者工作息息相关实践经验较为丰富并结合管理学相关理论,运用案例法、访谈的方法以及通过对国外医疗器械生产监管的认真研究,试图找到一条既能保障人民群众用械安全又能促进医疗器械生产企业高质量快速发展的道路。更多还原

【Abstract】 Recently,the medical device industry has developed rapidly,and medical device risk accidents have also occurred from time to time.Especially in 2020,the new type of coronavirus pneumonia suddenly hits,and the supply of various medical devices exceeds demand.Under the dual stimulation of public opinion and social demand,the public is paying more and more attention to medical devices.As the source of medical device products,medical device manufacturers must have higher requirements for their supervision.This article compares the regulatory status of domestic and foreign medical device manufacturers,draws on the experience and practices of advanced foreign countries and regions,and adopts the method of case study and interview.Systematically analyze the problems in the supervision of medical device manufacturers and propose reasonable countermeasures to achieve the purpose of ensuring the safety of the people in the use of devices and promoting the high-quality development of medical device manufacturers.The general idea of writing the thesis is:first read the latest domestic and foreign expositions on medical device supervision to learn from previous experience;take Binzhou medical device manufacturers as a case to conduct a survey,and select key personnel related to the research topic for one-to-one Interview;analyze and summarize the data,and finally the paper is finalized after repeated editing and revision.Through the supervision research of medical device manufacturers in Binzhou City,it is concluded that there is still a lot of room for improvement in the supervision of medical device manufacturers in my country.On the one hand,we need to strengthen communication and exchanges with the world,and we can learn from the systems,systems,systems,and concepts of some countries that are more advanced in industry development such as the United States,the European Union,and Japan.On the other hand,we need to improve the supervision level of medical device manufacturers in multiple dimensions based on the actual situation,and ensure the safety of the masses to use the equipment to promote the development of the industry.The innovation of this article lies in the close integration of theory and practice.As the research topic is closely related to the author’s work,the practical experience is relatively rich,combined with management related theories,the use of case method,interview methods and careful research on the supervision of foreign medical device production,trying to find a way to ensure the safety of the people’s use of equipment Promote the path of high-quality and rapid development of medical device manufacturers.更多还原