安徽省第二类医疗器械生产企业在产品注册中存在的问题及对策研究

发布时间：2018-04-23 12:37

本文选题：医疗器械 + 注册　；参考：《山东大学》2014年硕士论文

【摘要】：近年来,随着社会的高速发展,科技创新的日新月异,人民大众对医疗保健的需求越来越高,医疗器械行业的发展无论是在大众的医疗安全中,还是在国民经济发展中都占据了越来越重要的位置。依照相关规定,在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理的单位和个人,都必须遵守《医疗器械监督管理条例》。依照《条例》,第二类医疗器械必需经注册方可批准生产、销售。产品的安全和有效来源于设计,设计阶段就注定了产品的有效性和安全性,本文从医疗器械产品的注册工作入手,从医疗器械产品的源头探讨医疗器械行业存在的问题及对策研究,安徽省食品药品审评认证中心承担着安徽省第二类医疗器械注册产品的技术审评工作,本文通过抽取样本对大量安徽省医疗器械产品注册资料的原始数据进行统计分析,采用描述性统计分析方法中的集中程度测定等方法,梳理出安徽省第二类医疗器械在产品注册中存在的问题,并逐一分门别类地对这些问题进行详细的具体分析。同时,通过与安徽省省市级监管部门、技术机构和医疗器械生产企业的相关人员的访谈调查,深入了解整个安徽省第二类医疗器械产品注册工作的现状,包括存在的问题和形成原因,并进行详细分析论证,最后尝试进一步有针对性地提出改进现状的对策和建议。因国内外相关专注于医疗器械产品注册的著作文献很少,笔者力图通过撰写本文来达到抛砖引玉的目的,指导生产企业如何提高产品注册通过的效率同时,希望通过社会各界的共同努力,将我省的医疗器械产品注册工作发展得更完善,更能适应未来医疗器械行业发展的需求。
[Abstract]:In recent years, with the rapid development of society and the rapid development of science and technology, the people's demand for medical care is higher and higher. The development of medical device industry is not only in the medical safety of the public, Still occupy more and more important position in national economy development. In accordance with relevant provisions, units and individuals engaged in the development, production, operation and use of medical devices within the territory of the people's Republic of China, as well as their supervision and administration, must abide by the regulations on Supervision and Administration of Medical Devices. According to the regulations, Class II medical devices must be registered before they can be approved for production and sale. The safety and effectiveness of the product comes from the design, and the design stage is doomed to the effectiveness and safety of the product. This paper starts with the registration of the medical device product. The problems and countermeasures in the medical device industry are discussed from the source of the medical device products. The Anhui Food and Drug Evaluation and Certification Center is responsible for the technical review of the second kind of medical device registration products in Anhui Province. In this paper, we take samples to analyze the raw data of a large number of medical device registration data in Anhui Province, and use the method of concentration measurement in descriptive statistical analysis method. The problems existing in the registration of the second kind of medical devices in Anhui Province are combed out, and these problems are analyzed in detail one by one. At the same time, through interviews with relevant personnel of provincial and municipal regulatory departments, technical institutions and medical device manufacturing enterprises in Anhui Province, we have a thorough understanding of the status quo of the registration of the second kind of medical devices in Anhui Province. Including the existing problems and causes, and detailed analysis and demonstration, and finally try to further improve the current situation of countermeasures and suggestions. Because there are few literature about medical device registration at home and abroad, the author tries to write this article to achieve the purpose of guiding production enterprises how to improve the efficiency of product registration at the same time, It is hoped that through the joint efforts of all walks of life, the registration of medical device products in our province will be more perfect and more suitable for the development of the medical device industry in the future.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R955

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