摘 要
医疗器械是关系到人民群众身体健康，甚至于生命安全的特殊商品，它被广泛应用于疾病预防、诊断、治疗、监护、缓解、补偿等很多方面，已经成为医疗卫生服务的重要组成部分。随着科技的发展，多领域的新技术在医疗领域广泛应用，由医疗器械产品质量问题带来的不良事件也逐年增加，给医疗器械监管带来新的挑战。
面对问题和挑战，政府监管部门必须不断地转变监管理念，创新监管方式，改进监管措施，全面提高监管水平。
本文从医疗器械产品的特殊性入手，回顾我国医疗器械监管的发展历程，研究和分析我国及湘潭市医疗器械行业发展状况和监管体制，概括地介绍欧美医疗器械监管现状及其特点，并与我国现行的医疗器械监管体系进行比较研究，寻找彼此之间的差异，进而总结经验，得到启迪。运用公共管理的相关理论，积极探索医疗器械监管的新模式，结合吉林省医疗器械行业发展状况及监管工作的实际情况，提出既可以促进医疗器械行业持续健康快速发展，又能保证产品质量安全的监管对策。
全文有六个部分。第一个部分是绪论，主要是对本文的选题背景、研究目的与意义、国内外监管现状、研究思路和主要内容和研究方法和创新点进行必要说明。
第二个部分介绍了本研究的理论分析，包括医疗器械监管的涵义、医疗器械监管的作用和医疗器械监管的理论基础，如政府责任理论、市场失灵和政府失灵理论等。
第三部分医疗器械监管中存在的问题—以湘潭市为例。全面剖析了医疗器械监管的历史，认真分析了湘潭市医疗器械行业的现状，提出了湘潭市医疗器械监管中存在的问题，并明确指出了这些问题的成因。第四部分国内外医疗器械监管经验借鉴，其中包括：国内医疗器械监管的先进模式和国际医疗器械监管的先进模式。第五部分就医疗器械监管提出相应对策对策，包括提高监管待遇，加强业务培训，打造专业团队、制定相关制度，改变监管模式、加大资金投入，完善基础建设、加强技术支持和加强信息化建设，与时代接轨。第六部分根据现实情况分析，作出有关结论。
关键词：医疗器械；监管；对策
Abstract
Medical Devices is related to people's health, and even the lives of specialcommodity, it is widely used in disease prevention, many aspects of diagnosis, treatment,monitoring, mitigation, compensation, etc., have become an important part of healthservices. With the development of science and technology, new technology is widely usedin many fields in the medical field, adverse events by the medical device product qualityproblems caused by increased year by year, to medical device regulation has brought newchallenges. Faced with problems and challenges, government regulators must continuallychanging regulatory philosophy, innovative forms of regulation, improve the regulatorymeasures, and comprehensively improve the level of supervision.
In this paper, we review the development of medical device supervision, research andanalyze the development status and supervision system of medical devices industry inChina and Xiangtan, summarize the status quo and characteristics of European andAmerican medical devices, and compare the differences between them. Using the relevanttheory of public management, and actively explore new mode of medical devicesupervision, combined with the actual situation of the development of medical devicesindustry in Jilin province and the actual situation of the supervision work, proposed thatcan promote the continuous and healthy development of the medical device industry, andcan guarantee the product quality and safety supervision measures.
There are six full part. The first part is an introduction, mainly on paper background,purpose and significance, the regulatory status quo at home and abroad, research ideas andthe main content and research methods and innovations necessary instructions. The secondpart describes the theoretical analysis of this study, including medical device regulatorymeaning, the role of medical supervision and theoretical basis for regulation of medicaldevices, such as government responsibility theory, market failure and government failuretheory. The third part of the medical device regulatory problems exist - in Xiangtan City. Acomprehensive analysis of the medical supervision of history, a careful analysis of thecurrent situation in Xiangtan City, the medical device industry, presented in Xiangtan CityMedical Device Regulatory problems and made clear that the causes of these problems.
Part IV medical supervision at home and abroad learn from experience, including: thedomestic medical device regulatory advanced mode and international medical deviceregulatory advanced mode. The fifth part corresponding countermeasures countermeasureon medical supervision, including improved regulatory treatment, strengthen professionaltraining, to build a professional team, a set of policies, changes in the regulatory model,increase capital investment, improve infrastructure, strengthen technical support andenhance information technology , and the era of convergence. Part VI of the analysisbased on the reality and make relevant conclusions.
目 录
第 1 章 绪 论
1.1 选题背景
1.2 研究目的与意义
1.3 国内外研究现状
1.3.1 国外研究现状
1.3.2 国内研究现状
1.3.3 简要评价
1.4 研究思路和主要内容
1.5 研究方法和创新点
第 2 章 医疗器械监管的理论分析
2.1 医疗器械监管的涵义
2.2 医疗器械监管的作用
2.3 医疗器械监管的理论基础
2.3.1 政府责任理论
2.3.2 市场失灵和政府失灵理论
第 3 章 医疗器械监管中存在的问题——以湘潭市为例
3.1 医疗器械监管的历史
3.1.1 医疗器械的历史
3.1.2 发达国家医疗器械监管的发展历程
3.1.3 我国对医疗器械监管的历史沿革
3.2 湘潭市医疗器械行业的现状
3.2.1 基本情况
3.2.2 产业现状
3.2.3 监管情况
3.3 湘潭市医疗器械监管存在的问题
3.3.1 对医疗器械监管的思想认识不足
3.3.2 监管部门重叠，多头管理
3.3.3 监管队伍素质有待提高
3.4 湘潭市医疗器械监管存在问题的原因
3.4.1 监管法规不完善……19
3.4.2 信息化建设落后
3.4.3 技术支持不足
第 4 章 国内外医疗器械监管经验借鉴
4.1 国内医疗器械监管的先进模式
4.1.1 内蒙古自治区巴彦淖尔市
4.1.2 黑龙江省伊春市
4.2 国际医疗器械监管的先进模式
第 5 章 完善医疗器械监管的对策
5.1 提高监管待遇，加强业务培训，打造专业团队
5.2 制定相关制度，改变监管模式
5.2.1 减少行政审批，建设服务型政府部门
5.2.2 完善医疗器械行业的功能
5.2.3 引入第三方认证、审评机构
5.2.4 转变监管模式，积极探索有效的监管体制
5.3 加大资金投入，完善基础建设
5.4 加强技术支持
5.5 加强信息化建设，与时代接轨
第 6 章 结论与展望
参考文献
致 谢
