摘 要
醫療器械是關系到人民群眾身體健康，甚至于生命安全的特殊商品，它被廣泛應用于疾病預防、診斷、治療、監護、緩解、補償等很多方面，已經成為醫療衛生服務的重要組成部分。隨著科技的發展，多領域的新技術在醫療領域廣泛應用，由醫療器械產品質量問題帶來的不良事件也逐年增加，給醫療器械監管帶來新的挑戰。
面對問題和挑戰，政府監管部門必須不斷地轉變監管理念，創新監管方式，改進監管措施，全面提高監管水平。
本文從醫療器械產品的特殊性入手，回顧我國醫療器械監管的發展歷程，研究和分析我國及湘潭市醫療器械行業發展狀況和監管體制，概括地介紹歐美醫療器械監管現狀及其特點，并與我國現行的醫療器械監管體系進行比較研究，尋找彼此之間的差異，進而總結經驗，得到啟迪。運用公共管理的相關理論，積極探索醫療器械監管的新模式，結合吉林省醫療器械行業發展狀況及監管工作的實際情況，提出既可以促進醫療器械行業持續健康快速發展，又能保證產品質量安全的監管對策。
全文有六個部分。第一個部分是緒論，主要是對本文的選題背景、研究目的與意義、國內外監管現狀、研究思路和主要內容和研究方法和創新點進行必要說明。
第二個部分介紹了本研究的理論分析，包括醫療器械監管的涵義、醫療器械監管的作用和醫療器械監管的理論基礎，如政府責任理論、市場失靈和政府失靈理論等。
第三部分醫療器械監管中存在的問題—以湘潭市為例。全面剖析了醫療器械監管的歷史，認真分析了湘潭市醫療器械行業的現狀，提出了湘潭市醫療器械監管中存在的問題，并明確指出了這些問題的成因。第四部分國內外醫療器械監管經驗借鑒，其中包括：國內醫療器械監管的先進模式和國際醫療器械監管的先進模式。第五部分就醫療器械監管提出相應對策對策，包括提高監管待遇，加強業務培訓，打造專業團隊、制定相關制度，改變監管模式、加大資金投入，完善基礎建設、加強技術支持和加強信息化建設，與時代接軌。第六部分根據現實情況分析，作出有關結論。
關鍵詞：醫療器械；監管；對策
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 錄
第 1 章 緒 論
1.1 選題背景
1.2 研究目的與意義
1.3 國內外研究現狀
1.3.1 國外研究現狀
1.3.2 國內研究現狀
1.3.3 簡要評價
1.4 研究思路和主要內容
1.5 研究方法和創新點
第 2 章 醫療器械監管的理論分析
2.1 醫療器械監管的涵義
2.2 醫療器械監管的作用
2.3 醫療器械監管的理論基礎
2.3.1 政府責任理論
2.3.2 市場失靈和政府失靈理論
第 3 章 醫療器械監管中存在的問題——以湘潭市為例
3.1 醫療器械監管的歷史
3.1.1 醫療器械的歷史
3.1.2 發達國家醫療器械監管的發展歷程
3.1.3 我國對醫療器械監管的歷史沿革
3.2 湘潭市醫療器械行業的現狀
3.2.1 基本情況
3.2.2 產業現狀
3.2.3 監管情況
3.3 湘潭市醫療器械監管存在的問題
3.3.1 對醫療器械監管的思想認識不足
3.3.2 監管部門重疊，多頭管理
3.3.3 監管隊伍素質有待提高
3.4 湘潭市醫療器械監管存在問題的原因
3.4.1 監管法規不完善……19
3.4.2 信息化建設落后
3.4.3 技術支持不足
第 4 章 國內外醫療器械監管經驗借鑒
4.1 國內醫療器械監管的先進模式
4.1.1 內蒙古自治區巴彥淖爾市
4.1.2 黑龍江省伊春市
4.2 國際醫療器械監管的先進模式
第 5 章 完善醫療器械監管的對策
5.1 提高監管待遇，加強業務培訓，打造專業團隊
5.2 制定相關制度，改變監管模式
5.2.1 減少行政審批，建設服務型政府部門
5.2.2 完善醫療器械行業的功能
5.2.3 引入第三方認證、審評機構
5.2.4 轉變監管模式，積極探索有效的監管體制
5.3 加大資金投入，完善基礎建設
5.4 加強技術支持
5.5 加強信息化建設，與時代接軌
第 6 章 結論與展望
參考文獻
致 謝
