Please use this identifier to cite or link to this item: https://ah.lib.nccu.edu.tw/handle/140.119/89071
題名: 中國大陸醫療器材法規與監督管理制度之研究
A Study on Regulations for the Supervision and Administration of Medical Devices in China
作者: 尹其言
Yin, Chi Yen
貢獻者: 王文杰
Wang, Wen Chieh
尹其言
Yin, Chi Yen
關鍵詞: 醫療器材法律體系
醫療器材法規制度
醫療器材監督管理
regulations of medical devices
rules of medical device
supervisory and administration of medical devices
日期: 2016
上傳時間: 2-May-2016
摘要: 醫療器材法律規章與監督管理制度的探討,能夠教育社會大眾遵守法律、保障醫療器材產品品質、維持市場公平競爭、保障人們使用安全和身體健康。進而對於整體醫療器材產業,可以在面對法律問題之前的法律責任、行為規則、違法情形以及類推適用作為憑據和參考。\n本研究目的是(1)檢視中國大陸醫療器材法律規章之起源與形成由來。(2)瞭解中國大陸醫療器材監督管理制度的發展情況。(3)探討中國大陸醫療器材監督管理相對人違法責任與違法處罰行為。\n本研究主要以「內容分析法」,從中英文參考書籍、學術論文以及相關市場報告、期刊文章等,蒐集具有醫療器材相關的法學理論、法規制度、監督管理等關聯性資料加以歸納整理並進行討論。其次,採用「比較分析法」,將歐盟、日本、中華民國以及美國之醫療器材法規和監督管理制度與中國大陸進行對比分析。本研究以中國大陸醫療器材法律體系、法規制度和監督管理三項研究構面進行觀察,期許呈現符合學術標準的信度與效度之研究結果。\n研究結果發現,中國大陸《醫療器械監督管理條例》屬於「行政法規」層級。監督管理的方式主要為「產品上市前審查」與「產品上市後監督」。其中「產品上市前審查」需要遵循:(a)醫療器材檢測管理、(b)醫療器材註冊管理、(c)醫療器材生產管理、(d)醫療器材說明書、標籤和包裝管理與(e)醫療器材經營管理;「產品上市後監督」必須恪守:(f)醫療器材使用管理、(g)醫療器材廣告管理、(h)醫療器材進出口管理、(i)醫療器材不良事件監測管理、(j)醫療器材召回管理、(k)醫療器材監督檢查和(l)醫療器材行政處罰等各項法規與條例。\n研究結論歸納,2014年最新修訂的中國大陸《醫療器械監督管理條例》主要是:(1)風險管理分級、(2)審查制度精簡、(3)產品流向追蹤、(4)監管功能強化以及(5)明確法律責任。
This study aimes to determine the regulations for the supervision and administration of medical devices which is able to educate citizen to complying with the law, ensuring the quality of medical products, maintaining fair competition in the market, protecting the safety and health of people utilization. Furthermore, according to the breadth and complexity of the industry, this proposal can be directed rules as reference in case encountered juridic liability, legal issues or wrongful circumstances before acquired appreciable support from counsellor.\nThe research topics of this article are (1) Examining the draft laws, regulations and rules and policy plots on the governance of medical devices in China. (2) Understanding the development of medical devices regulatory system in China. (3) Exploring the regulatory responsibility of medical devices and penalize illegal behavior in China.\nContent analysis methodology was conducted for this overview, this writings evaluated regulations of medical devices and administrative institution. Quality system regulations were also investigated by the comparative analysis along with China, European Union, Japan, Taiwan, R.O.C. and the United States.\nResults reveal that the regulations of medical devices are belong to administrative statute level, the supervision of meical devices is divided to pre-market review and post-market surveillance. Pre-market review contains (a) inspection management, (b) registered management, (c) production management, (d) manuals, labeling and packaging management and (e) advertisement management. Post-market surveillance embodies (f) the application of medical devices management, (g) medical devices advertising management, (h) medical devices import and export management, (i) medical devices monitoring and management of adverse events, (j) medical devices recall management, (k) supervision and inspection of medical dvices together with (l) medical devices regulations and administrative penalties, and other regulations.\nThe findings were summarized as the following statements, the essentials on the latest revised regulations for the supervision and administration of medical devices in China in 2014 are (1) risk based classification, (2) market notification and approval, (3) products sales tracking, (4) supervisory functions strength and (5) distinct legislative liability.
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Fraser, A.G., Daubert, J-C., Van de Werf, F., Mark Estes III, N.A., Smith Jr., S.C., Krucoff, M.W., Vardas, P.E. and Komajda, M., on behalf of the participants., Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform Report of a policy conference of the European Society of Cardiology, 32 EUROPEAN HEART JOURNAL (2011).\n12. French-Mowat, E. & Burnett, J., How are medical devices regulated in the European Union? 105 JOURNAL OF THE ROYAL SOCIETY OF MEDICINE (20120.\n13. Horton, L.R., Medical device regulation in the European Union, 50 FOOD AND DRUG LAW JOURNAL (1995).\n14. Kaganov, A.L., Medical device development - innovation versus regulation, 29 ANNALS OF THORACIC SURGERY (1980).\n15. Kahan, J.S., The evolution of fda regulation of new medical device technology and product applications, 41 FOOD AND DRUG LAW JOURNAL (1986).\n16. 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描述: 碩士
國立政治大學
法學院碩士在職專班
102961053
資料來源: http://thesis.lib.nccu.edu.tw/record/#G0102961053
資料類型: thesis
Appears in Collections:學位論文

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