论文总字数：19606字

摘 要

医疗器械临床试验在我国受重视程度一直不高，近几年医疗改革过程中，随着相关法律法规的面世对医疗器械临床试验的关注度逐渐增加。本文通过详细叙述医疗器械临床试验开展流程，分析我国医疗器械临床试验监管现状、医疗器械临床试验在医疗机构的实施情况、以及医疗器械临床试验中外包服务、医疗器械生产厂家的作用，分析医疗器械临床试验实施的现状，剖析目前我国医疗器械临床试验实施过程中存在的监管不严、国内对医疗器械临床试验重视度不够、人员培训不完善、临床试验操作流程不严谨等各项问题。并通过对文献的解读，结合实习工作的经验对这些问题提出建议，以期修正行业风气，填补医疗器械临床试验监管漏洞，提高行业对医疗器械临床试验重视度，完善相关各项体制，使我国医疗器械临床试验体系进一步完整化、规范化，从而使得医疗器械临床试验真正做到科学、可靠，以保证医疗器械安全性和有效性。

关键词：医疗器械；临床试验；合同研究组织；临床监察员

Current situation and thinking of clinical trials of medical instruments in China

Abstract

The clinical trials of medical devices in our country by the degree of attention is not high, in the process of medical reform in recent years, with the introduction of relevant laws and regulations of clinical trials of medical devices increasing attention. This paper describes the clinical trial of medical devices to carry out process, analysis of clinical trials of medical devices regulatory status quo of China"s medical devices, clinical trials in the medical institutions of the implementation of the medical devices in clinical trials and outsourcing services, medical equipment manufacturers, analysis of the current situation of medical device clinical trial implementation, analysis of current medical Pro The test bed implementation process in the presence of lax supervision, domestic clinical trials of medical devices do not pay enough attention, staff training is not perfect, not rigorous clinical trial operation process and other issues. And through the interpretation of the literature, combined with practical work experience and puts forward proposals to these problems, in order to revise the industry trend, fill in medical device clinical trials of regulatory loopholes, improve the industry of clinical trials of medical devices related to the degree of attention, improve the system, the medical device clinical trial system of our country further complete, standardized, so that the medical device clinical trials truly scientific, reliable, in order to ensure the safety and effectiveness of medical device.

Keywords: Medical Devices; Clinical Trials; CRO; CRA

目 录

摘 要 I

Abstract II

第一章 引 言 1

1.1 研究背景 1

1.1.1 我国医疗器械之现状 1

1.1.2 医疗器械临床试验与药物临床试验的区别 2

1.2 研究意义 2

1.3 研究内容 3

第二章 医疗器械临床试验开展流程 4

2.1 方案拟定阶段 4

2.2 伦理审批阶段 4

2.3 启动阶段 4

2.4 临床试验开展阶段 4

2.5 临床试验统计总结阶段 5

第三章 我国医疗器械临床试验监管现状 6

3.1 我国医疗器械法律法规 6

3.1.1 我国医疗器械法律法规发展 6

3.1.2 我国医疗器械临床试验现有法律法规 6

3.2 我国医疗器械监管现存问题 7

3.2.1 临床试验机构资格认定制度不完善 7

3.2.2 培训考核制度松散 7

3.3.3 监管不到位 8

第四章 我国医疗器械临床试验在医疗机构的现状 9

4.1 伦理委员会 9

4.2 人员 9

4.2.1 人员培训 9

4.2.2 研究者 10

4.2.3 相关医护人员 10

4.2.4 检验人员 10

4.3 试验用医疗器械管理 10

4.4 试验样品保存 11

第五章 申办者实施医疗器械临床试验现状 12

5.1 我国医疗器械临床试验外包服务现状 12

5.1.1 合同研究组织（CRO） 12

5.1.2 临床监察员（CRA） 12

5.2 医疗器械生产厂家 14

第六章 总结与展望 15

致 谢 16

参考文献 17

第一章 引 言

1.1 研究背景

1.1.1 我国医疗器械之现状

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