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医疗器械安全有效性评价-对构建现行体制下医疗器械科学评价体系的探索
$43.31
医疗器械是高科技环保产业,是国家经济转型政策重点鼓励和扶植的高新技术产业发展方向。但目前的各项法规和制度安排尚未能够充分体现对行业的有效监管和促进作用。作者认为,首先需要改进现有的市场准入评价模式,建立中国自己的评价体系,以适应医疗器械行业发展的特点和要求。书中所提出的思路和理念是对现有法规和规范的建议、补充和完善,相信定会对促进法规的精细化、系统化、明确化和合理化产生深刻影响。作者希望通过这些思路和体念的提出,能为促进器械监管法规的进一步完善和提高科学化管理水平尽自己的绵薄之力。
另一方面,科学评价的原理和方法是科学监管的基础和重要组成部分。相信书中所提出的原理和方法必定能为政策制定者、执行者和实践者在制定和执行行业内政策时提供翔实和可操作性强的方案,并给以有价值的前瞻性参考。同时,在不违背科学原则的基础上,制定和形成具有我国特色的市场准人评价模式,提高行业管理质量和执行效率。作者诚恳希望所提出的观点和建议能被政策制定者所重视,并在政策制定过程中能够充分考虑本书所提出的建议和内容。也希望本书的出版和发行能为实现医疗器械科学评价作出应有的贡献。
医疗器械评价工作是个系统性工程。完整的医疗器械评价工作分为上市前的市场准入评价、上市或有条件上市后的跟踪、上市后不良反应的再评价。本书主要论述医疗器械上市前的市场准入评价和针对高风险器械的上市后跟踪。再评价涉及的不良反应报告和分析以及召回等处理程序不在本书重点论述范围之内。
周力田,籍贯湖南长沙,1964年生于北京,1987年毕业于浙江大学科学仪器系生物医学仪器专业,获得学士学位,2001年获得首都经贸大学工商管理专业在职硕士研究生学历。1997年至今,一直工作在国家食品药品监督管理局(前国家医药管理局、国家药品监督管理局)医疗器械技术审评中心。参与过次《医疗器械监督管理条例》和《医疗器械注册管理办法》的制定过程,提出过多项合理化建议并被采纳。具有15年以上的技术审评工作经历和专业知识,积累了丰富的医疗器械市场准入技术审评经验。
篇 医疗器械评价体系构建
章概述
节 医疗器械技术评价工作发展概况
第二节 存在的问题
第三节 总体思路
第二章分类审评框架思路的提出以及前提条件
第三章 与医疗器械评价有关的通行做法、基本认识、政策解读以及政策
期望
节通行做法
第二节 基本认识
第三节 政策解读
第四节 政策期望
第四章与评价及评价体系有关的定义
第五章建立基于医疗器械分类名录信息系统的注册和备案制度的必要性
第六章注册制度的适用情况及豁免条件
节 申请注册需要符合的条件
第二节 注册豁免的条件
第七章备案制度的适用情况
第二篇 开展临床研究(调查)的资质、条件、要求和必要性介绍
第八章基于器械分类审评模式的临床研究(调查)的一般要求
节 用于评价的分类
第二节 对六类器械临床和注册情况的说明
第三节 解释
第九章临床研究的适用性及其豁免
节 高风险创新性器械
第二节 中风险创新性器械
第三节 低风险创新性器械
……
第三篇 评价程序、方法、内容要求和其它
附录 美国食品药品监督管理局相关法规要求中一些重要章节的原文及部分中文节译
参考文献
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