Items related to 医疗器械注册共...
Synopsis
本书以医疗器械注册申报和技术审评过程中行政相对人提出频率较高且具有普遍代表意义的问题为基础，依据国家药品监督管理局医疗器械技术审评中心各审评部门职责，结合我国医疗器械法规、规章及规范性文件要求，对这些问题进行分析，形成共性问题解答。 本书按照医疗器械属性进行梳理分类，采用中英文对照方式进行展示，将共性问题所涉及的技术审评关键点加以解读，涉及相应问题与解答168个，涵盖有源医疗器械、无源医疗器械、体外诊断产品等，适用于从事各类医疗器械注册申报的行政相对人阅读使，对提高行政相对人注册申报质量具有较强的指导作用，对提升技术审评效率有着积极意义。
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Seller Image
Questions and Answers to Common Problems in Medical Device Registration(Chinese Edition)
ISBN 10: 7521419936
ISBN 13: 9787521419931
New
paperback
Seller: liu xing, Nanjing, JS, China
Seller rating 5 out of 5 stars
paperback. Condition: New. Language:Chinese.Paperback.Pub Date:2020-09-01 Pages:236 Publisher: China Medical Science and Technology Press This book is a guide book on the laws and regulations related to medical device registration. The content is gradual and it answers questions related to medical device registration before registration. .?There is strong guidance and applicability.?This book is suitable for the reading and use of medical device registration. production. operation license. daily supervision. and medica. Seller Inventory # NV037625