中国医疗器械杂志
   
  
   首页 |  期刊介绍 |  编 委 会 |  投稿指南 |  期刊订阅 |  留言板 |  联系我们 | 
中国医疗器械杂志 2020, Vol. 44 Issue (4) :334-337    DOI: 10.3969/j.issn.1671-7104.2020.04.012
监管与测试 最新目录 | 下期目录 | 过刊浏览 | 高级检索 << Previous Articles | Next Articles >>
基于医疗器械注册审评流程的风险分析及其对策探讨
蓝翁驰,孙磊,范睿
国家药品监督管理局医疗器械技术审评中心,北京市,100081
Risk Analysis and Countermeasures Investigating Based on Medical Device Registration Review Process
LAN Wengchi, SUN Lei, FAN Rui
Center for Medical Device Evaluation, NMPA, Beijing, 100081

摘要
参考文献
相关文章
Download: PDF (0KB)   HTML 1KB   Export: BibTeX or EndNote (RIS)      Supporting Info
摘要 为了加强对医疗器械的监督管理,我国对医疗器械产品实行上市前注册审批制度,其中,技术审评是我国 医疗器械注册管理制度中的关键技术环节。以流程为导向,系统梳理了审评流程中各环节存在的风险,并 提出风险防范的对策建议,以期强化对审评全过程的质量控制,有效实现审评质量和效率的提升,保障医 疗器械审评审批制度各项改革举措落地生效。
Service
把本文推荐给朋友
加入我的书架
加入引用管理器
Email Alert
RSS
作者相关文章
关键词医疗器械   审评流程   风险分析     
Abstract: In order to strengthen the supervision and management of medical devices, China implements premarket registration and approval system for medical device. Technical evaluation is a key point of Chinese medical device registration management system. This study, by process-oriented, systematically sorts out the risks existing in each part of the review process. The countermeasures for risk prevention are proposed, hoping to strengthen the quality control of the whole process of review, improve the quality and efficiency of the review effectively, and ensure the various reform measures of the medical device review and approval system effectively.
Keywords:   
Received 2019-11-27;
About author: 蓝翁驰,E-mail:lanwch@cmde.org.cn
引用本文:   
蓝翁驰,孙磊,范睿.基于医疗器械注册审评流程的风险分析及其对策探讨[J]  中国医疗器械杂志, 2020,V44(4): 334-337
LAN Wengchi, SUN Lei, FAN Rui.Risk Analysis and Countermeasures Investigating Based on Medical Device Registration Review Process[J]  Chinese Journal of Medical Instrumentation, 2020,V44(4): 334-337
Copyright 2010 by 中国医疗器械杂志