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医疗器械审评思路概述

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医疗器械技术审评是医疗器械注册的重要环节,本文阐述了《医疗器械安全和性能的基本原则》和《医疗器械风险管理对医疗器械的应用》在技术审评过程中的作用,厘清了如何科学地开展技术审评,以期供相关人员了解技术审评思路和审评关注点.
Overview of Medical Device Evaluation Ideas
Medical device evaluation plays very important role in the process of medical device registration.This article elaborates the role of"Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices"and"Medical devices-Application of Risk Management to Medical Devices"in the process of evaluation,as well as how to implement evaluation scientifically,so as to pro-vide relevant professionals with evaluation mindset and review focuses.

SafetyEffectiveEvaluationEssential principlesRisk management

陈敏、郭兆君

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国家药品监督管理局医疗器械技术审评中心,北京 100081

安全 有效 技术审评 基本原则 风险管理

2024

中国药物评价
国家食品药品监督管理局信息中心

中国药物评价

影响因子:1.09
ISSN:2095-3593
年,卷(期):2024.41(1)
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