| 简易呼吸器产品技术审评要点分析 |
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| 引用本文： | 马仁俊,朱廷玮,胡诚明.简易呼吸器产品技术审评要点分析[J].中国医疗器械信息,2020(5):4-5. |
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| 作者姓名： | 马仁俊 朱廷玮 胡诚明 |
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| 作者单位： | 福建省食品药品认证审评中心 |
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| 摘 要： | 简易呼吸器产品按照最新发布的医疗器械分类目录,属于第二类医疗器械管理.文章从简易呼吸器注册单元划分、综述资料、研究资料、技术要求、说明书等方面对该产品的技术审评要点进行了梳理和归纳,为产品注册申请人和相关审评人员提供参考.
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| 关 键 词： | 医疗器械 简易呼吸器 技术审评 |
Key Points Analysis of Simple Respirator |
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| MA Ren-jun,ZHU Ting-wei,HU Cheng-ming.Key Points Analysis of Simple Respirator[J].China Medical Devices Information,2020(5):4-5. |
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| Authors: | MA Ren-jun ZHU Ting-wei HU Cheng-ming |
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| Institution: | (Fujian Food and Drug Certification and Evaluation Center,Fujian Fuzhou 350003) |
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| Abstract: | According to the classification catalogue of medical devices,simple respriator brackets into the second category of medical equipment management.In this paper,the key points of technical review of simple respriator are sorted out and summarized from registration unit division,review data,research data,technical requirements,product manual and other aspects,so as to provide reference for product registration applicants and relevant reviewers. |
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| Keywords: | medical device simple respirator technical evaluation |
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