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中国医疗器械杂志 2019, Vol. 43 Issue (5) :362-364    DOI: 10.3969/j.issn.1671-7104.2019.05.014
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无菌医疗器械注册审评中对灭菌资料探讨
钱虹,储云高
上海市食品药品监督管理局认证审评中心,上海市,200020
Discussion on the Sterilization Material in the Registration Evaluation of Sterile Medical Device
QIAN Hong, CHU Yungao
Center for Certification & Evaluation, SHFDA, Shanghai, 200020

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摘要 该文首先简单介绍了无菌医疗器械注册审评时灭菌资料的法规要求,其次选取采用多种灭菌方式的软组织过线器套件作 为示例产品进行探讨,期望能够为医疗器械注册申请人准备注册资料和技术审评人员进行技术审评提供参考。
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关键词灭菌资料   技术审评   注册     
Abstract: This article first introduces the regulation requirements for sterilization material in the registration evaluation of sterile medical devices. Secondly, the article chooses the suture passer set kit with multiple sterilization methods as an example product for technical evaluation. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluators how to make the evaluation for the medical device registration.
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Received 2019-02-28;
About author: 钱虹,E-mail: qianhong@smda.sh.cn
引用本文:   
钱虹,储云高.无菌医疗器械注册审评中对灭菌资料探讨[J]  中国医疗器械杂志, 2019,V43(5): 362-364
QIAN Hong, CHU Yungao.Discussion on the Sterilization Material in the Registration Evaluation of Sterile Medical Device[J]  Chinese Journal of Medical Instrumentation, 2019,V43(5): 362-364
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