[医疗器械注册材料技术审评探讨]
[Discussion on Technical Evaluation for Medical Device Registration Material].
作者信息
Chu Yungao, Qian Hong, Zhu Yingfeng
机构信息
Center for Certification & Evaluation, SHFDA, Shanghai, 200020.
出版信息
Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Jul 30;41(4):286-288. doi: 10.3969/j.issn.1671-7104.2017.04.014.
Abstract
This article first introduces the main contents of the requirements for medical device registration. Secondly, this article chooses the vertebral forming surgery system as an example to discuss the technical evaluation for the registration research material. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluator who make the evaluation for the medical device registration.
摘要
本文首先介绍医疗器械注册要求的主要内容。其次，本文以椎体成形手术系统为例，探讨注册研究资料的技术审评。本文希望能为准备注册资料的申请人以及进行医疗器械注册审评的技术审评人员提供参考。
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