[Status Analysis and Improvement Suggestions on the Renew Registration of Passive Medical Devices].
作者信息
Hou Dandan, Chu Yungao, Zhong Zhizhen
机构信息
Center for Certification & Evaluation of SHFDA, Shanghai, 200020.
出版信息
Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Sep 30;42(5):375-377. doi: 10.3969/j.issn.1671-7104.2018.05.018.
Abstract
The article collected 250 renew registration of domestic Class Ⅱ passive medical devices from Jan. 2016 to Aug. 2017 in Shanghai. It summarized the common problems listed in the correction notifications of the technical evaluation, and then provides some relevant countermeasures or suggestions. So that we can further speed up the evaluation and approval of medical devices.
摘要
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