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[Status Analysis and Improvement Suggestions on Filing Review Trial Implementation of Shanghai's Class II Passive Medical Device Registration].

作者信息

Jiang Xin

机构信息

Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, 200020.

出版信息

Zhongguo Yi Liao Qi Xie Za Zhi. 2022 Jul 30;46(4):438-440. doi: 10.3969/j.issn.1671-7104.2022.04.018.

DOI:10.3969/j.issn.1671-7104.2022.04.018
PMID:35929162
Abstract

This article collected the statistics of Shanghai's class II passive medical device registration filing review trial implementation. It summarized and analyzed the common issues in the filing review stage, and gave suggestions for registration applicants and reviewers in order to further improve the quality of application materials and improve the efficiency of review.

摘要

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