中国医疗器械杂志2024，Vol.48Issue(1) ：85-87.DOI:10.3969/j.issn.1671-7104.230219

上海市第二类创新医疗器械特别审查申请常见问题和改进建议

Common Problems and Improvement Suggestions for the Special Review Application of Shanghai's Class Ⅱ Innovative Medical Device

谢琼
中国医疗器械杂志2024，Vol.48Issue(1) ：85-87.DOI:10.3969/j.issn.1671-7104.230219
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  • 维普
  • 万方数据

上海市第二类创新医疗器械特别审查申请常见问题和改进建议

Common Problems and Improvement Suggestions for the Special Review Application of Shanghai's Class Ⅱ Innovative Medical Device

谢琼1
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作者信息

  • 1. 上海市医疗器械化妆品审评核查中心,上海市,200020
  • 折叠

摘要

该研究通过统计2020年4月至2023年4月上海市第二类创新医疗器械特别审查申请情况,汇总分析了创新审查申请阶段的常见问题,并给出改进建议,供申请人和审查人员参考,以期进一步提高创新申请资料质量,提高创新申请的通过率.

Abstract

This study conducted statistics on the special review applications for Class Ⅱ innovative medical devices in Shanghai from April 2020 to April 2023.It summarized and analyzed common problems in the innovation review application stage,and gave suggestions for applicants and reviewers in order to further improve the quality of innovation application and improve the pass rate of innovation applications.

关键词

第二类创新医疗器械/审查/常见问题

Key words

Class Ⅱ innovative medical device/review/common problems

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出版年

2024
中国医疗器械杂志
上海市医疗器械检测所

中国医疗器械杂志

CSTPCD
影响因子：0.503
ISSN：1671-7104
参考文献量1
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