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

Qiong Xie
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引用次数: 0

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.

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[上海市Ⅱ类创新医疗器械专项审评申请常见问题及改进建议]。
本研究对2020年4月至2023年4月上海市Ⅱ类创新医疗器械专项审评申请情况进行了统计。本研究对2020年4月至2023年4月期间上海市第Ⅱ类创新医疗器械专项审评申请情况进行了统计,总结分析了创新审评申请阶段的常见问题,并对申请人和审评员提出了建议,以期进一步提高创新申请质量,提高创新申请通过率。
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来源期刊
中国医疗器械杂志
中国医疗器械杂志 Medicine-Medicine (all)
CiteScore
0.40
自引率
0.00%
发文量
8086
期刊介绍: Chinese Journal of Medical Instrumentation mainly reports on the development, progress, research and development, production, clinical application, management, and maintenance of medical devices and biomedical engineering. Its aim is to promote the exchange of information on medical devices and biomedical engineering in China and turn the journal into a high-quality academic journal that leads academic directions and advocates academic debates.
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