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中国临床药理学与治疗学 ›› 2025, Vol. 30 ›› Issue (1): 131-137.doi: 10.12092/j.issn.1009-2501.2025.01.016

• 综述与讲座 • 上一篇    下一篇

2016-2023医疗器械临床试验监督抽查结果中共性问题的分析与探讨

梁雨烟,季芳,潘莹,许诗瑶,杨抒,徐良   

  1. 国家药品监督管理局医疗器械技术审评检查大湾区分中心,深圳  518045,广东
  • 收稿日期:2024-03-27 修回日期:2024-04-22 出版日期:2025-01-26 发布日期:2025-01-02
  • 通讯作者: 徐良,男,硕士,正高级工程师,研究方向:医疗器械临床核查。 E-mail:xuliang@mdei.org.cn
  • 作者简介:梁雨烟,女,硕士,助理工程师,研究方向:医疗器械临床核查。 E-mail:liangyy@mdei.org.cn

Analysis and discussion of the common problems found in medical device clinical trials inspection results from 2016 to 2023

LIANG Yuyan, JI Fang, PAN Ying, XU Shiyao, YANG Shu, XU Liang   

  1. Greater Bay Area Center for Medical Device Evaluation and Inspection?of?National Medical Products Administration,?Shenzhen 518045, Guangdong, China
  • Received:2024-03-27 Revised:2024-04-22 Online:2025-01-26 Published:2025-01-02

摘要: 本文通过收集2016—2023年医疗器械临床试验监督抽查结果,按照体外诊断试剂和医疗器械分别进行临床试验检查共性问题的分析探讨,同时提出临床试验各参与方可以采取的建议措施,以避免出现相似问题,保证临床试验质量。

关键词: 医疗器械, 临床试验, 监督抽查, 共性问题

Abstract:

By collecting inspection results from medical device clinical trials from 2016 to 2023, to analyze and discuss?common problems of clinical trials?from both?in vitro diagnostic reagents and medical devices, and propose the suggested measures taken by participants in the clinical trial, so as to avoid similar problems?occur?and ensure the quality of clinical trials.

Key words: medical device, clinical trials, inspection, common problems

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