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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2025, Vol. 30 ›› Issue (1): 131-137.doi: 10.12092/j.issn.1009-2501.2025.01.016

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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

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

CLC Number: