Analysis and discussion of the common problems found in medical device clinical trials inspection results from 2016 to 2023
- VernacularTitle: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
- Author:
Yuyan LIANG
1
;
Fang JI
1
;
Ying PAN
1
;
Shiyao XU
1
;
Shu YANG
1
;
Liang XU
1
Author Information
- Publication Type:Journal Article
- Keywords: medical device; clinical trials; inspec-tion; common problems
- From: Chinese Journal of Clinical Pharmacology and Therapeutics 2025;30(1):131-137
- CountryChina
- Language:Chinese
- 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 mea-sures taken by participants in the clinical trial,so as to avoid similar problems occur and ensure the quality of clinical trials.
