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中国生物工程杂志

CHINA BIOTECHNOLOGY
中国生物工程杂志
中国生物工程杂志  2023, Vol. 43 Issue (2/3): 174-179    DOI: 10.13523/j.cb.2211049
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真实世界证据与医疗器械监管决策支持
杜瑶,王颖,杨葳*(),杨慧,田殿祥
天津市医疗器械审评查验中心 天津 300191
Real World Evidence and Decision Support of Medical Device Supervision
DU Yao,WANG Ying,YANG Wei*(),YANG Hui,TIAN Dian-xiang
Tianjin Medical Device Evaluation and Inspection Center,Tianjin 300191,China
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摘要：

近年来,我国关于真实世界的研究进展受到广泛关注,相关监管政策规定也在日益完善,但是有关医疗器械领域的文献并不多见。从国内外真实世界研究监管法规的政策背景出发,结合真实世界数据在医疗器械临床评价的应用情况,重点探讨真实世界证据用于支持医疗器械监管决策的关键要素,同时提出面临的机遇与挑战,以期为推动真实世界证据用于支持医疗器械监管决策提供参考。
关键词： 真实世界数据;  真实世界证据;  真实世界研究;  医疗器械;  监管决策    
Abstract:

In recent years, China’s research progress on real world study has received widespread attention, and the relevant regulatory policies and regulations are also modified and improved on a regular basis, but the relevant literature in the field of medical devices is rare. Starting from the policy background of domestic and foreign real world evidence for regulatory decision-making, this paper focuses on the key elements of real world evidence used to support medical device regulatory decisions in combination with the application of real world data in clinical evaluation of medical devices. It also discusses the opportunities and challenges, with a view to providing reference for promoting real world evidence used to support medical device regulatory decisions.
Key words: Real world data    Real world evidence    Real world study    Medical device    Regulatory decision
收稿日期: 2022-11-22 出版日期: 2023-03-31
ZTFLH:  Q819  
通讯作者: *杨葳     E-mail: 1157956361@qq.com
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杜瑶
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田殿祥

引用本文:

杜瑶, 王颖, 杨葳, 杨慧, 田殿祥. 真实世界证据与医疗器械监管决策支持[J]. 中国生物工程杂志, 2023, 43(2/3): 174-179.

DU Yao, WANG Ying, YANG Wei, YANG Hui, TIAN Dian-xiang. Real World Evidence and Decision Support of Medical Device Supervision. China Biotechnology, 2023, 43(2/3): 174-179.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.2211049    或    https://manu60.magtech.com.cn/biotech/CN/Y2023/V43/I2/3/174

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