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中国生物工程杂志

China Biotechnology
China Biotechnology
China Biotechnology  2023, Vol. 43 Issue (2/3): 174-179    DOI: 10.13523/j.cb.2211049
    
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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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     
Received: 22 November 2022      Published: 31 March 2023
ZTFLH:  Q819  
Corresponding Authors: *Wei YANG     E-mail: 1157956361@qq.com
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Yao DU
Ying WANG
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Hui YANG
Dian-xiang TIAN
Cite this article:

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.

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

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