真实世界证据与医疗器械监管决策支持

Real World Evidence and Decision Support of Medical Device Supervision

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。

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.