博鳌乐城先行区真实世界数据支持医疗器械上市前临床评价的应用探讨

Discuss Application of Real-world Data from the Boao Lecheng Pilot Zone to Support Premarket Clinical Evaluation of Medical Device

海南博鳌乐城国际旅游先行区真实世界数据,具有支持医疗器械注册上市前临床评价的优势。该研究结合医疗器械临床评价相关要求,基于前期试点器械的实践经验,从审评角度对博鳌乐城真实世界数据在医疗器械上市前临床评价路径中的应用进行探讨,提出真实世界研究设计应考虑的要素及数据质量评价方式,以期为注册申请人合理使用真实世界数据助力申报器械注册上市提供参考。

The real-world data of Hainan Boao Lecheng International Tourism Pilot Zone has the advantage of supporting pre-market clinical evaluation of medical devices.Based on the relevant requirements of clinical evaluation of medical devices and based on the practical experience of pilot devices in the early stage,the application of Boao Lecheng real-world data in the pre-market clinical evaluation path of medical devices from the perspective of review is discussed.At the same time,the elements that should be considered in real-world study design and the way of data quality evaluation are proposed.Expect to provide a reference in order to allow registration applicants to use real world data wisely to help declare device registration for marketing.