Cai Lixian, Chang Limei, Li Yaohua, Zhu Ming, Zhang Hui
Hainan Center for Drug and Medical Device Evaluation and Service, Haikou, 570216.
Center for Medical Device Evaluation, NMPA, Beijing, 100081.
Zhongguo Yi Liao Qi Xie Za Zhi. 2023 Jan 30;47(1):83-88. doi: 10.3969/j.issn.1671-7104.2023.01.015.
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.
海南博鳌乐城国际医疗旅游先行区的真实世界数据具有支持医疗器械上市前临床评价的优势。基于医疗器械临床评价的相关要求，结合前期试点器械的实践经验，从审评角度探讨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。同时，提出真实世界研究设计中应考虑的要素及数据质量评价方式。期望提供参考，以便注册申请人合理运用真实世界数据，助力医疗器械上市注册申报。
