Abstract：By comparing the new version and the old version of Standard for Quality Management of Medical Device Clinical Trials,
this paper interpreted the new edition of regulations from three aspects: the preparation stage of clinical trials, the protection of
subjects’ interests, and the construction of quality management system, so as to help practitioners better understand and comply with
the new regulation. Combined with the changes of the new regulation and the problems existing in clinical trials of medical devices,
the improvement measures were proposed from the perspective of sponsor, researchers, institutional offices and ethics, so as to
further improve the quality of clinical trials of medical devices.
潘辛梅，谢林利，马攀，谢江川，曹丽亚，陈勇川. 新版《医疗器械临床试验质量管理规范》
要点解读与思考[J]. 中国医疗设备, 2023, 38(4): 119-123.
PAN Xinmei, XIE Linli, MA Pan, XIE Jiangchuan, CAO Liya, CHEN Yongchuan. Interpretation and Discussion on the Key Points of the New Edition of Standard for Quality
Management of Medical Device Clinical Trials. China Medical Devices, 2023, 38(4): 119-123.
