自测用血糖监测系统注册审评的探讨与监管建议

叶朝付^a，杨笑鹤^a，曾叶^b，寇艳芹^a，王宇航^a

Discussion and Suggestion on Registration and Evaluation of Blood Glucose Monitoring System for Self-Testing

YE Chaofu^a, YANG Xiaohe^a, ZENG Ye^b, KOU Yanqin^a, WANG Yuhang^a

中国医疗设备 . 2022, (4): 113 -116 . DOI: 10.3969/j.issn.1674-1633.2022.04.029