Abstract：By investigating the application status and supervision of implantable retinal prosthesis system at home and abroad, the
regulatory policy and registration review considerations of this rare disease treatment equipment were clarified. The related
requirements of preclinical research, clinical trials and operator's instructions were clarified. It is helpful for the products to be
marketed as soon as possible and benefit the patients with rare diseases.
张宇晶，刘露，许伟. 植入式视网膜电刺激系统的应用进展
及注册审评考虑[J]. 中国医疗设备, 2019, 34(9): 161-163.
ZHANG Yujing, LIU Lu, XU Wei. Progress in the Application of Implantable Retinal Electrical Stimulation System
and Consideration of Registration Review. China Medical Devices, 2019, 34(9): 161-163.
