中国创新医疗器械特别审批程序顾汉卿材料.pptVIP

经创新医疗器械审查办公室审查，对拟进行特别审批的申请项目，在食品药品监管总局医疗器械技术审评中心网站将申请人、产品名称予以公示，公示时间应当不少于10个工作日。对于有异议的，应当对相关意见研究后作出最终审查决定。 Reviewed by the Office for Innovative Medical Devices, for the proposed application on special approval, announce to the applicant and the product name in the website of Center for Medical Devices Evaluation of SFDA，publicity time?shall not be?less than 10 working days. For any objection, it shall, after advice to related research, make a decision on the final review. 创新医疗器械审查办公室作出审查决定后，将审查结果书面通知申请人，对境内企业的申请，同时抄送申请人所在地省级食品药品监督管理部门。 After reviewing by the Office of Innovative Medical Devi