培训课件_中国创新医疗器械特别审批程序介绍顾汉卿.ppt

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 Devices, the?applicant?will?be?informed of?the?result?in writing. On the application of domestic enterprises, send a copy to provincial food and drug supervision and administration department in the applicants’ location at the same time. 创新医疗器械审查办公室在审查创新医疗器械特别审批申请时一并对医疗器械管理类别进行界定。 Along with the review of?the applications for special approval of innovative medical devices by the Office of Innovative Medical Devices, define the management category of medical devices. 创新医疗器械特别审批截止6月30日，已有247个产品申请32个产品获批准,尚有4个产品即将公告。 As of June 30 for special approval of innovative medical devices, 247 products were applied,32 products were approved, 4 products are announced soon. 由于本项目的审评工作2014年3月才开始，中国食品药品监管局欢迎和世界各地的企业合作搞好创新医疗器械特别审批工作，欢迎多提建议和意见，改进工作。 Since the evaluation of project began in March 2014, SFDA welcome partners from all over the world do a good job of the special approval of innovative medical devices. Welcome more opinions and suggestions for the improvement. 中国创新医疗器械特别审批程序介绍Introduction to Special Approval Procedure on China’s Innovative Medical Devices 中国生物医学工程学会 顾汉卿 Chinese Society of Biomedical Engineering Gu Hanqing 随着科学技术的进步，医疗器械在临床疾病的预防、诊断、治疗中的作用越来越显得重要。为了鼓励医疗器械的研究与创新，让更多创新的高科技医疗器械快速受惠于普通百姓，中国食品药品监督管理局颁布了《创新医疗器械特别审批程序（试行）》。 With the progress of science and technology, medical devices in the role of clinical disease prevention, diagnosis, and treatment is more and more i