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Order of the China Food and Drug Administration | | 国家食品药品监督管理总局令 |
(No.32) | | (第32号) |
The Decision of the China Food and Drug Administration on Adjusting the Approval Procedures of the Administrative Approval Items for Certain Medical Devices, as deliberated and adopted at the executive meeting of the China Food and Drug Administration on February 21, 2017, is hereby issued, and shall come into force on July 1, 2017. | | 《国家食品药品监督管理总局关于调整部分医疗器械行政审批事项审批程序的决定》已于2017年2月21日经国家食品药品监督管理总局局务会议审议通过,现予公布,自2017年7月1日起施行。 |
Director-General: Bi Jingquan | | 局长:毕井泉 |
March 20, 2017 | | 2017年3月20日 |
Decision of the China Food and Drug Administration on Adjusting the Approval Procedures of the Administrative Approval Items for Certain Medical Devices | | 国家食品药品监督管理总局关于调整部分医疗器械行政审批事项审批程序的决定 |
For purposes of implementing the Opinions of the State Council on Reforming the Examination and Approval System for Drugs and Medical Devices (No. 44 [2015], State Council) and the spirit of the State Council for the reform of the administrative approval system, further enhancing the administration of registration of medical devices, and effectively improving the review and approval efficiency, it has been decided upon deliberation at the executive meeting of the China Food and Drug Administration (“CFDA”) that the following decisions on the administrative approval for medical devices to be made by the CFDA have been adjusted to being made by the technical review center of medical devices under the CFDA in the name of the CFDA: ...... | | 为贯彻落实《国务院关于改革药品医疗器械审评审批制度的意见》(国发〔2015〕44号)以及国务院有关行政审批制度改革精神,进一步加强医疗器械注册管理,切实提高审评审批效率,经国家食品药品监督管理总局局务会议研究决定,将下列由国家食品药品监督管理总局作出的医疗器械行政审批决定,调整为由国家食品药品监督管理总局医疗器械技术审评中心以国家食品药品监督管理总局名义作出: ...... |
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