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国家食品药品监督管理总局令第18号《医疗器械使用质量监督管理办法》已经2015年9月29日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2016年2月1日起施行。局长毕井泉2015年10月21日医疗器械使用质量监督管理办法第一章总则第一条为加强医疗器械使用质量监督管理,保证医疗器械使用安全、有效,根据《医疗器械监督管理条例》,制定本办法。第二条使用环节的医疗器械质量管理及其监督管理,应当遵守本办法。第三条国家食品药品监督管理总局负责全
The State Food and Drug Administration Order No. 18 “Medical Device Quality Supervision and Management Measures” has been considered and approved by the State Council’s SFO on 29 September 2015, and is being announced as of February 1, 2016 Execution. Secretary Bi Jingquan October 21, 2015 Measures for the Quality Supervision and Administration of the Use of Medical Devices Chapter I General Provisions Article 1 In order to strengthen the quality supervision and administration of the use of medical devices and ensure the safe and effective use of medical devices, according to the Regulations on the Supervision and Administration of Medical Devices, Method. Article II of the use of medical device quality management and supervision and management, should comply with these measures. Article 3 The State Food and Drug Administration is responsible for the whole