新修订的《医疗器械监督管理条例》(以下简称《条例》)已于2014年6月1日起施行。为配合《条例》的实施,在深入调研、多次论证、广泛征求各方意见的基础上,国家食品药品监督管理总局制修订了《医疗器械注册管理办法》、《体外诊断试剂注册管理办法》、《医疗器械说明书和标签管理规定》、《医疗器械生产监督管理办法》、《医疗器械经营监督管理办法》等五部规章。并已以国家食品药品监督管理总局令4、5、6、7、8号公布,将于2014年10月1日施行。新制修订的五部规章贯彻了党中央、国务院关于建立最严格的覆盖全过程的食品药品监管制度、加快政府职能转变和深化行政审批制度改革的精神,坚持风险治理、全程治理、社会治理、责任治理、效能治理等理 The newly revised “Regulations on the Supervision and Administration of Medical Devices” (the “Regulations”) came into effect on June 1, 2014. In order to cooperate with the implementation of the “Regulations”, on the basis of in-depth investigation, multiple argumentation and extensive solicitation of opinions from all parties, the State Food and Drug Administration made and revised the Measures for the Administration of Registration of Medical Devices and the Measures for the Administration of Registration of In Vitro Diagnostic Reagents, , “Medical Device Manual and Label Management Regulations”, “Medical Device Production Supervision and Management Measures”, “Medical Device Operation Supervision and Management Measures” and other five rules. And with the State Food and Drug Administration Order No. 4,5,6,7,8 announced on October 1, 2014 will be implemented. The newly revised and revised five sections implement the Party Central Committee and the State Council’s policy of establishing the most stringent food and drug regulatory system covering the entire process, accelerating the transformation of government functions and deepening the reform of the administrative examination and approval system, adhering to the principles of risk management, full treatment, social governance, responsibility Governance, efficiency management and other management