本刊讯新修订的《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(简称“总局”)制订、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 Our new revised “Medical Device Supervision and Management Ordinance” (hereinafter referred to as “Ordinance”) on June 1, 2014 shall come into effect. 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 (hereinafter referred to as “the General Administration of Administration”) formulated and revised the “Measures for the Administration of Medical Device Registration” “Measures for the Administration of In Vitro Diagnostic Reagents”, “Medical Device Manuals and Labeling Regulations”, “Measures for the Supervision and Administration of Medical Device Manufacturing”, "Medical Device Business