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最近新修订的《医疗器械监督管理条例》(国务院令第650号)(以下简称新《条例》)已于2014年6月1日起施行,新《条例》大幅增加了对违法行为的行政处罚力度、彻底放开了对于二类医疗器械的经营许可权,同时也增加了有关医疗器械使用单位转让医疗器械的相关规定,即第四十一条“医疗器械使用单位之间转让在用医疗器械,转让方应当确保所转让的医疗器械安全、有效,不得转让过期、失效、淘汰以及检验不
The newly revised ”Medical Device Supervision and Management Regulations“ (State Council Decree No. 650) (hereinafter referred to as the ”new“ Ordinance) came into effect on June 1, 2014, and the new ”Regulations“ have significantly increased the administrative penalties for unlawful acts Efforts to completely open up the business license for the second category of medical devices, but also increased the relevant provisions on the transfer of medical devices used by medical device units, the forty-first ”transfer of medical devices between the use of medical Instruments, the transferor shall ensure that the transfer of medical equipment is safe and effective, may not transfer expired, invalidated, eliminated and the test is not