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为加强医疗器械生产监督管理,规范医疗器械生产质量管理,进一步保障公众用械安全有效,根据新发布的《医疗器械监督管理条例》和《医疗器械生产监督管理办法》,国家食品药品监督管理总局组织对《医疗器械生产质量管理规范(试行)》进行了修订,修订后的《医疗器械生产质量管理规范》(以下简称《规范》)自2015年3
In order to strengthen the supervision and administration of medical device production, standardize the quality management of medical device production and further ensure the safety and effectiveness of public use of the device, according to the newly promulgated Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Production, the State Food and Drug Administration The organization revised the “Medical Device Manufacturing Quality Management Standard (Trial)”, and the revised “Medical Device Manufacturing Quality Management Specification” (hereinafter referred to as “the”) since 2015 3