推进(jin)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)质(zhi)(zhi)量管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)规(gui)(gui)范实施(shi)(shi)，加(jia)强(qiang)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)监(jian)(jian)督(du)管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)，指(zhi)(zhi)导(dao)(dao)监(jian)(jian)管(guan)(guan)(guan)(guan)部门对(dui)(dui)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)企(qi)业实施(shi)(shi)《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)质(zhi)(zhi)量管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)规(gui)(gui)范》及(ji)其(qi)相关(guan)附(fu)录(lu)的现(xian)(xian)场(chang)(chang)检(jian)(jian)(jian)(jian)查(cha)和对(dui)(dui)检(jian)(jian)(jian)(jian)查(cha)结果的评(ping)估，根据《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)质(zhi)(zhi)量管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)规(gui)(gui)范》及(ji)其(qi)相关(guan)附(fu)录(lu)，国家(jia)食品药品监(jian)(jian)督(du)管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)总(zong)局组织(zhi)制定了《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)质(zhi)(zhi)量管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)规(gui)(gui)范现(xian)(xian)场(chang)(chang)检(jian)(jian)(jian)(jian)查(cha)指(zhi)(zhi)导(dao)(dao)原(yuan)则》《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)质(zhi)(zhi)量管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)规(gui)(gui)范无菌医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)现(xian)(xian)场(chang)(chang)检(jian)(jian)(jian)(jian)查(cha)指(zhi)(zhi)导(dao)(dao)原(yuan)则》《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)质(zhi)(zhi)量管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)规(gui)(gui)范植(zhi)入(ru)性医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)现(xian)(xian)场(chang)(chang)检(jian)(jian)(jian)(jian)查(cha)指(zhi)(zhi)导(dao)(dao)原(yuan)则》《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)质(zhi)(zhi)量管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)规(gui)(gui)范体(ti)外诊断(duan)试剂现(xian)(xian)场(chang)(chang)检(jian)(jian)(jian)(jian)查(cha)指(zhi)(zhi)导(dao)(dao)原(yuan)则》。指(zhi)(zhi)导(dao)(dao)原(yuan)则用(yong)于指(zhi)(zhi)导(dao)(dao)监(jian)(jian)管(guan)(guan)(guan)(guan)部门对(dui)(dui)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)企(qi)业实施(shi)(shi)《医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)质(zhi)(zhi)量管(guan)(guan)(guan)(guan)理(li)(li)(li)(li)(li)规(gui)(gui)范》及(ji)相关(guan)附(fu)录(lu)的现(xian)(xian)场(chang)(chang)检(jian)(jian)(jian)(jian)查(cha)和对(dui)(dui)检(jian)(jian)(jian)(jian)查(cha)结果的评(ping)估，适(shi)用(yong)于医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)注册现(xian)(xian)场(chang)(chang)核查(cha)、医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)许可（含延续或变更）现(xian)(xian)场(chang)(chang)检(jian)(jian)(jian)(jian)查(cha)，以及(ji)根据工作需要对(dui)(dui)医(yi)(yi)(yi)(yi)疗(liao)(liao)(liao)(liao)(liao)器(qi)(qi)(qi)械(xie)(xie)(xie)(xie)生(sheng)产(chan)(chan)企(qi)业开展的各类监(jian)(jian)督(du)检(jian)(jian)(jian)(jian)查(cha)。

随着《医疗器械生产质量管理规范》和相应检查指导原则的陆续出台，标志着一个以《医疗器械监督管理条例》为核心，医疗器械生产监督管理办法、国家重点监管医疗器械目录、禁止委托生产医疗器械目录、医疗器械生产企业分类分级管理规定等法规规章为基础，《规范》、规范检查指导原则，无菌、植入性医疗器械、体外诊断试剂规范附录及检查指导原则等规范性文件为手段，其他相应生产企业供应商审核指南、制水环节指南等指南性文件为补充的医疗器械生产环节监管的法规制度体系已形成并在不断完善中。