2019年一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)报告(gao)(gao)一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)报告(gao)(gao)是(shi)报告(gao)(gao)大厅(ting)在对(dui)(dui)要(yao)(yao)从事(shi)一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)行(xing)(xing)业(ye)或(huo)(huo)者(zhe)(zhe)要(yao)(yao)进入投资(zi)之前，对(dui)(dui)一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)行(xing)(xing)业(ye)的(de)(de)(de)(de)相关(guan)因素以(yi)及(ji)(ji)具体的(de)(de)(de)(de)行(xing)(xing)情(qing)(qing)进行(xing)(xing)具体研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)、分(fen)析(xi)(xi)、调(diao)查以(yi)及(ji)(ji)评估项(xiang)(xiang)目的(de)(de)(de)(de)可行(xing)(xing)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)、效果(guo)(guo)效益等(deng)，从而提出建设性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)意见以(yi)及(ji)(ji)建议对(dui)(dui)策。为一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)行(xing)(xing)业(ye)投资(zi)决策者(zhe)(zhe)或(huo)(huo)者(zhe)(zhe)是(shi)主管总结下研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)报告(gao)(gao)！ 一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)报告(gao)(gao)主要(yao)(yao)是(shi)对(dui)(dui)分(fen)析(xi)(xi)一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)行(xing)(xing)业(ye)需求、供(gong)给、经营特(te)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)、获(huo)(huo)取能力(li)、产业(ye)链(lian)和价(jia)值(zhi)链(lian)等(deng)多方面的(de)(de)(de)(de)内(nei)容，整合行(xing)(xing)业(ye)、市场、企业(ye)、用(yong)(yong)户等(deng)多层面数据和信息资(zi)源，为客(ke)户提供(gong)深(shen)度(du)的(de)(de)(de)(de)一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)行(xing)(xing)业(ye)市场研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)报告(gao)(gao)，以(yi)专业(ye)的(de)(de)(de)(de)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)方法(fa)帮助客(ke)户深(shen)入的(de)(de)(de)(de)了(le)解(jie)一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)行(xing)(xing)业(ye)情(qing)(qing)况，发现投资(zi)价(jia)值(zhi)和投资(zi)机(ji)会，规避(bi)(bi)经营风险，提高管理(li)(li)和运营能力(li)。一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)报告(gao)(gao)必须对(dui)(dui)一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)行(xing)(xing)业(ye)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)内(nei)容和方法(fa)进行(xing)(xing)全面的(de)(de)(de)(de)阐述和论(lun)证，对(dui)(dui)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)过(guo)程(cheng)中所(suo)获(huo)(huo)取的(de)(de)(de)(de)一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)资(zi)料(liao)进行(xing)(xing)全面系(xi)统(tong)(tong)的(de)(de)(de)(de)整理(li)(li)和分(fen)析(xi)(xi)，通过(guo)图表、统(tong)(tong)计结果(guo)(guo)及(ji)(ji)文献资(zi)料(liao)，或(huo)(huo)以(yi)纵(zong)向的(de)(de)(de)(de)发展过(guo)程(cheng)，或(huo)(huo)横向类(lei)别分(fen)析(xi)(xi)提出论(lun)点、分(fen)析(xi)(xi)论(lun)据，进行(xing)(xing)论(lun)证。一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)报告(gao)(gao)分(fen)：一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)对(dui)(dui)象(xiang)和方法(fa) 、研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)内(nei)容和假(jia)设 、研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)步骤及(ji)(ji)过(guo)程(cheng)以(yi)及(ji)(ji)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)结果(guo)(guo)的(de)(de)(de)(de)分(fen)析(xi)(xi)与讨论(lun)。一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)报告(gao)(gao)内(nei)容的(de)(de)(de)(de)逻辑(ji)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)是(shi)整个研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)思路(lu)逻辑(ji)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)的(de)(de)(de)(de)写(xie)照，没有一(yi)个好的(de)(de)(de)(de)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)基础以(yi)及(ji)(ji)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)渠道方法(fa)，是(shi)写(xie)不出一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)科研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)报告(gao)(gao)。对(dui)(dui)于一(yi)次(ci)(ci)(ci)(ci)性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)使(shi)(shi)用(yong)(yong)口(kou)(kou)(kou)(kou)(kou)腔(qiang)(qiang)(qiang)护(hu)(hu)(hu)理(li)(li)包(bao)研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)报告(gao)(gao)内(nei)容报告(gao)(gao)大厅(ting)相对(dui)(dui)如实地反(fan)映客(ke)观情(qing)(qing)况，一(yi)切叙(xu)述、说明、推(tui)断、引用(yong)(yong)，恰如其分(fen)。文字、用(yong)(yong)词应力(li)求准(zhun)确(que)。概念表述用(yong)(yong)科学性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)用(yong)(yong)语，避(bi)(bi)免用(yong)(yong)常识性(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)(xing)用(yong)(yong)语，以(yi)免读者(zhe)(zhe)费(fei)解(jie)或(huo)(huo)产生(sheng)歧义。当然，研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)报告(gao)(gao)的(de)(de)(de)(de)文字我(wo)们也努(nu)力(li)做到简(jian)单、明了(le)、通顺(shun)、流畅，既要(yao)(yao)明白(bai)如话(hua)，又要(yao)(yao)把研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)的(de)(de)(de)(de)效果(guo)(guo)准(zhun)确(que)地、科学地表达出来。通过(guo)全面的(de)(de)(de)(de)调(diao)查研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)以(yi)及(ji)(ji)分(fen)析(xi)(xi)论(lun)证某个建设或(huo)(huo)改造工(gong)程(cheng)。某种(zhong)科学研(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)(yan)究(jiu)(jiu)(jiu)、某项(xiang)(xiang)商(shang)务活动切实可行(xing)(xing)而提出的(de)(de)(de)(de)一(yi)种(zhong)书面材(cai)料(liao)。

疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理法(fa)草(cao)案(an)23日(ri)首次(ci)(ci)提(ti)(ti)请十三届人大常委(wei)会(hui)第七次(ci)(ci)会(hui)议审(shen)议。草(cao)案(an)就疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理单(dan)独立(li)法(fa)，突出疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理特点，强化疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)的(de)风险(xian)管(guan)(guan)理、全(quan)程控(kong)制、严格监(jian)管(guan)(guan)和社会(hui)共治，切实疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)安全(quan)、有效和规(gui)范接(jie)种(zhong)。党中央(yang)、国(guo)务院高度(du)重视疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)监(jian)管(guan)(guan)工作(zuo)，要求加快完善疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)药品监(jian)管(guan)(guan)长效机(ji)制。疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理单(dan)独立(li)法(fa)，有利于(yu)进一步提(ti)(ti)高疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理措施的(de)稳定(ding)性。药监(jian)局政策法(fa)规(gui)司有关负责(ze)人介绍，2005年国(guo)务院出台(tai)了(le)《疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)流通(tong)和预防接(jie)种(zhong)管(guan)(guan)理条例》，并于(yu)2016年进行了(le)修订。此次(ci)(ci)提(ti)(ti)交审(shen)议的(de)疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理法(fa)草(cao)案(an)，对疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)研制、生(sheng)产、流通(tong)、预防接(jie)种(zhong)、补(bu)偿、赔(pei)偿等以法(fa)律形式进行明(ming)确(que)规(gui)定(ding)，有利于(yu)建立(li)系统的(de)、全(quan)链条的(de)疫(yi)(yi)(yi)(yi)苗(miao)(miao)(miao)(miao)管(guan)(guan)理制度(du)。

局(ju)(ju)机关各(ge)(ge)司局(ju)(ju)、各(ge)(ge)直属(shu)单位(wei)：为加强(qiang)对(dui)药品(pin)监(jian)管政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)工(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)的(de)领(ling)导，局(ju)(ju)党(dang)(dang)组(zu)会议研(yan)究决定成(cheng)(cheng)立药品(pin)监(jian)督管理局(ju)(ju)政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)领(ling)导小组(zu)，下设办公(gong)室（以下简称政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)办）。现将(jiang)有关事(shi)项通知如(ru)下：一、政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)领(ling)导小组(zu)组(zu)成(cheng)(cheng)及职责（一）组(zu)成(cheng)(cheng)组(zu)长：李利焦红副组(zu)长：徐景和(he)陈时飞颜(yan)江(jiang)(jiang)瑛成(cheng)(cheng)员：各(ge)(ge)司局(ju)(ju)、各(ge)(ge)直属(shu)单位(wei)主(zhu)要负责同志(zhi)颜(yan)江(jiang)(jiang)瑛同志(zhi)负责领(ling)导小组(zu)日常工(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)。（二）主(zhu)要职责。在局(ju)(ju)党(dang)(dang)组(zu)领(ling)导下，负责贯彻(che)落实党(dang)(dang)中央、国务(wu)(wu)(wu)院关于政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)工(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)的(de)方(fang)(fang)针政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)策(ce)，研(yan)究制(zhi)定落实措(cuo)施；研(yan)究制(zhi)定药品(pin)监(jian)管政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)工(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)的(de)发(fa)展规划和(he)政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)策(ce)措(cuo)施；审定局(ju)(ju)政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)工(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)制(zhi)度(du)，研(yan)究局(ju)(ju)政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)工(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)和(he)实施方(fang)(fang)案，研(yan)究解决政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)工(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)中遇到(dao)的(de)重大(da)问题；协(xie)调各(ge)(ge)司局(ju)(ju)、各(ge)(ge)单位(wei)抓好政(zheng)(zheng)(zheng)(zheng)(zheng)(zheng)务(wu)(wu)(wu)公(gong)开(kai)(kai)工(gong)(gong)(gong)(gong)作(zuo)(zuo)(zuo)任务(wu)(wu)(wu)落实，并加强(qiang)督促检查。

医疗器械标准是医疗器械研制、生产、经营、使用以及监督管理所共同遵循的技术规范，是医疗器械监管和产业发展的重要技术支撑。医用一次性使用吸痰包药监局高度重视医疗器械标准工作，按照“四个严”的要求，结合医疗器械产业发展和监管工作实际，不断完善医疗器械标准管理制度体系、持续开展医疗器械标准制修订工作，我国医疗器械标准体系不断完善，医疗器械标准对监管和产业发展的技术支撑能力持续提升。一、加强医疗器械标准制度建设。一次性使用吸痰包批发为贯(guan)彻落(luo)(luo)实(shi)(shi)国(guo)务院深化标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)化改革重大决策部署，依据《中华人民共和(he)国(guo)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)化法》，立(li)足我国(guo)医(yi)(yi)疗(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)产业发(fa)展和(he)监(jian)管(guan)(guan)(guan)工(gong)(gong)作实(shi)(shi)际，2017年4月，原(yuan)食(shi)品药品监(jian)管(guan)(guan)(guan)总局(ju)修(xiu)订(ding)印发(fa)《医(yi)(yi)疗(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)管(guan)(guan)(guan)理办法》，该办法的出(chu)台(tai)对(dui)指导我国(guo)医(yi)(yi)疗(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)管(guan)(guan)(guan)理、规范标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)制(zhi)修(xiu)订(ding)、促进标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)实(shi)(shi)施、提升医(yi)(yi)疗(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)质量等起到了积极作用(yong)。为贯(guan)彻落(luo)(luo)实(shi)(shi)《医(yi)(yi)疗(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)管(guan)(guan)(guan)理办法》，原(yuan)食(shi)品药品监(jian)管(guan)(guan)(guan)总局(ju)先后(hou)印发(fa)《医(yi)(yi)疗(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)制(zhi)修(xiu)订(ding)工(gong)(gong)作管(guan)(guan)(guan)理规范》和(he)《医(yi)(yi)疗(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)报批(pi)发(fa)布(bu)工(gong)(gong)作细(xi)则》等文件，进一步规范了医(yi)(yi)疗(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)工(gong)(gong)作程(cheng)序，强(qiang)化了标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)精细(xi)化过程(cheng)管(guan)(guan)(guan)理，为提升医(yi)(yi)疗(liao)(liao)器(qi)(qi)械(xie)(xie)(xie)标(biao)(biao)(biao)准(zhun)(zhun)(zhun)(zhun)质量奠(dian)定(ding)了坚实(shi)(shi)的制(zhi)度基(ji)础。