医疗器械注册质量体系核查

培养学生独立工作能力的重要步骤，是实现培养目标要求的重要阶段，是对学生综合素质与工程实践能力培养效果的全面检验，是学生毕业资格认定的重要依据。toacustomerrequestforobjective,comprehensiveinvestigation,analysis,evaluation,focusingonfactorsthatcouldaffectcreditassets,effectiveidentificationofrisks.EighthinvestigatorsshouldbebasedontheBank'screditpolicyscreening,filterinlinewiththeBank'screditscopeofcustomer,creditbusiness,shallnotentertainourprohibitionofinvolvementofclientsandcreditbusiness.Ninethsurveyaboutcustomersurveysanddataverificationshouldbebasedonfieldsurveys,andindirectsurveysasasupplement.Ifnecessary,byexternalcreditBureautoverifytheauthenticityofcustomerinformation.Articletenthcreditpre-loaninvestigationshouldbecompletedbythepersonhimself,maynotauthorizeathirdparty,exceptwhereotherwiseprovidedforbythesystemoftheBank.BranchManagermayhint,instruction,ordersignatureofinvestigationsincasesthatarenotinvolvedintheinvestigation,pre-loaninvestigationamereformality.11thpre-loaninvestigationshouldbetwoparticipants,oneperson,anotherpersonaidedperson,exceptonbusinesswithspecialprovisions.Mainandauxiliaryofficersshallbeduediligence,investigatorsasasponsorofthecreditbusiness,bearprimaryresponsibilityforcredit,istheresponsibilityofcreditbusiness.Riskmanagersparticipateinthepre-loaninvestigationworkinparallel,asadoubleinvestigation,riskmanagersheldaccountablefortheirfindings.Article12thpre-loaninvestigationofficershallgivetheiropinioninacreditreportandsignatures,findingsshouldbeclear.Onlysignedcomments,andambiguousorcontradictory,deemedtobeagreedforthecreditbusiness.13thmarketinglinesmanagementdepartmentsatalllevelstomeettheconditionsofcredit1境内医疗器械注册质量管理体系核查操作规范（征求意见稿）第一条为规范医疗器械注册质量管理体系核查工作，根据《医疗器械注册管理办法》（国家食品药品监督管理总局令第4号）和《体外诊断试剂注册管理办法》（国家食品药品监督管理总局令第5号）的相关规定，制定本操作规范。第二条本操作规范适用于境内第二类、第三类医疗器械注册质量管理体系核查。第三条食品药品监督管理部门组织对申请人进行与产品研制、生产有关的质量管理体系核查。境内第三类医疗器械注册质量管理体系核查，由国家食品药品监督管理总局（以下简称“总局”）技术审评机构通知相应省、自治区、直辖市食品药品监督管理部门开展核查，必要时参与核查。省、自治区、直辖市食品药品监督管理部门负责组织开展核查。第四条境内第三类医疗器械注册质量管理体系核查，由总局技术审评机构向相应省、自治区、直辖市食品药品监督管理部门发出通知。省、自治区、直辖市食品药品监督管理部门应当在收到通知之日起5个工作日内告知注册申请人。第五条注册申请人应当向省、自治区、直辖市食品药品监督管理部门出具医疗器械质量管理体系核查承诺书，承诺可随培养学生独立工作能力的重要步骤，是实现培养目标要求的重要阶段，是对学生综合素质与工程实践能力培养效果的全面检验，是学生毕业资格认定的重要依据。toacustomerrequestforobjective,comprehensiveinvestigation,analysis,evaluation,focusingonfactorsthatcouldaffectcreditassets,effectiveidentificationofrisks.EighthinvestigatorsshouldbebasedontheBank'screditpolicyscreening,filterinlinewiththeBank'screditscopeofcustomer,creditbusiness,shallnotentertainourprohibitionofinvolvementofclientsandcreditbusiness.Ninethsurveyaboutcustomersurveysanddataverificationshouldbebasedonfieldsurveys,andindirectsurveysasasupplement.Ifnecessary,byexternalcreditBureautoverifytheauthenticityofcustomerinformation.Articletenthcreditpre-loaninvestigationshouldbecompletedbythepersonhimself,maynotauthorizeathirdparty,exceptwhereotherwiseprovidedforbythesystemoftheBank.BranchManagermayhint,instruction,ordersignatureofinvestigationsincasesthatarenotinvolvedintheinvestigation,pre-loaninvestigationamereformality.11thpre-loaninvestigationshouldbetwoparticipants,oneperson,anotherpersonaidedperson,exceptonbusinesswithspecialprovisions.Mainandauxiliaryofficersshallbeduediligence,investigatorsasasponsorofthecreditbusiness,bearprimaryresponsibilityforcredit,istheresponsibilityofcreditbusiness.Riskmanagersparticipateinthepre-loaninvestigationworkinparallel,asadoubleinvestigation,riskmanagersheldaccountablefortheirfindings.Article12thpre-loaninvestigationofficershallgivetheiropinioninacreditreportandsignatures,findingsshouldbeclear.Onlysignedcomments,andambiguousorcontradictory,deemedtobeagreedforthecreditbusiness.13thmarketinglinesmanagementdepartmentsatalllevelstomeettheconditionsofcredit—2—时接受现场检查。注册申请人不能在省、自治区、直辖市食品药品监督管理部门安排的时间内接受现场检查的，省、自治区、直辖市食品药品监督管理部门将情况告知总局医疗器械技术审评机构，总局医疗器械技术审评机构终止技术审评，食品药品监督管理部门作出不予注册的决定。第六条注册申请人应当按照本操作规范的要求（见附件1）向省、自治区、直辖市食品药品监督管理部门提交相关资料。注册申请人对所提交资料内容的真实性负责。第七条省、自治区、直辖市食品药品监督管理部门对注册申请人提交的注册质量管理体系核查资料进行形式审查。符合要求的，应当在10个工作日内完成审查；不符合要求的，应当一次性要求注册申请人进行补充。注册申请人未在1个月内提交补充材料的，终止审查。体系核查终止审查的，省、自治区、直辖市食品药品监督管理部门将情况告知总局医疗器械技术审评机构，总局医疗器械技术审评机构终止技术审评，食品药品监督管理部门作出不予注册的决定。第八条省、自治区、直辖市食品药品监督管理部门经审查，确认注册质量管理体系核查资料符合要求后，应当在20个工作日内完成质量管理体系核查工作。省、自治区、直辖市食品药品监督管理部门应当在开展现场检查前5个工作日通知总局技术审评机构和注册申请人。第九条省、自治区、直辖市食品药品监督管理部门按照质量管理体系相关要求开展现场检查。体外诊断试剂产品按照培养学生独立工作能力的重要步骤，是实现培养目标要求的重要阶段，是对学生综合素质与工程实践能力培养效果的全面检验，是学生毕业资格认定的重要依据。toacustomerrequestforobjective,comprehensiveinvestigation,analysis,evaluation,focusingonfactorsthatcouldaffectcreditassets,effectiveidentificationofrisks.EighthinvestigatorsshouldbebasedontheBank'screditpolicyscreening,filterinlinewiththeBank'screditscopeofcustomer,creditbusiness,shallnotentertainourprohibitionofinvolvementofclientsandcreditbusiness.Ninethsurveyaboutcustomersurveysanddataverificationshouldbebasedonfieldsurveys,andindirectsurveysasasupplement.Ifnecessary,byexternalcreditBureautoverifytheauthenticityofcustomerinformation.Articletenthcreditpre-loaninvestigationshouldbecompletedbythepersonhimself,maynotauthorizeathirdparty,exceptwhereotherwiseprovidedforbythesystemoftheBa