【中英文对照版】国家药监局关于进一步加强医疗器械注册人委托生产监督管理的公告.docx

国家药监局关于进一步加强医疗器械注册人委托生产监督管理的公告（国家药监局公告2024年第38号）为贯彻实施医疗器械监督管理条例，全面落实医疗器械注册人（以下简称注册人）质量安全主体责任，进一步加强注册人委托生产监督管理，有效防控医疗器械质量安全风险。现就有关事宜公告如下：国家药监局关于进一步加强医疗器械注册人委托生产监督管理的公告AnnouncementoftheNationalMedicalProductsAdministrationonFurtherStrengtheningSupervisionandAdministrationofEntrustedProductionbyMedicalDeviceRegistrants制定机关：国家药品监督管理局(已变更)发文字号：国家药监局公告2024年第38号公布日期：2024.04.02施行日期：2024.06.01效力位阶：部门规范性文件法规类别：卫生综合规定IssuingAuthority：StaleDrugSupervision&AdministrationBureau(replaced)DocumentNumber：AnnouncementNo.382024oftheNationalMedicalProductsAdministrationDateIssued：04-02-2024EffectiveDate：06-01-20241.evelofAuthority：DepartmentalRegulatoryDocumentsAreaof1.aW:GeneralProvisionsonHealthandSanitationAnnouncementoftheNationalMedicalProductsAdministrationonFurtherStrengtheningSupervisionandAdministrationofEntrustedProductionbyMedicalDeviceRegistrants(AnnouncementNo.382024oftheNationalMedicalProductsAdministration)ForthepurposesofimplementingtheRegulationontheSupervisionandAdministrationofMedicalDevices,fullyimplementingtheprimaryresponsibilityofmedicaldeviceregistrants(hereinafterreferredtoas“registrants")forqualityandsafety,furtherstrengtheningthesupervisionandadministrationofentrustedproductionbyregistrants,andeffectivelypreventingandcontrollingthequalityandsafetyrisksofmedicaldevices,relevantmattersareherebyannouncedasfollows:I.Strictlyimplementingtheprimaryresponsibilityofmedicaldeviceregistrants1. Aregistrantshallfullyimplementtheprimaryresponsibilityforthequalityandsafetyofmedicaldevices,establishaqualitymanagementsystemcoveringthewholelifecycleofmedicaldevicesandmaintaineffectiveoperation.Aregistrantentrustingproductionshallestablishandimproveamanagementinstitutionthatiscompatiblewiththecharacteristicsoftheproductswhoseproductionisentrustedandtheenterprisescale,fullyperformfunctionssuchasproductriskmanagement,changecontrol,productrelease,after-salesservice,handlingofproductcomplaints,adverseeventmonitoringandproductrecall,andreviewtheoperationofthequalitymanagementsystemoftheentrustedmanufacturerinaccordancewiththequalitymanagementspecificationsforproductionofmedicaldevices.一、严格落实医疗器械注册人主体责任（一）注册人应当全面落实医疗器械质量安全主体责任，建立覆盖医疗器械全生命周期的质量管理体系并保持有效运行。注册人委托生产的，应当建立健全与所委托生产的产品特点、企业规模相适应的管理机构，充分履行产品风险管理、变更控制、产品放行、售后服务、产品投诉处理、不良事件监测和产品召回等职责，定期按照医疗器械生产质量管理规范对受托生产企业质量管理体系运行情况进行审核。注册人仅委托生产时，也应当保持产品全生命周期质量管理能力，维持质量管理体系完整性和有效性；设置与委托生产相适应的管理机构，并至少明确技术、生产、质量管理、不良事件监测、售后服务等相关部门职责，质量管理部门应当独立设置，配备足够数量和能力的专职质量管理人员，以及熟悉产品、具有相应专业知识的技术人员，能够对委托生产活动进行有效的监测和Whenaregistrantonlyentrustsproduction,itshallalsomaintainthequalitymanagementabilityoftheproductthroughoutthelifecycleandmaintaintheintegrityandeffectivenessofthequalitymanagementsystem;setupamanagementinstitutionsuitablefortheentrustedproduction,andspecifytheresponsibilitiesofrelevantdepartmentssuchastechnology,production,qualitymanagement,adverseeventmonitoring,andaftersalesservice.Thequalitymanagementdepartmentshallbesetupindependently,appointasufficientnumberofcapablefull-timequalitymanagementpersonnelandtechnicalpersonnelfamiliarwiththeproductsandwithcorrespondingprofessionalknowledge,andbeabletoeffectivelymonitorandcontrolentrustedproductionactivities.控制。注册人应当能够依法承担医疗器械质量安全责任，鼓励通过购买商业保险等形式，建立与产品风险程度、市场规模和人身损害赔偿标准等因素相匹配的责任赔偿能力。（二）注册人应当优先选择质量管理水平较高、生产规模较大、信用记录良好、生产自动化程度和信息化管理水平较高的企业作为受托方。进行委托生产前，注册人应当要求受托方提交信用情况说明，并查阅监管部门公开信息，全面了解受托方信用情况。（三）对于植入性医疗器械，鼓励注册人自行生产，确需进行委托生产的，在委托生产活动期间，注册人原则上应当选派具有相关领域生产质量管理工作经验、熟悉产品生产过程和质量控制要求的人员入驻受托生产企业，对生产管理、质量管理关键环节进行现场指导和监督，确保按照法规、规章、规范性文件、强制性标准和经注册的产品技术要求组织生产。派驻人员工作职责应当在质量协议中予以Aregistrantshallbeabletoassumetheresponsibilityforthequalityandsafetyofmedicaldevicesinaccordancewiththelaw,andencouragetheestablishmentofliabilitycompensationcapabilitiesmatchingfactorssuchasthedegreeofproductrisk,marketsizeandpersonalinjurycompensationstandardsthroughpurchaseofcommercialinsurance.2. Aregistrantshallpreferentiallyselectenterpriseswithrelativelyhighqualitymanagementlevel,relativelylargeproductionscale,goodcreditrecord,andrelativelyhighproductionautomationlevelandinformationmanagementlevelasthetrustee.Beforeentrustingproduction,aregistrantshallrequireatrusteetosubmitastatementofcreditstatus,andconsultthepublicinformationontheregulatorydepartmenttofullyunderstandthecreditstatusofthetrustee.3. Wherearegistrantisencouragedtoproduceimplantablemedicaldevicesbythemselvesandentrustedproductionisreallynecessary,duringtheperiodofentrustedproductionactivities,aregistrantshall,inprinciple,selectpersonnelwithproductionqualitymanagementexperienceinrelevantfieldsandfamiliarwithproductproductionprocessandqualitycontrolrequirementstosettleintheentrustedmanufacturer,andprovideon-siteguidanceforandimplementsupervisionoverkeylinksofproductionmanagementandqualitymanagementtoensurethatproductionisorganizedaccordingtolaws,regulations,normativedocuments,mandatorystandardsandtechnicalrequirementsforregisteredproducts.Thejobresponsibilitiesofpersonnelappointedshallbeclearlyspecifiedinthequalityagreeme