《【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》由会员分享，可在线阅读，更多相关《【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（18页珍藏版）》请在三一办公上搜索。
1、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AnnouncementoftheNationalMedicalProductsAdministrationonFurtherStrengtheningSupervisionandAdministrationofEntrustedProductionbyMedical
2、DeviceRegistrants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：06-01-202
3、41.evelofAuthority：DepartmentalRegulatoryDocumentsAreaof1.aW:GeneralProvisionsonHealthandSanitationAnnouncementoftheNationalMedicalProductsAdministrationonFurtherStrengtheningSupervisionandAdministrationofEntrustedProductionbyMedicalDeviceRegistrants(AnnouncementNo.382024oftheNationalMedicalProducts
4、Administration)ForthepurposesofimplementingtheRegulationontheSupervisionandAdministrationofMedicalDevices,fullyimplementingtheprimaryresponsibilityofmedicaldeviceregistrants(hereinafterreferredtoas“registrants)forqualityandsafety,furtherstrengtheningthesupervisionandadministrationofentrustedproducti
5、onbyregistrants,andeffectivelypreventingandcontrollingthequalityandsafetyrisksofmedicaldevices,relevantmattersareherebyannouncedasfollows:I.Strictlyimplementingtheprimaryresponsibilityofmedicaldeviceregistrants1. Aregistrantshallfullyimplementtheprimaryresponsibilityforthequalityandsafetyofmedicalde
6、vices,establishaqualitymanagementsystemcoveringthewholelifecycleofmedicaldevicesandmaintaineffectiveoperation.Aregistrantentrustingproductionshallestablishandimproveamanagementinstitutionthatiscompatiblewiththecharacteristicsoftheproductswhoseproductionisentrustedandtheenterprisescale,fullyperformfu
7、nctionssuchasproductriskmanagement,changecontrol,productrelease,after-salesservice,handlingofproductcomplaints,adverseeventmonitoringandproductrecall,andreviewtheoperationofthequalitymanagementsystemoftheentrustedmanufacturerinaccordancewiththequalitymanagementspecificationsforproductionofmedicaldev
8、ices.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
9、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;setupamanagementinstitutionsuitablefortheentrus
10、tedproduction,andspecifytheresponsibilitiesofrelevantdepartmentssuchastechnology,production,qualitymanagement,adverseeventmonitoring,andaftersalesservice.Thequalitymanagementdepartmentshallbesetupindependently,appointasufficientnumberofcapablefull-timequalitymanagementpersonnelandtechnicalpersonnelf
11、amiliarwiththeproductsandwithcorrespondingprofessionalknowledge,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
12、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Aregistrantshallbeabletoassumetheresponsibilityforthequalityandsafetyofmedicaldevicesinaccordancewithth
13、elaw,andencouragetheestablishmentofliabilitycompensationcapabilitiesmatchingfactorssuchasthedegreeofproductrisk,marketsizeandpersonalinjurycompensationstandardsthroughpurchaseofcommercialinsurance.2. Aregistrantshallpreferentiallyselectenterpriseswithrelativelyhighqualitymanagementlevel,relativelyla
14、rgeproductionscale,goodcreditrecord,andrelativelyhighproductionautomationlevelandinformationmanagementlevelasthetrustee.Beforeentrustingproduction,aregistrantshallrequireatrusteetosubmitastatementofcreditstatus,andconsultthepublicinformationontheregulatorydepartmenttofullyunderstandthecreditstatusof
15、thetrustee.3. Wherearegistrantisencouragedtoproduceimplantablemedicaldevicesbythemselvesandentrustedproductionisreallynecessary,duringtheperiodofentrustedproductionactivities,aregistrantshall,inprinciple,selectpersonnelwithproductionqualitymanagementexperienceinrelevantfieldsandfamiliarwithproductpr
16、oductionprocessandqualitycontrolrequirementstosettleintheentrustedmanufacturer,andprovideon-siteguidanceforandimplementsupervisionoverkeylinksofproductionmanagementandqualitymanagementtoensurethatproductionisorganizedaccordingtolaws,regulations,normativedocuments,mandatorystandardsandtechnicalrequir
17、ementsforregisteredproducts.Thejobresponsibilitiesofpersonnelappointedshallbeclearlyspecifiedinthequalityagreement.Theproductsinthe1.istofMedicalDevicesProhibitedfromBeingProduceduponEntrustmentshallnotbeproduceduponentrustment.明确。禁止委托生产医疗器械目录中的产品不得委托生产。4. Aregistrantentrustingproductionshallenterin
18、toaqualityagreementwiththeentrustedmanufacturerinaccordancewiththerequirementsoftheGuidelinesforthePreparationofQualityAgreementforEntrustedProductionofMedicalDevicesandinlightoftheactualcircumstancesoftheenterprise.Inprinciple,thevalidityperiodofaqualityagreementshallnotexceedthevalidityperiodofthe
19、productregistrationcertificateandtheproductionlicenseoftheentrustedmanufacturer.Underthepremiseofsatisfyingtherequirementsofrelevantlawsandregulations,aregistrantmayagreewiththeentrustedmanufacturerinthequalityagreementonthespecificimplementationmethodofdocumentcontrol,procurementcontrol,processcont
20、rol,inspectioncontrol,productrelease,changecontrol,etc.,butmustclearlyconductcommunicationandconnectionwiththerequirements.5. Aregistrantshall,inconjunctionwiththeentrustedmanufacturer,converttherelevantrequirementsofthequalityagreementintothemanagementdocumentsrelatedtoexecutableentrustedproduction
21、,andsupervisetheimplementationoftheentrustedmanufacturer.Enterprisesshallbeencouragedtousecontrolledinformationsystemstooptimizemanagementprocessesrelatedtoentrustedproductionandimprovethequalitymanagementefficiency.（四）注册人进行委托生产，应当按照医疗器械委托生产质量协议编制指南要求，结合企业实际情况，与受托生产企业签订质量协议，原则上质量协议有效期限不超过产品注册证和受托生产企
22、业生产许可证有效期限。在符合相关法规要求的前提下，注册人可以与受托生产企业在质量协议中自行约定文件控制、采购控制、过程控制、检验控制、产品放行、变更控制等的具体实施方式，但必须明确沟通和衔接要求。（五）注册人应当会同受托生产企业，将质量协议相关要求转化为可执行的委托生产相关管理文件，并监督受托生产企业落实到位。鼓励企业采用受控的信息化系统优化委托生产相关管理流程，提升质量管理效能。注册人和受托生产企业应当每年对质量协议的适宜性、充分性、有效性开展评审，确认质量协议相关要求与委Aregistrantandanentrustedmanufacturershallannuallyreviewthes
23、uitability,adequacyandeffectivenessofthequalityagreementandconfirmthattherelevantrequirementsofthequalityagreementareconsistentwiththeentrustedproductionmanagementdocumentsandtheactualproductionsituation.Whereanyinconsistencyisfound,rectificationmeasuresshallbetakeninatimelymanner.托生产管理文件和实际生产情况相一致。
24、发现不一致的，应当及时采取整改措施。6. Aregistrantshall,inconjunctionwiththeentrustedmanufacturer,determinethemanagementmethodsofthepurchasedarticlesandsuppliersaccordingtothedegreeofimpactofthepurchasedarticlesontheproducts.Forkeyprocurementarticlesormainrawmaterials,suchasrawmaterialsofanimalorigin,outsourcedsteril
25、izationprocess,keycomponentsandparts/parts/modulesofactiveproducts,antigensandantibodiesofinvitrodiagnosticreagents,etc.purchasedbyanentrustedmanufacturer,theregistrantshalldeterminetheprocurementacceptancecriteriaandreviewtherelevantsuppliersbyitselforinconjunctionwiththeentrustedmanufacturer.（六）注册
26、人应当会同受托生产企业，根据采购物品对产品的影响程度，确定采购物品和供应商的管理方式。对于关键采购物品或者主要原材料，如动物源性原材料、外包的灭菌过程、有源产品的关键元器件/部件/组件、体外诊断试剂的抗原和抗体等，由受托生产企业进行采购的，注册人应当自行或者会同受托生产企业确定采购验收标准、对相关供应商进行审核。（七）受托生产的产品与其他产品（含不同品种、规格、型号等）共用生产场地或者生产设备的，受托生产企业应当基于产品质量风险管理、风险控制措施和收益整体平衡等原则，建立相应管理制度，防止可能发生的产品或者物料混淆、交叉污染、工艺参数误用等风险Q注册人应当加强对受托生产企业的监督和指导，确保相
27、关风险控制措施落实到位。7. Wheretheproductsproduceduponentrustmentsharetheproductionsiteorproductionequipmentwithotherproducts(includingdifferentvarieties,specifications,models,etc.),theentrustedmanufacturershallestablishacorrespondingmanagementsystemundertheprinciplesofproductqualityriskmanagement,riskcontrolm
28、easuresandoverallbalanceofrevenue,topreventpossibleproductormaterialconfusion,cross-contamination,misuseofprocessparametersandotherrisks.Aregistrantshallstrengthenthesupervisionandguidanceoftheentrustedmanufacturertoensurethattherelevantriskcontrolmeasuresareeffectivelyimplemented.（八）注册人委托生产时，应当建立产品
29、上市放行规程，明确放行标准、条件，对医疗器械生产过程记录、质量检验结果和受托生产企业生产放行文件进行审核，符合标准和条件的，经授权的放行人员签字后方可上市。产品上市放行应当由注册人自行完成，不得委托其他企业上市放行Q8. Whenentrustingproduction,aregistrantshalldeveloptheproductmarketingandreleaseprocedures,specifythereleasestandardsandconditions,andreviewtherecordsofthemedicaldeviceproductionprocess,thequa
30、lityinspectionresultsandtheproductionandreleasedocumentsoftheentrustedmanufacturer.Wherethestandardsandconditionsaremet,aproductmaybelistedonlyaftertheauthorizedreleaseofficeraffixessignature.Theproductmarketingandreleaseshallbecompletedbytheregistrantitself,andthemarketingandreleaseshallnotbeentrus
31、tedtoanyotherenterprise.受托生产企业应当建立生产放行规程，明确生产放行的标准、条件，对医疗器械生产过程进行审核，对产品进行检验，确认符合标准、条件的，方可生产放行。Anentrustedmanufacturershalldevelopproductionreleaseprocedures,specifythestandardsandconditionsforproductionandrelease,reviewtheproductionprocessofmedicaldevices,inspecttheproducts,andconfirmthatthestandard
32、sandconditionsaremetbeforeproductionandrelease.产品上市放行、生产放行的记录保存期限，应当符合医疗器械生产质量管理规范相关要求。（九）注册人应当会同受托生产企业，在质量协议中明确纠正预防措施沟通机制、双方职责和处置要求，并制定与产品风险相适宜的纠正预防控制程序。出现产品质量符合性有显著降低趋势，连续多批次中间品或者成品不合格，上市后风险管Therecordkeepingperiodofproductmarketingreleaseandproductionreleaseshallsatisfytherelevantrequirementsofthe
33、productionqualitymanagementspecificationsformedicaldevices.9. Aregistrantshall,inconjunctionwiththeentrustedmanufacturer,specifyinthequalityagreementthecommunicationmechanismforcorrectiveandpreventivemeasures,theresponsibilitiesanddisposalrequirementsofbothparties,anddevelopcorrectiveandpreventiveco
34、ntrolproceduresappropriatetoproductrisks.Whentherearemomentum,systemicorsuddenproblemssuchasatrendofsignificantdecreaseintheconformityofproductquality,consecutive理中的风险事件超出可接受准则等趋势性、系统性、突发性问题时，注册人应当与受托生产企业共同对发现的问题进行调查和分析，制定并评审纠正预防措施计划，实施相关措施并对措施的有效性进行评价。batchesofunqualifiedintermediateorfinishedprodu
35、cts,andriskeventsinriskmanagementaftermarketingexceedingtheacceptablecriteria,theregistrantshalljointlyinvestigateintoandanalyzethediscoveredproblemswiththeentrustedmanufacturer,developandreviewthecorrectiveandpreventiveactionplan,andimplementrelevantmeasuresandevaluatetheireffectiveness.（十）注册人应当强化变
36、更控制能力，会同受托生产企业，建立完善的变更控制程序，做好变更评估、验证或者确认。对于委托研发、生产过程外包和服务外包等外包供方的引入或者变更，应当通过风险评估判定相关变化是否影响质量管理体系有效运行，做好变更控制。10. Aregistrantshallstrengthentheabilityofchangecontrol,andinconjunctionwiththeentrustedmanufacturer,developsoundchangecontrolprocedures,andeffectivelycompletechangeevaluation,verificationorco
37、nfirmation.Fortheintroductionoforchangeinoutsourcingsupplierssuchasentrustedresearchanddevelopment,productionprocessoutsourcingandserviceoutsourcing,riskassessmentshallbeconductedtodeterminewhethertherelevantchangesaffecttheeffectiveoperationofthequalitymanagementsystemandeffectivelyconductchangecon
38、trol.（H一）委托生产的注册人应当按照医疗器械不良事件监测和再评价管理办法等规定，结合产品风险特点，在制度体系建设、机构人员配备、信息收集上报、事件调查处置、风险研究评价等方面，配足资源、完善机制、强化能力，切实承担医疗器械不良事件监测11. Aregistrantentrustingproductionshall,inaccordancewiththeMeasuresfortheAdministrationofMedicalDeviceAdverseEventMonitoringandRe-evaluationandotherprovisionsandinconsiderationoft
39、heriskcharacteristicsofproducts,allocatesufficientresources,improvemechanismsandstrengthencapabilitiesintermsofsystemconstruction,institutionalstaffing,informationcollectionandreporting,incidentinvestigationanddisposal,andriskresearchandevaluation,effectivelyassumetheresponsibilityformonitoringadver
40、seeventsofmedicaldevices,and责任，并在质量协议中约定在不良事件调查处置中委托双方的责任义务。对于医疗器械监督管理条例等法规规定的注册人应当履行的不良事件监测责任，不得通过质量协议向受托生产企业转移。agreeontheresponsibilityandobligationofthetwopartiestoentrustmentintheinvestigationanddisposalofadverseeventsinthequalityagreement.Theadverseeventmonitoringresponsibilitythataregistrantsh
41、allperformasstipulatedintheRegulationontheSupervisionandAdministrationofMedicalDevicesandotherregulationsshallnotbetransferredtotheentrustedmanufacturerthroughthequalityagreement.II.Effectivelymanagementofdevices二、切实强化医疗器械委托生产注册管理strengtheningtheregistrationentrustedproductionofmedical（十二）注册（申请）人委托生
42、产的，应当在质量管理体系文件中明确将受托生产企业的委托生产相关过程纳入注册人质量管理体系覆盖范围，并在注册申报提交的“质量管理体系文件-质量管理体系的测量、分析和改进程序”中涵盖委托方对受托方进行测量、分析和改进的程序及相关资料。12. Aregistrant(applicant)entrustingproductionshall,inthequalitymanagementsystemdocuments,specifytheincorporationoftherelevantentrustedproductionprocessoftheentrustedmanufacturerintothe
43、coveragescopeoftheregistrantsqualitymanagementsystem,andincludeproceduresandrelatedmaterialsoftheentrustingpartyforthemeasurement,analysisandimprovementoftheentrustedpartyintheuQuaIityManagementSystemDocuments-Measurement,AnalysisandImprovementProceduresoftheQualityManagementSystemsubmittedintheregi
44、strationapplication.开展注册质量管理体系核查时，应当重点关注企业质量管理机构建立情况，质量体系关键人员配备和在职履职情况，质量协议签订情况，委托研发和委托生产管理情Intheverificationoftheregistrationqualitymanagementsystem,keyattentionshallbegiventotheformationofenterprisequalitymanagementinstitutions,thestaffingofkeypersonnelofthequalitysystemandtheperformanceoftheirdut
45、ies,thesigningofthequalityagreement,theentrustedresearchanddevelopmentandtheentrustedproductionmanagement.Wheredomesticcross-regionalentrustedproductionisinvolved,fortheverificationoftheregistrationqualitymanagementsystem,inprinciple,themedicalproductsadministrativedepartmentoftheplacewherearegistra
46、nt(applicant)islocatedshall,onitsownorinconjunctionwiththemedicalproductsadministrativedepartmentoftheplacewheretheentrustedmanufacturerislocated,conductacomprehensiveinspectionoftheoperationofthequalitymanagementsystemoftheregistrant(applicant)andtheentrustedmanufacturer.Where,underspecialcircumsta
47、nces,themedicalproductsadministrativedepartmentoftheplacewherearegistrant(applicant)islocatedisreallyunabletodispatchinspectors,itmayentrusttheinspectionoftheentrustedmanufacturertothemedicalproductsadministrativedepartmentoftheplacewheretheentrustedmanufacturerislocated.Themedicalproductsadministra
48、tivedepartmentoftheplacewheretheregistrant(applicant)islocatedshallexamineandconfirmtheverificationreportoftheentrustedmanufacturerinconsiderationoftheverificationoftheregistrant(applicant)system.况等内容。涉及境内跨区域委托生产的，注册质量管理体系核查原则上应当由注册（申请）人所在地药品监督管理部门自行或者联合受托生产企业所在地药品监督管理部门，对注册（申请）人及受托生产企业质量管理体系运行情况进行全
49、面检查。特殊情况下注册（申请）人所在地药品监督管理部门确实无法派出检查人员的，可以委托受托生产企业所在地药品监督管理部门对受托生产企业进行核查，注册（申请）人所在地药品监督管理部门应当结合注册（申请）人体系核查情况对受托生产企业核查报告进行审核确认。（十三）涉及境内委托生产的注册申请或者延续注册申请，注册审批部门应当在医疗器械注册证生产地址栏中登载受托生产地址并注明“（委托生产）“，同时在备注栏备注受托生产企业名称和统一社会信用代码，备注形式为“受托生产企业：XXXX公司；统一社会信用代码：XXXXO变更注册涉及注册人委托生产的，13. Foranapplicationforregistrationoranapplicationforrenewalofregistrationinvolvingdomesticentrustedproduction,theregistrationexaminationdepartmentshallrecor
