【中英文对照版】医疗器械经营质量管理规范（2023）.docx

国家药监局关于发布医疗器械经营质 量管理规范的公告（国家药品监督管理局公告2023年 第153号）为加强医疗器械经营质量管理，规范 医疗器械经营行为，促进行业规范发 展，保障公众用械安全有效，根据相 关法规规章规定，国家药监局修订了 医疗器械经营质量管理规范，现 予发布，自2024年7月1日起施 行，原国家食品药品监督管理总局 关于施行医疗器械经营质量管理规 范的公告（2014年第58号）同时 废止。医疗器械经营质量管理规范(2023)GoodDistributionPracticesforMedicalDevices(2023)制定机关：国家药品监督管理局(已变更)发文字号：国家药品监督管理局公告2023年第153号公布日期：2023.12.04施行日期：2024.07.01效力位阶：部门规范性文件法规类别：医疗器械药品药材进出口质量综合规定IssuingAuthority：StateDrugSupenision&AdministrationBureau(replaced)DocumentNumber：AnnouncementNo.1532023oftheNationalMedicalProductsAdministrationDateIssued：12-04-2023EffectiveDate：07-01-20241.evelofAuthority：DepartmentalRegulatoryDocumentsAreaofLaw:ImportandExportofMedicalDevices,Drugs,andMedicineMaterialsGeneralProvisionsonQualityAnnouncementoftheNationalMedicalProductsAdministrationonIssuingtheGoodDistributionPracticesforMedicalDevices(AnnouncementNo.1532023oftheNationalMedicalProductsAdministration)Forthepurposesofstrengtheningthequalitymanagementofmedicaldevicedistribution,standardizingthebehaviorsofmedicaldevicedistribution,promotingthestandardizeddevelopmentoftheindustry,andensuringthesafetyandeffectivenessofpublicequipment,accordingtotheprovisionsoftherelevantlawsandregulations,theNationalMedicalProductsAdministrationhasrevisedtheGoodDistributionPracticesforMedicalDevices,whichareherebyissuedandshallcomeintoforceonJuly1,2024,uponwhichtheAnnouncementonImplementingtheGoodDistributionPracticesforMedicalDevices(No.582014)issuedbytheformerChinaFoodandDrugAdministrationshallberepealed.特此公告。Annex:GoodDistributionPracticesforMedicalDevices附件：医疗器械经营质量管理规范NationalMedicalProductsAdministration国家药监局December4,20232023年12月4日Annex附件GoodDistributionPracticesforMedicalDevices医疗器械经营质量管理规范ChapterIGeneralProvisions第一章总则Article1Forthepurposesofstrengtheningthequalitymanagementofmedicaldevicedistribution,regulatingbusinessactivitiesofmedicaldevices,andguaranteeingthesafetyandeffectivenessofmedicaldevices,thesePracticesaredevelopedinaccordancewiththeprovisionsoftheRegulationontheSupervisionandAdministrationofMedicalDevices,theMeasuresfortheSupervisionandAdministrationofMedicalDeviceBusiness,andotherlawsandregulations.笫一条为了加强医疗器械经营质量管理，规范医疗器械经营活动，保证医疗器械安全、有效，根据医疗器械监督管理条例医疗器械经营监督管理办法等法规规章的规定，制定本规范。Article2ThesePracticesarethebasicrequirementsforthequalitymanagementofmedicaldevicedistribution.Whencarryingoutmedicaldevicedistributionactivities,effectivequalitymanagementmeasuresshallbetakeninthewholeprocessofprocurement,acceptance,storage,sale,transportation,after-salesservice,etc.ofmedicaldevices,toensurethequalitysafetyandtraceabilityofmedicaldeviceproductsinthebusinessprocess.Article3MedicaldevicedistributorsshallstrictlyimplementthesePractices.第二条本规范是医疗器械经营质量管理的基本要求。从事医疗器械经营活动，应当在医疗器械采购、验收、贮存、销售、运输、售后服务等全过程采取有效的质量管理措施，确保医疗器械产品在经营过程中的质量安全与可追溯。第三条医疗器械经营企业应当严格执行本规范。Medicaldeviceregistrantsandrecordationhandlerssellingtheirregisteredorrecordedmedicaldevices,andinvolvingotherstorageandtransportationofmedicaldevicesintheprocessofcirculationofmedicaldevicesshallsatisfytherelevantrequirementsofthesePractices.医疗器械注册人、备案人销售其注册或者备案的医疗器械，以及医疗器械流通过程中其他涉及贮存与运输医疗器械的，应当符合本规范的相关要求。Article4Medicaldeviceregistrantsandrecordation笫四条医疗器械注册人、备案人依法对上市医疗器械的安全、有效 负责，医疗器械经营企业（以下简称 企业）对本企业的经营行为负责。笫五条从事医疗器械经营活 动，应当按照所经营医疗器械的风险 程度实行风险管理，并采取相应的质 量管理措施。第六条企业及其从业者应当诚 实守信、依法经营，禁止任何虚假、 欺骗行为。第七条鼓励企业使用信息化手 段传递和存储相关政府管理部门制作 的电子证照。电子证照与纸质证书具有同等法律效 力O笫八条鼓励企业运用先进的质 量管理工具与方法实施质量管理，持 续改进质量管理体系。鼓励企业数字 化、智能化、绿色化发展，提升医疗 器械供应链效率与质量安全，促进行 业高质量发展。第二章质量管理体系建立与改进笫九条 企业应当建立健全符合 本规范要求的质量管理体系。质量管 理体系应当与企业的经营范围和经营 规模相适应，包括质量管理体系文 件、组织机构、人员、设施设备等。handlersshallberesponsibleforthesafetyandeffectivenessofmedicaldeviceslistedaccordingtothelaw,andmedicaldevicedistributors(hereinafterreferredtoas“enterprises")shallberesponsiblefortheirbusinessbehaviors.Article5Forcarryingoutmedicaldevicebusinessactivities,riskmanagementshallbeimplementedaccordingtotheriskdegreeofmedicaldevices,andcorrespondingqualitymanagementmeasuresshallbetaken.Article 6 Enterprisesandtheirpractitionersshallbehonestandtrustworthy,carryoutbusinessoperationaccordingtothelaw,andprohibitanyfalseordeceptivebehavior.Article 7 Anenterpriseshallbeencouragedtouseinformation-basedmeanstotransferandstoreelectroniclicensesproducedbyrelevantgovernmentadministrativedepartments.Electroniccertificatesandlicenses,aswellaspapercertificatesshallhavethesamelegaleffect.Article 8 Anenterpriseshallbeencouragedtouseadvancedqualitymanagementtoolsandmethodstoimplementqualitymanagementandcontinuouslyimprovethequalitymanagementsystem.Thedigital,intelligentandgreendevelopmentofenterprisesshallbeencouraged,theefficiencyandqualitysafetyofthemedicaldevicesupplychainshallbeimproved,andthehigh-qualitydevelopmentoftheindustryshallbepromoted.Chapter II EstablishmentandImprovementoftheQualityManagementSystemArticle9AnenterpriseshallestablishandimprovethequalitymanagementsysteminlinewiththerequirementsofthesePractices.Thequalitymanagementsystemshallbecompatiblewiththebusinessscopeandscaleofanenterprise,includingthedocumentsofthequalitymanagementsystem,institutionalframework,personnel,facilitiesandequipment,etc.Article10Anenterpriseshallbeencouragedtodevelopqualitypoliciesandqualityobjectives.Thequalitypolicyandqualityobjectivesshallsatisfytherequirementsofapplicablelaws,regulations,rulesandnormsandconformtotheactualcircumstancesofenterprises,andtherelevantrequirementsshallbeimplementedinthewholeprocessofbusinessactivitiesofmedicaldevices.Article11Anenterpriseshallfulfilltheresponsibilityforthequalityandsafetyofmedicaldevicesinaccordancewiththelaw,providenecessaryresourcesandinstitutionalguarantees,guaranteetheeffectiveoperationofthequalitymanagementsystem,andensurethatpersonnelinkeyqualityandsafetypositionseffectivelyperformtheirdutiesandparticipateinqualitymanagement,andpersonnelinrelevantdepartmentsandholdingrelevantpositionscorrectlyunderstandandperformtheirdutiesandassumecorrespondingqualityresponsibilities.Article12AnenterprisedistributingmedicaldevicesofClassIlandClassIIIshallconductself-inspectioninaccordancewiththerequirementsofthesePracticesandthequalitymanagementself-inspectionsystem,andsubmittheself-inspectionreportforthepreviousyeartothemedicinalproductregulatorydepartmentofthecountyandmunicipallevelwhereitislocatedbeforeMarch31eachyear.Thecontentofaself-inspectionreportshallbeauthentic,accurate,integralandretrospective.Article13Anenterpriseshallusequalitymanagementtechnologiesandmethodstocontinuouslyimprovethequalitymanagementsystemandmaintainthesuitability,adequacyandeffectivenessofthequalitymanagementsystemaccordingtotheriskdegreeofthebusinessproducts,thequalitysafetyrisksituationandtheselfinspectionofqualitymanagement,amongothers.Chapter III ResponsibilitiesandSystems第十条 鼓励企业制定质量方针 和质量目标。质量方针和质量目标应 当满足适用的法律、法规、规章、规 范的要求并符合企业实际，相关要求 应当贯彻到医疗器械经营活动的全过 程。笫十一条 企业应当依法履行医 疗器械质量安全责任，提供必要的资 源和制度保障，保证质量管理体系有 效运行，确保质量安全关键岗位人员 有效履行职责、全员参与质量管理， 各有关部门、岗位人员正确理解并履 行职责，承担相应质量责任。笫十二条从事第二类、第三类 医疗器械经营的企业，应当按照本规 范以及质量管理自查制度要求进行自 查，每年3月31日前向所在地市县 级药品监督管理部门提交上一年度的 自查报告。自查报告内容应当真实、 准确、完整和可追溯。第十三条 企业应当根据经营产 品的风险程度、质量安全风险情况和 质量管理自查情况等，运用质量管理 技术与方法，持续改进质量管理体 系，保持质量管理体系的适宜性、充 分性和有效性。第三章职责与制度笫十四条企业质量安全关键岗 位人员包括企业负责人、质量负责人 和质量管理人员，其中企业负责人为 最高管理者，质量负责人为高层管理 人员或者质量管理机构负责人。Article14Personnelholdingkeyqualityandsafetypositionsofanenterpriseshallincludethepersoninchargeoftheenterprise,thepersoninchargeofqualityandthequalitycontroller,ofwhichthepersoninchargeoftheenterpriseisthechiefexecutive,andthequalitycontrolleristheseniorexecutiveorthepersoninchargeofthequalitymanagementinstitution.Article15Anenterpriseshall,undertheprincipleof“consistencyofpowerandresponsibility,assigningresponsibilitiestospecificpersons,selectingpersonnelforspecificpositions,andsuitabilityofpersonnelandposition,setupkeyqualityandsafetypositions,appointpersonnelofkeyqualityandsafetypositionscommensuratewiththescopeandscaleofbusiness,andprovidenecessaryresourcesandinstitutionalguaranteesfortheirperformanceofdutiestoensurethatpersonnelholdingkeyqualityandsafetypositionsfullyperformtheirduties.Article16Apersoninchargeofanenterpriseshallbefullyresponsibleforthequalityandsafetyworkoftheenterprise'smedicaldevices,providenecessaryconditionstoguaranteethatthepersoninchargeofqualityandqualitycontrollereffectivelyperformtheirduties,andensurethattheenterprisedistributesmedicaldevicesinaccordancewiththerelevantlaws,regulations,rulesandtherequirementsofthesePractices;andbeforemakingmajordecisionsconcerningthequalityandsafetyofmedicaldevices,thepersoninchargeoftheenterpriseshallfullylistentotheopinionsandsuggestionsofthepersoninchargeofqualityandqualitycontroller,organizeresearchonthepotentialhazardsofqualityandsafetyoftheenterprisefoundbythemandputforwarddisposalmeasurestoeliminatethepotentialhazardsofrisksinatimelymanner.Article17Apersoninchargeofanenterpriseshalllistentotheworkreportofthepersoninchargeofqualityatleastonceaquarter,conductworkconsultationandsummaryoftheenterprise'sdistributionqualityandsafetyrisks,makeschedulingarrangementsforkeywork,andformminutesoftheconsultationmeetingsofmedicaldevicequalityandsafetyrisks.Aconsultationmeetingshallbeattendedbypersonnelholdingkeyqualityandsafetypositionsofanenterpriseandtherelevantdepartmentsinvolvedinqualityandsafetyrisks.笫十五条 企业应当按照“权责 一致、责任到人、因岗选人、人岗相 适”的原则，设置质量安全关键岗 位，配备与经营范围和经营规模相适 应的质量安全关键岗位人员，并为其 履职提供必要的资源和制度保障，确 保质量安全关键岗位人员充分履行职 责。第十六条企业负责人应当对本 企业医疗器械质量安全工作全面负 责，提供必要的条件，保证质量负责 人、质量管理人员有效履行职责，确 保企业按照相关法律、法规、规章和 本规范要求经营医疗器械；企业负责 人作出涉及医疗器械质量安全的重大 决策前，应当充分听取质量负责人、 质量管理人员的意见和建议，对其发 现的本企业质量安全隐患，应当组织 研究并提出处置措施，及时消除风险 隐患。笫十七条企业负责人应当每季 度至少听取一次质量负责人工作情况 汇报，对企业经营质量安全风险情况 进行工作会商和总结，对重点工作作 出调度安排，形成医疗器械质量安全 风险会商会议纪要。会商会议应当有 企业质量安全关键岗位人员以及质量 安全风险情况涉及的相关部门参加。笫十八条企业质量负责人负责 医疗器械质量管理工作，应当独立履 行职责，在企业内部对医疗器械质量 管理具有裁决权，承担相应的质量管Article18Apersoninchargeofqualityshallbeinchargeofthequalitymanagementofmedicaldevices,performdutiesindependently,havediscretionoverthequalitymanagementofmedicaldevicesintheenterprise,andassumecorrespondingqualitymanagementresponsibilities.理责任。笫十九条企业应当具有与经营 范围和经营规模相适应的质量管理机 构或者质量管理人员。企业质量管理 机构或者质量管理人员应当履行下列 职责：（一）负责收集和管理与医疗器械经 营相关的法律、法规、规章、规范和 有关规定等与质量管理相关的信息， 建立医疗器械质量档案，实施动态管 理，并督促相关部门和岗位人员执 行；Article19Anenterpriseshallhaveaqualitymanagementinstitutionorqualitycontrollercommensuratewithitsbusinessscopeandscale.Anenterprise'squalitymanagementinstitutionorqualitycontrollershallperformthefollowingduties:(1)Beingresponsibleforcollectingandmanaginglaws,regulations,rules,practicesandrelevantprovisionsrelatedtomedicaldevicedistribution,aswellastheinformationrelatedtoqualitymanagement,creatingmedicaldevicequalityfiles,implementingdynamicmanagement,andurgingrelevantdepartmentsandpersonnelholdingrelevantpositionstoimplementthem.(2) Beingresponsiblefororganizingthedevelopmentofthequalitymanagementsystem,guidingandsupervisingtheimplementationofthesystem,andinspecting,correctingandcontinuouslyimprovingtheimplementationofthequalitymanagementsystem.(3) Beingresponsibleforthemanagementofthequalitycontrolfunctionandoperationpowerofthecomputerinformationsystemrelatedtomedicaldevicedistribution.(4) Beingresponsibleforimplementingmedicaldevicetraceabilitymanagement,andpromotingtheimplementationoftheuniqueidentificationsystemofmedicaldevices.（二）负责组织制定质量管理制度，指导、监督制度的执行，并对质量管理制度的执行情况进行检查、纠正和持续改进；（三）负责对医疗器械经营相关的计算机信息系统的质量控制功能和操作权限进行管理；（四）负责实施医疗器械追溯管理,推进医疗器械唯一标识制度实施；(5)Beingresponsibleforreviewingthequalificationsofmedicaldevicesuppliers,productsandpurchasers,andimplementingdynamicmanagement.（五）负责对医疗器械供货者、产品、购货者资质的审核，并实施动态管理；(6)Beresponsibleforconfirmingunqualifiedmedicaldevices,andsupervisingthehandlingprocessofunqualifiedmedicaldevices.（六）负责不合格医疗器械的确认，对不合格医疗器械的处理过程实施监督；(7)Beingresponsiblefortheinvestigation,handlingandreportofcomplaintsaboutqualityandqualityaccidentsofmedicaldevices.（七）负责医疗器械质量投诉和质量事故的调查、处理及报告；（八）负责医疗器械召回的管理;(8) Beingresponsibleformanagingrecallingofmedicaldevices.（九）负责医疗器械质量安全风险会 商的组织实施；(9) Beingresponsiblefortheorganizationandimplementationofconsultationonqualitysafetyrisksofmedicaldevices.（十）组织医疗器械不良事件的收集 与报告；(10) Organizingcollectionandreportofadverseeventsofmedicaldevices.（十一）组织验证、校准相关设施设 备；(11) Organizingverificationandcalibrationofrelevantfacilitiesandequipment.（十二）组织对受托运输承运方进行 质量保障能力审核及质量监督；(12) Organizingreviewandqualitysupervisionoverthequalityassurancecapabilityoftheentrustedtransportcarrier.（十三）组织对专门提供医疗器械运 输、贮存服务的企业质量保障能力审 核及产品质量监督；(13) Organizingreviewofthequalityassurancecapabilityandsupervisionoverproductqualityofenterprisesspecializinginprovidingmedicaldevicetransportationandstorageservices.（十四）组织对医疗器械网络销售相 关过程进行质量保障能力审核以及质 量监督；(14) Organizingreviewofthequalityassurancecapabilityandqualitysupervisionovertherelevantprocessofonlinesaleofmedicaldevices.（十五）组织质量管理自查和各项专 项自查，按时提交自查报告；(15) Organizingself-inspectionofqualitymanagementandspecialself-inspections,andsubmittingself-inspectionreportsasscheduled.（十六）组织或者协助开展质量管理 培训；(16) Organizingorassistinginprovidingqualitymanagementtraining.（十七）其他应当由质量管理机构或 者质量管理人员履行的职责。(17) Otherdutiesthatshallbeperformedbythequalitymanagementinstitutionorqualitycontroller.笫二十条 企业应当依照本规范 建立覆盖医疗器械经营全过程的质量 管理体系文件。质量管理体系文件应Article20AnenterpriseshallpreparedocumentsofthequalitymanagementsystemcoveringthewholeprocessofmedicaldevicedistributioninaccordancewiththesePractices.Thedocumentsofthequalitymanagement当符合企业实际，并实施动态管理， 确保文件持续有效。质量管理体系文 件应当由企业负责人批准后实施，并 至少包括下列内容：systemshallconformtotheactualcircumstancesofanenterprise,andimplementdynamicmanagementtoensurethatthedocumentscontinuetobeeffective.Thedocumentsofthequalitymanagementsystemshallbeimplementedwithapprovalofthepersoninchargeoftheenterprise,andatleastincludethefollowingcontents:(1)Managementresponsibilitiesofthemanagementinstitutionorqualitycontroller.quality（一）质量管理机构或者质量管理人员管理职责；(2)Positiondescriptionsforpersonnelholdingkeyqualityandsafetypositions.（二）质量安全关键岗位人员岗位说明；(3)Qualitydocumentreviewandapprovalmanagementsystem.（三）质量文件审核批准管理制度;(4)Qualityrecordmanagementsystem.（四）质量记录管理制度;(5)Self-inspectionsystemforqualitymanagement.（五）质量管理自查制度;(6)Medicaldevicesuppliersreviewsystem.andproductqualification（六）医疗器械供货者和产品资质审核制度；(7)Managementdevices.systemforprocurementofmedical（七）医疗器械采购管理制度；(8)procurementdevices.receiptandacceptanceofmedical（八）医疗器械收货和验收管理制度；(9)Managementsystemformedicaldevice(display)andinspectioninthewarehouse.storage（九）医疗器械贮存（陈列）和在库检查管理制度；(10)Managementsystemforwarehouse-inandwarehouse-outofmedicaldevices.（十）医疗器械出入库管理制度;(11)Managementsystemforvalidityofmedicaldevices.（十一）医疗器械效期管理制度;(12)Managementsystemfortransportationofmedicaldevices.（十二）医疗器械运输管理制度;(13)Managementsystemforsalesandafter-salesservicesofmedicaldevices.（十三）医疗器械销售和售后服务管理制度；(14)Managementsystemforunqualifiedm