【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 EstablishmentandImprovementoftheQualityManagementSystemArticle9Anenterpriseshallestablishandimprovethequalitymanagementsys
