【中英文对照版】医疗器械临床试验机构监督检查办法(试行).docx

国家药监局关于发布医疗器械临床试验机构监督检查办法（试行）的通告（国家药监局公告2024年第22号）为进一步加强对医疗器械临床试验机构的管理，规范医疗器械临床试验机构监督检查工作，国家药监局组织制定了医疗器械临床试验机构监督检查办法（试行），现予发布，自2024年10月1日起实施。医疗器械临床试睑机构监督检查办法(试行)MeasuresfortheSupervisionandInspectionofMedica1.DeviceC1.inica1.Tria1.Institutions(forTria1.Imp1.ementation)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22号公布日期：2024.06.14施行日期：2024.10.01效力住阶：部门规范性文件法规类别：医疗公做礼品药材进出口IssuingAUthOrity：StateDrugSupcnision&AdministrationBureau(rep1.aced)DocumentNumber：AnnouncementNo.222024oftheNationa1.Medica1.Products/XdministrationDateIssued：(Xi-14-2024EffectiveDate：10-01-20241.eve1.ofAuthority：Departmenta1.Regu1.atoryDocumentsAreaof1.aw：ImportandExportofMedica1.Devices.Drugs,andMedicineMateria1.sAnnouncementoftheNationa1.Medica1.ProductsAdministrationonIssuingtheMeasuresfortheSupervisionandInspectionofMedica1.DeviceC1.inica1.Tria1.Institutions(forTria1.Imp1.ementation)(AnnouncementNo.222024oftheNationa1.Medica1.ProductsAdministration)Forthepurposesoffurtherstrengtheningtheadministrationofmedica1.devicec1.inica1.tria1.institutionsandregu1.atingthesupervisionandinspectionofmedica1.devicec1.inica1.tria1.institutions,theNationa1.Medica1.ProductsAdministrationhasorganizedtheformu1.ationoftheMeasuresfortheSupervisionandInspectionofMedica1.DeviceC1.inica1.Tria1.Institutions(forTria1.Imp1.ementation),whichareherebyissued,eintoforceonOctober1,2024.特此通告。国家药监局Nationa1.Medica1.ProductsAdministrationJune14,20242024年6月14日MeasuresfortheSupervisionandInspectionofMedica1.DeviceC1.inica1.Tria1.Institutions(forTria1.Imp1.ementation)医疗器械临床试验机构监督检查办法（试行）ChapterIGenera1.Provisions第一章总则Artic1.e1TheseMeasuresaredeve1.opedinaccordancewiththeRegu1.ationontheSupervisionandAdministrationofMedica1.Devices,theMeasuresfortheAdministrationofRegistrationandRecordationofMedica1.Devices,theMeasuresfortheAdministrationofRegistrationandRecordationofIn-VitroDiagnosticReagents,theMeasuresfortheAdministrationoftheConditionsforandFi1.ingofMedica1.DeviceC1.inica1.Tria1.Institutions,andtheGoodC1.inica1.PracticeforMedica1.Devicesforthepurposesofregu1.atingthesupervisionandinspectionofmedica1.devicec1.inica1.tria1.institutionsandstrengtheningtheadministrationofmedica1.devicec1.inica1.tria1.s.第一条为规范医疗器械临床试脸机构监督检查工作，加强医疗器械临床试验管理，根据医疗器械监督管理条例医疗器械注册与备案管理办法体外诊断试剂注册与备案管理办法医疗器械临床试脸机构条件和备案管理办法医疗器械临床试验质量管理规范等，制定本办法。Artic1.e2TheseMeasuresapp1.ytotheinspectionanddisposa1.bythemedica1.productsadministrativedepartmentoffi1.ingofmedica1.devicec1.inica1.tria1.institutions(utria1.institutions")andtheirmedica1.devicec1.inica1.tria1.sdesignedfortheregistrationofmedica1.devices(inc1.udinginvitrodiagnosticreagents)andqua1.itymanagementstandardsforc1.inica1.tria1.sofmedica1.devicesperformedbythem.笫二条药品监督管理部门对医疗器械临床试验机构（以下简称试骁机构）备案及开展以医疗器械（含体外诊断试剂，下同）注册为目的的医疗器械临床试验活动，执行医疗器械临床试览质量管理规范等情况实施检查、处置等，适用本办法。Artic1.e3TheNationa1.Medica1.ProductsAdministration("NMPA")isresponsib1.efor第三条国家药品监督管理局（以下简称国家局）负责制定试验机构监督检查办法,指导省级药品监督管理部门（以下简称省级局）开展试脸机构监督检查，根据需要组织对试脸机构进行监督检查。国家局检查机构负责建立国家检查员库并实施检查员培训与管理，负责实施国家局组织开展的试验机构检查，推进试验机构备案管理信息化及监督检查工作信息化建设；对省级检查机构质量管理体系进行评估，对各省检查工作进行技术指导。第四条省级局负责本行政区域内试赘机构的监督检查以及国家局交办的有关事项办理，建立试验机构监督检杳工作制度和机制，配备与本省试脸机构检查工作相匹配的省级检查员队伍；推进监督检查工作信息化建设：组织对本行政区域内试验机构开展日常监督检查、有因检查和其他检查等，监督试验机构持续符合法定要求；对本行政区域内试骏机构涉嫌违法违规行为依法进行处置。第五条药品监督管理部门检查机构依法开展试验机构formu1.atingmeasuresforthesupervisionandinspectionoftria1.institutions,guidingprovincia1.medica1.productsadministrativedepartments("provincia1.administrativedepartments")incarryingoutsupervisionandinspectionoftria1.institutions,andfororganizingsupervisionandinspectionsoftria1.institutionsasneeded.TheinspectioninstitutionoftheNMPAisresponsib1.eforestab1.ishingthenationa1.databaseofinspectorsandimp1.ementingthetrainingandmanagementofinspectors,performingtheinspectionoftria1.institutionsorganizedbytheNMPA1andpromotingtheIT-basedfi1.ingoftria1.institutionsandtheIT-basedsupervisionandinspectionwork;iteva1.uatesthequa1.itymanagementsystemforprovincia1.inspectioninstitutionsandprovidestechnica1.guidanceforprovincia1.inspectionwork.Artic1.e4Theprovincia1.administrativedepartmentsareresponsib1.eforthesupervisionandinspectionofthetria1.institutionswithintheirrespectiveadministrativeregionsandthehand1.ingofre1.evantmattersassignedbytheNMPA1estab1.ishthesupervisionandinspectionworksystemandmechanismfortria1.institutions,andarestaffedwithprovincia1.inspectorswhoarequa1.ifiedfortheinspectionofthetria1.institutionsintheprovince;theypromotetheIT-basedsupervisionandinspection;theyorganizedai1.ysupervisionandinspection,causa1.inspection,andotherinspectionsoftria1.institutionswithintheadministrativeregions,andsupervisesthattria1.institutionscontinuetomeetstatutoryrequirements;theyhand1.ethesuspectedvio1.ationsbytria1.institutionswithintheiradministrativeregionsinaccordancewiththe1.aw.Article 5 Themedica1.productsadministrativedepartmentorinspectioninstitution