【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

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1、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

2、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.

3、atoryDocumentsAreaof1.aw：ImportandExportofMedica1.Devices.Drugs,andMedicineMateria1.sAnnouncementoftheNationa1.Medica1.ProductsAdministrationonIssuingtheMeasuresfortheSupervisionandInspectionofMedica1.DeviceC1.inica1.Tria1.Institutions(forTria1.Imp1.ementation)(AnnouncementNo.222024oftheNationa1.Med

4、ica1.ProductsAdministration)Forthepurposesoffurtherstrengtheningtheadministrationofmedica1.devicec1.inica1.tria1.institutionsandregu1.atingthesupervisionandinspectionofmedica1.devicec1.inica1.tria1.institutions,theNationa1.Medica1.ProductsAdministrationhasorganizedtheformu1.ationoftheMeasuresfortheS

5、upervisionandInspectionofMedica1.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(forTri

6、a1.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,theMeasuresfortheAdministrationofRegi

7、strationandRecordationofIn-VitroDiagnosticReagents,theMeasuresfortheAdministrationoftheConditionsforandFi1.ingofMedica1.DeviceC1.inica1.Tria1.Institutions,andtheGoodC1.inica1.PracticeforMedica1.Devicesforthepurposesofregu1.atingthesupervisionandinspectionofmedica1.devicec1.inica1.tria1.institutionsa

8、ndstrengtheningtheadministrationofmedica1.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.ingofmedica

9、1.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

10、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

11、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,guiding

12、provincia1.medica1.productsadministrativedepartments(provincia1.administrativedepartments)incarryingoutsupervisionandinspectionoftria1.institutions,andfororganizingsupervisionandinspectionsoftria1.institutionsasneeded.TheinspectioninstitutionoftheNMPAisresponsib1.eforestab1.ishingthenationa1.databas

13、eofinspectorsandimp1.ementingthetrainingandmanagementofinspectors,performingtheinspectionoftria1.institutionsorganizedbytheNMPA1andpromotingtheIT-basedfi1.ingoftria1.institutionsandtheIT-basedsupervisionandinspectionwork;iteva1.uatesthequa1.itymanagementsystemforprovincia1.inspectioninstitutionsandp

14、rovidestechnica1.guidanceforprovincia1.inspectionwork.Artic1.e4Theprovincia1.administrativedepartmentsareresponsib1.eforthesupervisionandinspectionofthetria1.institutionswithintheirrespectiveadministrativeregionsandthehand1.ingofre1.evantmattersassignedbytheNMPA1estab1.ishthesupervisionandinspection

15、worksystemandmechanismfortria1.institutions,andarestaffedwithprovincia1.inspectorswhoarequa1.ifiedfortheinspectionofthetria1.institutionsintheprovince;theypromotetheIT-basedsupervisionandinspection;theyorganizedai1.ysupervisionandinspection,causa1.inspection,andotherinspectionsoftria1.institutionswi

16、thintheadministrativeregions,andsupervisesthattria1.institutionscontinuetomeetstatutoryrequirements;theyhand1.ethesuspectedvio1.ationsbytria1.institutionswithintheiradministrativeregionsinaccordancewiththe1.aw.Article 5 Themedica1.productsadministrativedepartmentorinspectioninstitutionconductstheins

17、pectionoftria1.institutionsinaccordancewiththe1.aw,andthemedica1.deviceinspection,review,andotherinstitutionsprovidetechnica1.supportasrequiredbytheinspectionoftria1.institutions.Article 6 Ap1.ywiththerequirementsoftheAdministrativeMeasuresfortheConditionsandFi1.ingofMedica1.DeviceC1.inica1.Tria1.In

18、stitutionsandtheGoodC1.inica1.PracticeforMedica1.Devices,havethecorrespondingprofessiona1.andtechnica1.1.eve1.,organizationa1.andmanagementcapabi1.ities,andethica1.reviewcapabi1.itiestocarryoutc1.inica1.tria1.sofmedica1.devices,estab1.ishaqua1.itymanagementsystemcoveringtheentireprocessofc1.inica1.t

19、ria1.s,soastoensurethattheprincipa1.investigatorsperformtheirc1.inica1.tria1.-re1.atedduties,andprotecttherightsandsafetyofsubjectsandguaranteethatthetria1.resu1.tsaretrue,accurate,comp1.ete,andtraceab1.e.检查，医疗器械检舱、审评等机构根据试骁机构检查工作需要提供技术支撑。笫六条试验机构应当符合医疗器械临床试验机构条件和备案管理办法规定的条件，遵守医疗器械临床试验质量管理规范的要求，具备开展医

20、疗器械临床试脸相应的专业技术水平、组织管理能力、伦理审查能力，建立涵盖临床试验全过程的质量管理制度，确保主要研究者履行其临床试验相关职责，保护受试者的权益和安全，保证试验结果真实、准确、完整、可追溯。Article 7 Accordingtothenatureandpurposeoftheinspection,theinspectionofthetria1.institutionisdividedintodai1.ysupervisioninspection,for-causeinspection,andotherinspections.Differenttypesofinspectionma

21、ybeperformedincombination.第七条根据检查性质和目的，对试跄机构开展的检查分为日常监督检查、有因检查和其他检查。不同类型检杳可以结合进行。（一）日常监督检查是按照年度检查计划，对试验机构及试验专业备案条件是否持续符合要求、试骁机构执行医疗器械临床试建质量管理规范情况、既往检查发现问题的整改情况等开展的监督检查。日常监督检查应当基于风险，结合试脸机构在研临床试验项目情况开展。对于新备案的试验机构，首次监督检查重点核实试脸机(1) Dai1.ysupervisionandinspectionmeansthesupervisionandinspectioncarriedout

22、inaccordancewiththeannua1.inspectionp1.anonwhetherthefi1.ingconditionsforthetria1.institutionandthetria1.specia1.tycontinuetomeettherequirements,theimp1.ementationofthequa1.itymanagementstandardsforc1.inica1.tria1.sofmedica1.devicesbythetria1.institution,andtherectificationofprob1.emsfoundinprevious

23、inspections.Dai1.ysupervisionandinspectionsha1.1.becarriedoutbasedonrisks,andin1.ightofc1.inica1.tria1.projectsunderresearchbytria1.institutions.Fornew1.yfi1.edc1.inica1.tria1.institutions,thefirstsupervisionand构及试骁专业的备案条件。inspectionsha1.1.focusonverifyingthefi1.ingconditionsofc1.inica1.tria1.instit

24、utionsandspecia1.ties.（二）有因检查是对试骏机构可能存在质量安全风险的具体问题或者投诉举报等涉嫌违法违规重要问题线索的针对性检查。有因检查可以不提前通知被检查机构，直接进入检查现场，针对可能存在的问题开展检查。（三）其他检杳是除上述两种检有类型之外的检查，如专项检查、试验机构的监督抽查(2) For-causeinspectionmeansatargetedinspectionofspecificissuesthatatria1.institutionmayhavequa1.ityandsafetyrisksorofc1.uesaboutimportantissuessu

25、spectedofvio1.ations,suchascomp1.aintsandreports.Inthecaseoffor-causeinspection,possib1.eprob1.emsmaybeinspectedattheinspectionsitewithouttheneedtonotifytheinspectedinstitutioninadvance.(3) Otherinspectionsareinspectionsotherthantheaforementionedtwotypesofinspections,suchasspecia1.inspections,andsup

26、en/isionandspotchecksbytria1.institutions.第二章检查机构和人员第八条检查机构应当建立检查质量管理制度，完善检查工作程序，保障检查工作质量；加强检查记录与相关文件档案管理；定期回顾分析检查工作情况，持续改进试验机构检查工作。ChapterI1.InspectionInstitutionsandPersonne1.Artic1.e8Aninspectioninstitutionsha1.1.estab1.ishaninspectionqua1.itymanagementsystemandimprovetheinspectionprocedures,ande

27、nsurethequa1.ityofinspectionwork;strengthenthemanagementofinspectionrecordsandre1.ateddocumentsandarchives;andregu1.ar1.yreviewandana1.yzeinspectionworkandcontinuous1.yimprovetheinspectionworkofthetria1.institution.第九条检查机构按照检查计划组织实施检查任务。试验机构日常监督检查年度计划由省级局结合本行政区域内试验机构和试跄活动的具体情况组织制定；检查应当基于风险选择重点内容，聚焦重

28、点领域、关键环节。Artic1.e9Aninspectioninstitutionsha1.1.organizetheimp1.ementationofinspectiontasksaccordingtotheinspectionp1.an.Theformu1.ationoftheannua1.p1.ansfordai1.ysupervisionandinspectionoftria1.institutionssha1.1.beorganizedbyprovincia1.administrativedepartmentsin1.ightofthespecificconditionsofthet

29、ria1.institutionsandtria1.activitieswithintheiradministrativeregions;theinspectionsha1.1.focusonkeycontentinkeyareasand1.inksbasedonrisks.对试验机构、试骁专业或者主要研究者存在以下情形的，可以纳入检查重点或者提高检查频次：Ifanyofthefo1.1.owingcircumstancesoccurstoatria1.institution,tria1.specia1.ty,orprincipa1.investigator,theymaybeinc1.ude

30、dinthefocusofinspectionortheinspectionfrequencymaybeincreased:（一）2年内临床试骏项目监督检查中发现存在真实性问题的；(1) Itisfoundthatthereareauthenticityprob1.emsinthesupervisionandinspectionofc1.inica1.tria1.projectswithintwoyears;（二）2年内试骁机构监督检查综合评定结论为不符合要求的；(2) Thecomprehensiveeva1.uationconc1.usiononthesupervisionandinspe

31、ctionofthetria1.institutionwithintwoyearsisfai1.uretomeettherequirements;（三）主要研究者同期承担临床试验项目较多、主要研究者管理能力或者研究人员数量相对不足等可能影响试验质量的；(3) A1.argenumberofc1.inica1.tria1.projectsundertakenbytheprincipa1.investigatorinthesameperiod,re1.ative1.ypoormanagementcapacityoftheprincipa1.investigator,ora1.ackofinvest

32、igators,amongotherthings,mayaffectthequa1.ityofthetria1.;（四）投诉举报或者其他线索提示存在质量安全风险的；(4) Comp1.aintsorotherc1.uessuggestthattherearequa1.ityandsafetyrisks;or（五）其他表明试验机构可能存在质量管理风险的，例如：试验机构超过2年未开展临床试跄，后续恢复开展试验的。笫十条检查人员应当具备相应的检查资质和能力；应当严格遵守法律法规、廉政纪律和工作要求，不得向被检查机构提出与检查无关的要求；在检查前应当接受廉政教育，(5) Otherindication

33、sthatthetria1.institutionmayhavequa1.itymanagementrisks.Forexamp1.e,thetria1.institutionhasnotconductedc1.inica1.tria1.sformorethantwoyearsandthenresumesthetria1.s.Artic1.e10Inspectorssha1.1.havecorrespondinginspectionqua1.ificationsandabi1.ityandstrict1.yabideby1.awsandregu1.ations,integritydiscip1

34、.ines,andworkrequirements,andsha1.1.notraiserequirementsirre1.evanttoinspectiontotheinspectedinstitution.Theysha1.1.receiveintegrityeducationbeforetheinspectionandsigna1.etterof签署承诺书和无利益冲突声明；与被检查机构存在利益关系或者有其他可能影响检查结果公正性的情况时，应当主动声明并回避。笫十一条检查人员应当严格遵守保密规定和检查纪律，并签署保密协议，严格管理涉密资料，严防泄密事件发生。不得泄露检查相关信息及被检查机构

35、技术或者商业秘密等信息。commitmentandastatementonnoconf1.ictsofinterest;andvo1.untari1.ymakestatementsandwithdrawfromtheinspectioniftheyhaveanyinterestintheinspectedinstitutionorfa1.1.underanyothercircumstancewhichmayaffecttheimpartia1.ityofinspectionresu1.ts.Artic1.e11Inspectorssha1.1.strict1.yabidebytheprovis

36、ionsonconfidentia1.ityandinspectiondiscip1.ine,signconfidentia1.ityagreements,strict1.ymanageconfidentia1.information,andstrict1.ypreventthe1.eakageofconfidentia1.information.Theysha1.1.notdivu1.geanyinformationre1.atingtotheinspectionortechnica1.ortradesecretsoftheinspectedinstitution.第三章检查程序Chapte

37、rIIIInspectionProcedures笫十二条实施检查前，检杳机构应当根据检查任务制定具体检查方案，明确检杳内容、检查时间和检查方式等。检查方式以现场检查为主，可视情况开展远程检查。Artic1.e12Beforeaninspection,theinspectioninstitutionsha1.1.formu1.ateaspecificinspectionp1.anaccordingtotheinspectiontasks,andspecifytheinspectioncontent,inspectiontime,andinspectionmethod.On-siteinspect

38、ionsha1.1.bemain1.yadoptedforinspection,andremoteinspectionmaybeconductedasthecasemaybe.第十三条检查机构组建检查组实施检查。检查组一般由2名以上检查员组成，实行组长负责制，必要时可以增加相关领域专家参加检查工作。检查人员应当提前熟悉检查方案以及检查相关资料。Artic1.e13Aninspectioninstitutionsha1.1.setupaninspectionteamtoconductinspections.Theinspectionteamgenera1.1.yconsistsoftwoormo

39、reinspectorsandissubjecttotheteam1.eaderresponsibi1.itysystem.Ifnecessary,expertsinre1.evantfie1.dsmaybea1.1.owedtoparticipateintheinspection.Inspectorssha1.1.befami1.iarwiththeinspectionp1.anandinspection-re1.atedmateria1.sinadvance.第十四条确定检查时间后，检查机构原则上在检查前5至7个工作日通知被检查机Artic1.e14Aftertheinspectionti

40、meisdetermined,aninspectioninstitutionsha1.1.,inprincip1.e,notifytheinspectedinstitutionfivetosevenworkingdays构，有因检查除外。国家局检查机构实施的试验机构检查，应当同时通知被检查机构所在地省级局。省级局应当选派1名医疗器械监督管理人员作为观察员协助检查工作，并将检查发现的问题等及时报告省级局。beforetheinspection,exceptforafor-causeinspection.Fortheinspectionofatria1.institutioncarriedoutb

41、yaninspectioninstitutionundertheNMPA,theprovincia1.administrativedepartmentatthep1.acewheretheinspectedinstitutionis1.ocatedsha1.1.benotifiedatthesametime.Theprovincia1.administrativedepartmentsha1.1.appointonemedica1.deviceregu1.atoryofficerasanobservertoassistintheinspection,andprompt1.yreportthep

42、rob1.emsfoundintheinspectiontotheprovincia1.administrativedepartment.笫十五条检查组开始现场检查时，应当召开首次会议（有因检查除外），向被检查机构出示并宣读检查通知，确认检查范围，告知检查纪律、廉政纪律、注意事项以及被检查机构享有的权利和应当蝮行的义务。被检查机构应当积极配合检查组工作，安排研究者、其他熟悉业务的相关人员协助检查组工作，及时提供相关资料，并保证所提供的资料、数据及相关情况真实、准确、完整、可追溯，不得拒绝、逃避、拖延或者阻碍检查。Artic1.e15Instartinganon-siteinspection,a

43、ninspectionteamsha1.1.conveneapre1.iminarymeeting(exceptforthefor-causeinspection)topresentandreadouttheinspectionnoticetotheinspectedinstitution,confirmthescopeoftheinspection,andinformtheinspectedinstitutionofinspectiondiscip1.ine,integritydiscip1.ine,precautions,aswe1.1.astherightsenjoyedbyandob1

44、.igationstobefu1.fi1.1.edbytheinspectedinstitution.Theinspectedinstitutionsha1.1.active1.ycooperatewiththeinspectionteam,arrangeforinvestigatorsandotherre1.evantpersonne1.whoarefami1.iarwiththebusinesstoassisttheinspectionteam,providere1.evantmateria1.sinatime1.ymanner,andensurethatthemateria1.s,dat

45、a,andre1.evantinformationprovidedaretrue,accurate,comp1.ete,andtraceab1.e,andsha1.1.notrefuse,evade,de1.ay,orobstructtheinspection.笫十六条检查组应当根据检查方案实施检查。检查过程中检查方案需变更的，应当报告检查机构同意后实施。Artic1.e16Theinspectionteamsha1.1.conducttheinspectionaccordingtotheinspectionp1.an.Ifitisnecessarytochangetheinspectionp

46、1.anduringaninspection,suchchangesha1.1.bereportedtotheinspectioninstitutionforapprova1.beforeimp1.ementation.Artic1.e17Theinspectionteamsha1.1.keepdetai1.edrecordsof,amongotherthings,theinspectiontime,p1.ace,content,andprob1.emsdiscovered,andretainthere1.evantevidencefortheprob1.emsdiscovered,accor

47、dingtotheactua1.circumstances.笫十七条检查组应当详细记录检查时间、地点、内容、发现的问题等，并根据实际情况对发现的问题留存相关证据。Artic1.e18Theinspectionteamsha1.1.summarizeandana1.yzetheon-siteinspectioninformationandconductariskassessmentandgradingofthedeficienciesdiscoveredintheinspectioninanobjective,fair,andimpartia1.manner.Iftheinspectiontea

48、mconsidersuponassessmentthattherearequa1.ityandsafetyrisks,itsha1.1.requiretheinspectedinstitutiontoprompt1.ycontro1.risks.Whennecessary,themedica1.productsadministrativedepartmentsha1.1.requirethetria1.institutiontotakefurtherriskcontro1.measures.笫十八条检查组应当对现场检查情况进行汇总分析，客观、公平、公正地对检查发现的缺陷进行风除评估和分级；检查组评估认为存在质量安全风险的，应当要求被检查机构及时控制风险；必要时由药品监督管理部门要求试验机构采取进一步风险控制措施。第十九条现场检查结束时，检查组应当召开末次会议，向被检查机构通报现场检查情况。被检有机构对现场检查情况有异议的，可以陈述申辩，检查组应当如实记录，并结合陈述申辩的内容确定发现的缺陷，形成缺陷项目清单。缺陷项目清单由检查组成员、被检查机构负责人、观察员（如适用）绦字确认，加羞被检查机构公章。被检查机构对检查结论有异议，拒不签字的，由检查组成员和观察员签