英文版医疗器械临床试验质量管理规范.docx

英文版医疗器械临床试验质量管理规范.docx

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英文版医疗器械临床试验质量管理规范

FG-20160601025

GoodClinicalPracticeforMedicalDevices

（No.25OrderofCFDAandNHFPC）

OrderofChinaFoodandDrugAdministrationandNationalHealthandFamilyPlanningCommissionofChina

No.25

AdoptedatthemeetingofCFDAandNHFPC,thispracticeisherebypromulgated,andshalltakeeffectasofJune1,2016.


Director BiJingquan

DirectorLiBin

March1,2016

GoodClinicalPracticeforMedicalDevices

Chapter1Generalprovisions

Article1ThePracticeisformulatedinaccordancewiththeRegulationsontheSupervisionandAdministrationofMedicalDevicesinordertofurtherstrengthenthemanagementofclinicaltrialsofmedicaldevices,protecttherightsandbenefitsoftrialsubjectsandassuretheclinicaltrialprocedurestandard,truthful,scientific,reliableandtraceable.

Article2AlltheclinicaltrialsofmedicaldeviceswithintheterritoryofthePeople'sRepublicofChinashallbeconductedaccordingtothepractice.ThePracticecoversthewholeprocedureofclinicaltrialofmedicaldevices,includingtheprotocoldesign,conduction,monitoring,audit,inspection,collectionofdata,record,analysisandsummaryandreportofclinicaltrial,etc.

Article3ClinicaltrialofmedicaldevicesmentionedinthisPracticereferstotheprocessofconfirmingandverifyingthesafetyandefficacyofthemedicaldeviceintendedtoapplyregistrationundernormalconditioninqualifiedclinicaltrialinstitutionsofmedicaldevices.

Article4Clinicaltrialsofmedicaldevicesshallcomplywiththeprincipleoflegal,ethicandscience.

Article5Foodanddrugregulatoryauthorityaboveprovincelevelareresponsibleforthesupervisionandmanagementofclinicaltrailsofmedicaldevices.

ThecompetentdepartmentofNationalHealthandFamilyPlanningCommissionshallstrengthenthemanagementofclinicaltrailsofmedicaldeviceswithin the scope of its duties.

FoodanddrugregulatoryauthorityandthecompetentdepartmentofNHFPCshallestablishtheinformationnotificationsystemonqualitymanagementofmedicaldeviceclinicaltrialsandstrengthentheinformationnotificationontheapprovalforconductingclinicaltrialofClassIIImedicaldevicesandthemedicaldeviceslistedinthemanagementcatalogoflarge medical equipmentcollocation in Chinaandthedataofthesupervisionandmanagementonrelevantclinicaltrial.

ChapterIIPreparationbeforeclinicaltrials

Article6Thereshouldbesufficientscientificbasisandcleartrialpurposetoconductclinicaltrialsofmedicaldevices,andtheexpectedbenefitsandriskstothehealthofsubjectsandpublicshallbeweighed,theexpectedbenefitsshouldexceedthepossibledamage.

Article7Beforeclinicaltrial,thesponsorshallcompletethepre-clinicalstudyofinvestigationalmedicaldevices,includingthedesignofproducts（structureandcomposition,workingprincipleandmechanismofaction,intendeduse,applicationscopeandapplicabletechnicalrequirements）andqualityinspection,animaltrialandanalysisreport,etc,andtheresultsshallsupporttheclinicaltrial.Theresultsofqualityinspectionincludereportofself-inspectionandthequalifiedreportforregistrationinspectionissuedbyaqualifiedinspectionagencywithinoneyear.

Article8Beforeclinicaltrial,thesponsorshallprepareadequateinvestigationalmedicaldevices.Thedevelopmentofinvestigationalmedicaldevicesshallmeetrelevantrequirementsofqualitymanagementsystemofmedicaldevices.

Article9Clinicaltrialsofmedicaldevicesshallbeconductedintwoormorethantwoclinicaltrialinstitutionsofmedicaldevices.Theselectedtrailinstitutionshallbequalifiedclinicaltrialinstitutionofmedicaldevicesandthefacilitiesandconditionsshallmeettherequirementsforconductingclinicaltrialssafelyandeffectively.Theinvestigatorshouldhavetheprofessionalexpertise,qualificationsandabilitytoundertaketheclinicaltrialandshouldhavebeentrained.

Administrativemeasuresforthequalification recognitionofclinicaltrialinstitutionsofmedicaldevices shall be formulated separately byChinaFoodandDrugAdministrationandNationalHealthandFamilyPlanningCommissionofChina.

Article10Beforeclinicaltrial,thesponsor,clinicaltrialinstitutionandinvestigatorshallmakea written agreementontrialdesign,qualitycontroloftrial,divisionofresponsibilitiesinthetrial,thecostofclinicaltrialsundertakenbythesponsorandthetreatmentprincipleofinjuriesthatmayoccurinthetrial.

Article11Clinicaltrialsshouldbeapprovedbyethicscommitteeofclinicaltrialinstitutions.MedicaldeviceslistedinthedirectoryofClassIIImedicaldeviceclinicaltrialshallalsobeapprovedbyCFDA.

Article12Beforeclinicaltrial,thesponsorshouldfiletolocalfoodanddrugregulatoryauthorityoftheprovince,theautonomousregionorthemunicipalitydirectlyundertheCentralGovernment.

ThefoodanddrugregulatoryauthorityacceptingthefillingshouldreportthefilingsituationstothefoodanddrugregulatoryauthorityandthecompetentauthorityofNHFPCinthesamelevelwheretheclinicaltrialinstitutionislocated.

ChapterIIIProtectionofrightsandbenefitsoftrialsubjects

Article13ClinicaltrialsofmedicaldevicesshouldbeconductedinaccordancewiththeethicalprinciplesinWorldMedicalAssociationDeclarationofHelsinki.

Article14Ethicalreviewandinformedconsentarethemainmeasurestoprotecttherightsandbenefitsofsubjects.Eachpartyinvolvedintheclinicaltrialshallundertakecorrespondingethicalresponsibilitiesaccordingtotheirdutiesinthetrial.

Article15Thesponsorshouldavoidtocauseundueinfluenceormisleadingtosubjects,clinicaltrialinstitutionsandtheinvestigatorandotherclinicaltrialparticipantsorrelatedparties.

Clinicaltrialinstitutionandtheinvestigatorshouldavoidtocauseundueinfluenceandmisleadingtosubjects,thesponsorandotherclinicaltrialparticipantsorrelatedparties.

Article16Thesponsor,clinicaltrialinstitutionandtheinvestigatorshallnotexaggeratethecompensationmeasuresforparticipatinginclinicaltrialsandmisleadthesubjectstoparticipateinclinicaltrials.

Article17Beforeclinicaltrial,thesponsorshallsubmitthefollowingdocumentstoethicscommitteethroughtheinvestigatorandthemanagementdepartmentofmedicaldeviceclinicaltrialofclinicaltrialinstitution:

（1）Protocolofclinicaltrial;

（2）Investigator’sbrochure;

（3）Textofinformedconsentformandanyotherwrittendocumentsprovidedtosubjects;

（4）Procedural documentsforrecruitingsubjectsandpublicity;

（5）Textofcasereportform;

（6）Self-inspectionreportandtheinspectionreportforproductregistration;

（7）Resumes,professionalexpertise,ability,trainingoftheinvestigatorandotherdocumentstoprovequalifications;

（8）Overviewofthefacilitiesandconditionsofclinicaltrialinstitutionmeetingtrial;

（9）Declarationthatthedevelopmentofinvestigationalmedicaldevicesmeetrelevantrequirementsofapplicablequalitymanagementsystemofmedicaldevices;

（10）Otherdocumentsrelatedtoethicalreview.

Ethicscommitteeshouldupholdtheprinciplesofethicsandscience,reviewandsupervisetheimplementationofclinicaltrials.

Article18Ifoneofthefollowingcasesoccurduringtheclinicaltrial,theinvestigatorshallreportintimetothemanagementdepartmentofmedicaldeviceclinicaltrialofclinicaltrialinstitution,informthesponsorandreporttheethicscommitteethroughthemanagementdepartment:

（1）Seriousadverseevents;

（2）Reportofprogress,includingsummaryforsafetyandreportofdeviation;

（3）Foranyrevisefortheapproveddocumentsbyethicscommittee,thenonsubstantivechangesthatdonotaffecttherightsandbenefits,safetyandhealthofsubjectsorisnotrelatedtothepurposeorendpointofclinicaltrialdon’tneedtobereportedinadvance,butshallbenotifiedinwrittenformafterwards.

（4）Suspension,terminationorrequiringforrestoringtheclinicaltrialaftersuspension;

（5）deviationofclinicaltrialprotocolaffectingtherightsandbenefits,safetyandhealthofsubjectsorthescientific nature.

Inordertoprotecttherightsandbenefits,safetyandhealthofsubjects,thedeviationinanemergencythatcan’tbereportedintimeshallbereportedassoonaspossibleinwrittenformafterwardsaccordingtorelevantprovisions.

Article19Intheprocessofclinicaltrial,inthecastthatrevisingtheclinicaltrialprotocol,informedconsentformandotherdocuments,requiringfordeviationandrestoringthesuspendedclinicaltrial,thetrialshallcontinuetobeimplementedafterbeingapprovedbytheethicscommittee.

Article20Theminors,pregnantwomen,oldpeople,personswithmentaldisability,patientsindangerandothersshallbeavoidedtobechosenassubjects;iftheyareneededtobechosenforsomenecessaryreason,relevantadditionalrequirementsprovidedbytheethicscommitteeshallbecompliedwith,andthespecialdesignshallbeconductedfortheirhealthconditionsintheclinicaltrialanditshallbehelpfultotheirhealth.

Article21Beforethesubjects’participatingintheclinicaltrial,theinvestigatorshallexplainthedetailsofclinicaltrialtothesubjects,the guardians of persons without or with limited capacity for civilconduct,includingrecognized,foreseeablerisksandpossibleadverseevents,etc.Thesubjectsandguardiansshallsigntheirnameandthedateontheinformedconsentformaftersufficientanddetainedexplanation,andtheinvestigatorshallalsoneedtosignhisnameandthedate.

Article22Thefollowingcontentsandexplanationso