《医疗器械临床试验质量管理规范》英文版

《医疗器械临床试验质量管理规范》英文版StateFoodandDrugAdministration

NationalHealthandFamilyPlanningCommission

Numbertwenty-fifth

<medicalequipmentspecificationforthequalitycontrolofclinicaltrialof>hasbeenstatefoodandDrugAdministrationintheexecutivemeetingofthe,nationalhealthandFamilyPlanningCommission,directorofthecommitteemeetingexaminedandadopted,isherebypromulgated,sinceJune1,2016implementation.

DirectorBiJingquan

DirectorLiBin

March1,2016

Standardforqualitymanagementofmedicaldeviceclinicaltrials

Chapteroneisthefirstchapter

Thefirstistostrengthenthemanagementofmedicaldeviceclinicaltrials,themaintenanceprocessforclinicaltrialsofmedicaldevicesinrightsandinterests,andtoguaranteethemedicaldeviceclinicaltrialsprocessspecification,realresults,science,reliableandtraceable,accordingto<thesupervisionandadministrationofMedicalDevicesRegulations>formulatedthisspecification.

Article2withintheterritoryofthepeople'sRepublicofChinatocarryouttheclinicaltrialofmedicalapparatusandinstruments,shallcomplywiththespecification.Thisspecificationcoversthewholeprocessofmedicaldeviceclinicaltrials,includingdesignofclinicaltrials,theimplementationof,monitoring,verification,inspection,anddataacquisition,record,andanalyzethesummarizingandreporting.

Thethirdsectionofthisspecificationreferredtointheclinicaltrialofmedicalapparatusandinstruments,referstointheaccreditationofmedicalinstrumentclinicaltrialinstitution,intendstoapplyfortheregistrationofmedicaldeviceinthenormalconditionsofuseissafeandeffectiveforconfirmationorverificationprocess.

Fourthclinicaltrialsofmedicaldevicesshallcomplywiththeprinciplesoflaw,ethicalprinciplesandscientificprinciples.

Article5atorabovetheprovinciallevelfoodanddrugsupervisionandmanagementdepartmentsresponsibleforthesupervisionandmanagementofmedicaldeviceclinicaltrials.Healthandfamilyhealthdepartmentincharge,withinitsscopeoffunctionsandduties,strengthentheclinicaltrialofmedicalapparatusandinstrumentsmanagement.Foodanddrugsupervisionandmanagementdepartments,healthandfamilyhealthdepartmentsshouldestablishthemedicalqualityofclinicaltrialmanagementinformationreportingmechanism,strengthentheclassIIImedicaldevices,includedinthenationalconfigurationoflargemedicalequipmentqualitymanagementobjectiveofmedicalapparatusandinstrumentstocarryoutexaminationandapprovalofclinicaltrialsandthecorrespondingclinicaltrialsupervisionandmanagementofdatacommunications.

Thesecondchapteristhepreparationbeforeclinicaltrial

Article6theclinicaltrialofmedicalapparatusandinstrumentsshallhavesufficientscientificbasisandtheclearpurposeofthetest,andweighonexpectedandthepublichealthbenefitandrisk,expectedbenefitshouldexceedthepossibledamage.

Article7beforeclinicaltrials,thesponsorshalltestdoneinpreclinicalstudiesofmedicalapparatusandinstruments,includingproductdesign(structure,workingprincipleandmechanismofaction,isexpectedtouseandscopeofapplication,theapplicabletechnicalrequirementsandqualityinspection,animaltestingandriskanalysisandresultsshouldbeabletosupporttheclinicaltrial.Qualityinspectionresultsincludingselfinspectionreportandaqualifiedinspectionagencyissuedayearwithintheproductregistrationinspectionreport.

Priortotheeighthclinicaltrials,theapplicantshouldprepareadequatetestingofmedicalequipment.Thedevelopmentofthetestwithmedicalequipmentshallmeettheapplicablerequirementsofthemedicaldevicequalitymanagementsystem.

Thenineclinicaltrialsofmedicaldevicesshallbeintwoormorethantwomedicaldeviceclinicaltrialinstitution.Selectedtestinginstitutionsshallbewithoutqualificationaccreditationofmedicalinstrumentclinicaltrialinstitution,andfacilitiesandconditionsshallmeetthesafetyeffectivelyclinicaltrialexperience.Researchersshouldbeabletobeartheclinicaltrialsofspecialty,qualificationandabilityandtrained.QualificationofmedicalinstrumentclinicaltrialinstitutionidentifiedmanagementmeasuresshallbeformulatedseparatelybytheStateFoodanddrugadministrationshall,jointlywiththeMinistryofhealthandFamilyPlanningCommission.

Article10beforeclinicaltrials,thesponsorandclinicaltrialinstitutionsandresearchersshouldtestdesign,testqualitycontrol,testthedivisionofresponsibilities,sponsortobearthecostsassociatedwiththeclinicaltrialandtestinmayoccurdamagedealingwithprinciplestoreachawrittenagreement.Article11clinicaltrialsshouldobtainconsentoftheclinicaltrialofmedicalapparatusandinstrumentsinstitutionalethicscommittee.IncludedintheneedforclinicaltrialsandapprovalofclassIIImedicaldevicesdirectory,shouldalsobeapprovedbytheStateFoodanddrugadministration.

Article12priortoclinicaltrials,thesponsorshallbetothelocationofprovinces,autonomousregions,municipalfoodanddrugsupervisionandmanagementdepartmentsfortherecord.Acceptfilingoffoodanddrugsupervisionandadministrationdepartmentshallrecordthesituationinformedclinicaltrialinstitutionislocatedatthesameleveloffoodanddrugsupervisionandmanagementdepartments,aswellashealthandfamilyhealthdepartments.

Thethirdchapteristheprotectionoftherightsandinterestsofthesubjects

ThirteenthclinicaltrialsofmedicaldevicesshallcomplywiththeethicalstandardssetbytheHelsinkideclarationoftheworldmedicalassembly.

Thefourteenthethicalreviewandinformedconsentarethemainmeasurestoprotecttherightsandinterestsofthesubjects.Thepartiesinvolvedinclinicaltrialsshouldassumethecorrespondingethicalresponsibilitiesaccordingtotheirrespectiveresponsibilities.

Article15thesponsorshouldavoidundueinfluenceormisleadingtosubjects,clinicaltrialsandresearchandclinicaltrialparticipantsorrelatedparty.Clinicaltrialinstitutionsandresearchersshouldavoidundueinfluenceormisleadingtosubjects,thesponsorandotherparticipantsinclinicaltrialsorinterestedparties.

Sixteenthapplicants,clinicaltrialsandresearchersshouldnotexaggeratethecompensationmeasuresinvolvedinclinicaltrials,tomisleadtheparticipantstoparticipateinclinicaltrials.

Seventeenthpreclinicaltrials,theapplicantshallsubmitthefollowingdocumentstotheethicscommitteebyresearchersandclinicaltrialinstitutionofmedicalinstrumentclinicaltrialmanagement:(a)clinicaltrialprogram;(two)researchersmanual;(three)writteninformedconsentdocumentandanyotheravailabletoparticipants(;four)recruitingsubjectsandproceduraldocumentstoitspropaganda;(five)thecasereportformtext;(six)selfinspectionreportandproductregistrationinspectionreport;(seven)researchersresume,professionalexpertise,skills,trainingandotherdocumentstoprovetheirqualifications;(eight)clinicaltrialinstitutionthefacilitiesandconditionstomeetthetestreview;(nine)withthedevelopmentofmedicaldevicesinaccordancewiththerelevantrequirementsofmedicalqualitymanagementsystemfortheteststatement;(ten)otherdocumentsrelatedtoethicalreview.Ethicscommitteeshallupholdtheprinciplesofethicsandscience,reviewandsupervisetheimplementationofclinicaltrials.

Eighteenthoneofthefollowingcircumstancesoccurinthecourseofclinicaltrials,researchersshouldreporttotheclinicaltrialinstitutionofmedicalinstrumentclinicaltrialmanagementdepartment,andthetimelynotificationoftheapplicant,theethicscommitteereport:(a)seriousadverseevents;(two)progressreport,includingasummaryofsafetyanddeviationreports;(three)foranyamendmenthasbeenapprovedbytheethicscommitteeofthefile,doesnotaffecttherightsandinterestsofthesubjects,safetyandhealth,nonsubstantivechangeswithoutpriorreportsorclinicaltrialswiththepurposeorendnotrelated,butafterwardsshallnotifyinwriting;(four)tosuspend,terminateorsuspendtherequestaftertherecoveryofclinicaltrials(five;)affecttherightsandinterestsofthesubjects,fromclinicaltrialsorclinicaltrialsafetyandhealthscience,includingthedeviationofrequestandreportthedeviation.FortheprotectionofsubjectsWhereaperson'srights,securityandhealtharenotimmediatelyreportedinanemergency,itshallbereportedinwrittenformassoonaspossibleinaccordancewiththerelevantprovisions.

Article19intheprocessofclinicaltrials,asamendedclinicaltrialprotocolsandinformedconsentdocuments,requestdeviation,resumeapausedclinicaltrialsshouldbecancontinuetoimplementuntilitobtainthewrittenapprovaloftheethicscommittee.

Itisgoodtothehealtharticle20shouldbeavoidedasfaraspossibleselectionofminors,pregnantwomen,elderly,personswithmentalobstacleinlifecriticalpatientsassubjects,thatreallyneedtobeselected,itshallabidebytheethicscommitteeoftheadditionalrequirement.Inclinicaltrialsfortheirhealthisspeciallydesigned,andshouldbe.article20shouldbeavoidedasfaraspossibleselectionofminors,pregnantwomen,elderly,personswithmentalobstacleinlifecriticalpatientsassubjects,thatreallyneedtobeselected,itshallabidebytheethicscommitteeoftheadditionalrequirement.Inclinicaltrialsfortheirhealthisspeciallydesigned,andshouldbe.

Article21insubjectsinclinicaltrials,researchersshouldfullytosubjectsornocapacityforcivilconduct,theguardianofthepersonofcivilactioncompetencelimitthatthedetailsoftheclinicaltrials,includingtheknown,itcanbepredictedtheriskandpossibleadverseevents.AfterfullanddetailedexplanationbythesubjectsortheirguardiansininformedconsentBooksignyournameanddate,researchersalsoneedtoininformedconsentBooksignyournameanddate.

Twenty-secondgeneralconsentshallincludethefollowingcontentsanddescriptionofmatters:(a)theresearchersnameandrelevantinformation;(two)thenameofclinicaltrialinstitution;(three)thenameofthetrial,purpose,method,content;(four)testprocess,testperiod;(five)thesourcesoffundsandthepossibleconflictsofinterest;(six)theexpectedparticipantsmaybenefitandknown,riskcanbeforeseenandadverseeventsmayoccur;(seven)alternativetreatmentsubjectscanobtaintheinformationanditspotentialbenefitsandrisks;(eight)whenneeded,thatsubjectsmaybeassignedtodifferentgroupsofexperiments;(nine)subjectsparticipatedintheexperimentshouldbevoluntary,andatanystageofthetesthastherighttowithdrawwithoutdiscriminationorrevenge,themedicaltreatmentandTherightsandinterestsarenotaffected;(ten)toldthesubjectsinthestudyofpersonaldataisconfidential,buttheethicscommittee,foodanddrugsupervisionandmanagementdepartments,healthdepartmentsorsponsoratworkwhennecessaryinaccordancewiththeprescribedprocedures,canrefertothesubjectsinthestudyofpersonaldata;(eleven)ashappenedwiththerelatedtestthehurt,thesubjectscouldgettreatmentandeconomiccompensation;(twelve)thesubjectscanunderstandtherelatedinformationduringthetest;(thirteen)freeclinicprojectparticipantsmaybeobtainedduringthetestandotherrelatedsubsidies.Informedconsentshallbeadoptedbythesubjectsorguardianscanunderstandthelanguageandtext.Informedconsentshallnotcontainanycausesubjectstogiveupthelegitimaterightsandinterestsandexemptionfromclinicaltrialinstitutionsandresearchers,thesponsororTheagentshallberesponsibleforthecontent.

Twenty-thirdobtaininformedconsentshallalsomeetthefollowingrequirements:(a)thesubjectsincapacitated,iftheethicscommitteeagreedinprinciple,researchersbelievethatthesubjectsparticipatinginaclinicaltrialwithitsowninterests,canalsoenterclinicaltrials,butshouldtryandmarkedbytheGuardianSignatureDateprior.;(two)thesubjectsortheirguardianswithoutreadingability,intheprocessofknowledgeshouldhaveawitnesspresent,afteradetailedexplanationoftheinformedconsent,witnessesreadtheinformedconsentandoralinformedcontent,agreedtobythesubjectsortheircarepopulationhead,witnessesininformedconsentthebookofsignatureanddate,signatureofwitnessandtheresearcher'ssignatureshouldbeonthesameday.;(three)minorsassubjects,shouldobtaintheconsentoftheguardianandsignedinformedconsentDepartmentinformedconsent,minorsonwhethertoparticipateintestinganintention,shouldalsobetheirconsent.;(IV)foundrelatestomedicalapparatusandinstrumentsofimportantinformationorareexpectedtotesttheclinicalimpactofshallbeofinformedconsentbookcontentismodified,themodifiedinformedconsentbytheethicscommitteeapprovalshallbebythetestoritsguardianresignatureconfirmation.

Article24informedconsentbookshallbeindicatedintheformulationofdateorrevisedversionsofdate.Suchasinformedconsentinthetestintheprocessofrevision,revisedversionoftheinformedconsentimplementthebookbeforeagainbytheethicscommitteeagreedto.Revisededitionofinformedconsentbooksclinicaltrialmechanismafter,allbeforetheendofthetestprocessofthesubjectswereasaffectedbytheshallsignedtheinformedconsentforthenewlyrevised.

Twenty-fifthsubjectshavetherighttowithdrawfromanystageofclinicaltrialsandarenotsubjecttoanyfinancialresponsibility.Thefourthchapterclinicaltrialprogram

Twenty-sixthtocarryoutclinicaltrialsofmedicaldevices,theapplicantshouldbeinaccordancewiththecategoriesofmedicalequipmenttesting,risk,intendeduse,andotherorganizationstodevelopscientificandrationalclinicaltrialsprogram.

Article27notinsideandoutsidetheapprovedthelistingofnewproducts,safetyandperformancehasnotbeenconfirmedbymedical,clinicaltrialdesignshouldfirstconductafeasibilitytestforsmallsamples,tobeinitiallyrecognizedfortheirsafety,accordingtothestatisticalrequirementstodeterminethesamplesizetocarryoutthefollowingclinicaltrial.

Twenty-eighthclinicaltrialsprotocolshouldincludethefollowing:(a)generalinformation;(two)thebackgrounddatainclinicaltrials;(three)thepurposeoftheexperiment;(four)experimentaldesign;(five)safetyevaluationmethod;(six)effectivenessevaluationmethod;(seven)statisticalconsiderations;(eight)theprovisionsforclinicaltrialsprogram;(nine)theprovisionsofadverseeventsandequipmentdefectreport;(ten)directaccesstothesourcedatafile;(eleven)clinicaltrialsinvolvingethicalissuesandinstructionsandinformedconsentdocument;(twelve)dataprocessingandrecordkeeping;(thirteen)financialandinsurance;(fourteen)agreement.Thetestresultswerepublishedpartofthecontentscanbeincludedinotherrelateddocumentssuchasprojectresearchers.HandbookofclinicaltrialsSpecificinformationabouttheorganization,theresultsofthetrialpublishedagreement,financeandinsurancecanbeexpressedinthetestplan,youcanalsomakeaseparateagreementtobespecified.

Twenty-ninthmulticenterclinicaltrialbyanumberofresearchersinthesametestprograminclinicaltrialsindifferentperiod.Thedesignandimplementationofthetestplanshallatleastincludethefollowingcontents:(a)thetestplanandtheclinicaltrialinstitutionsandresearcherstodiscussidentifiedbytheapplicantorganization,andaclearleadtheunitofclinicaltrialinstitutionforthecoordinationofresearchers;(two)theresearchersresponsibleforcoordinatingtheworkofcoordinationbetweentheinstitutionofclinicaltrialprocessofclinicaltrials,clinicaltrialsinearly,middleandlateorganizationresearchersmeeting,responsiblefortheimplementationandthesponsorofthewholetesttogether;(three)theinstitutionofclinicaltrialtheprincipleshouldbecarriedoutoverthesameperiodandtheendofclinicaltrials;(four)theinstitutionofclinicaltrialtestsamplesizeanddistribution,withstatisticalanalysistoForreason;(5)thesponsorandtheclinicaltestunitsonexperimentaltrainingplanandtrainingrecordsrequirements;(VI)establishedtestdatatransfer,management,queryandverificationprocedure,especiallyclearrequirementsoftheinstitutionofclinicaltrialtestingthedatashouldbetheleadunitcentralizedmanagementandanalysis;(7)aftertheendofthemulticenterclinicaltrials,eachclinicaltrialinstitutionsresearchersshouldrespectivelyissuedasummaryofclinicaltrials,togetherwithacasereporttableinaccordancewiththeprovisionsoftheauditedoverbycoordinatingresearchsummaryreport.Fifthchapterethicscommitteeduties

Article30medicaldeviceclinicaltrialinstitutionethicscommitteeshallbebyatleastfivemembers,includingmedicalprofessionals,medicalprofessionals,whichshouldbethemembersofthedifferentgender.Nonmedicalspecialtycommitteeatleastalegalworkerandanamefortheclinicaltrialinstitutionotherthanthepersonnel.Theethicscommitteeshouldbewiththeassessmentandevaluationoftheclinicaltrialsofscience,medicineandethics,andotheraspectsofqualificationorexperience.Allmembersshouldbefamiliarwithethicalguidelinesfortheclinicaltrialofmedicalapparatusandinstrumentsandrelevantregulationsandabidebytheethicscommitteeoftheconstitution.

Article31medicalethicscommitteeshallcomplywiththeprovisionsofthe<worldmedicalassemblydeclarationofHelsinki>ethicalstandardsandfoodanddrugsupervisionandadministrationdepartmentandestablishthecorrespondingworkingproceduresandtheformationofthefileandworkinaccordancewiththeproceduresperformtheirduties.Theethicscommitteeindependenttomembersoftheresearchersandthesponsorhastherighttocommentandparticipateinrelevanttestvote.

Article32TheEthicsCommitteemeetingshallbenotifiedinadvance,toparticipateinthereviewandthenumberofvotingcannotbelessthanfive,makeanydecisionshouldbebyanethicscommitteecomposedbymorethanhalfofthemembers.Researcherscanprovideinformationonanyaspectoftherelevanttest,butshouldnotparticipateinthereview,voteorcomment.Ethicscommitteeinthereviewofsomespecialtest,caninviteexpertsinrelatedfields.

Thirty-thirdfromtheethicscommitteeshallsafeguardtherightsandinterestsofthesubjectsoftheperspectiveofstrictconsiderationtestschemeandrelateddocuments,andshallfocusonthefollowing:(a)theresearchersqualifications,experienceandwhetherthereissufficienttimetoparticipateintheclinicaltrial.(two)clinicaltrialinstitutionstaffingandequipmentconformtothetest.(three)thesubjectsmaysufferadegreeofriskandbenefitcomparedtotheexpectedtestisappropriate.(four)testprogramisfullyconsideredtheethicalprinciples,withscientificresearchpurposes,includingtheappropriatenessofsubjects'rightsareprotected,otherpersonsmaysuffertheriskandprotectionmethodparticipantsarescience.(five)subjectswereselectedtotestthemethod,therelevantinformationofthesubjectsortheirguardiansprovidedTheinformationiscomplete,whetherthesubjectscouldunderstand,obtaininginformedconsentisappropriate;whennecessary,theethicscommitteeshallorganizetheparticipantsonbehalfofthelevelofunderstandingofthetestdata,theevaluationofinformedconsentisappropriate,theassessmentresultsshallbetheendofthe10yearwrittenrecordandsavetoclinicaltrials(six.)subjectsiftheoccurrenceofclinicaltrialrelatedinjuryordeath,treatmentandinsurancemeasuresforadequacy.(seven)whethertheproposedamendmentstothetestschemeisacceptable.(eight)whethercanbecarriedoutinclinicaltrialsinregularevaluationmayharmtosubjectsfrom(nine).Thetestplanmayaffecttherightsandinterestsofthesubjects,safetyandhealth,oraffectthescientificnature,theintegrityofthetest,whetheritcanbeaccepted.

Ethicalreviewthirty-fourthmulticenterclinicaltrialshouldbeledbytheethicscommitteeresponsiblefortheestablishmentofcollaborativereviewprocedurestoensureconsistencyandtimelinessofthereviewwork.Thebeginningofeachclinicaltrialinstitutionbeforethetestshouldbeledbytheethicscommitteeresponsibleforexaminationandtestschemeofethicalrationalityandscientificity,participateinthetestofotherclinicaltrialinstitutionethicstheCommitteeintheprerequisiteofacceptingtheleadunitethicscommitteereviewcomments,canbeusedtorevieworfilereview,reviewthefeasibilityofthetrialsinthisclinicaltrialinstitutions,includingthequalificationandexperienceoftheequipmentandconditions,generallynolongeronthedesignschemeofthetestproposedamendments,butnotrightapprovedtestinclinicaltrials.

Article35TheEthicsCommitteereceivestheapplicationofclinicaltrialsofmedicaldevicesshallconveneameeting,discussthereview,issueawrittenopinion,seal,andattachedtoattendthemeetingofthepersonnellist,professionalandpersonalsignature.Theviewsoftheethicscommitteemaybe:(a)consent;(II)modificationsnecessaryconsent;(III)withoutconsent;(IV),tosuspendorterminatethetesthasbeenapproved.

Article36TheEthicsCommitteeshallbeofclinicaltrialsofthisclinicaltrialinstitutiontrackingsupervision,itisfoundthatthesubjects'rightsandinterestscannotgetsecuritysituation,canbeinanytimeuponwrittenrequesttosuspendorterminatethetrial.Clinicaltrialshavebeensuspended,withouttheconsentoftheethicscommitteeshouldnotbeallowedtoresume.

Thirty-seventhethicscommitteesshallretainallrecordsrelatingtothecompletionofclinicaltrialsforatleast10years.Thesixthchapteristheresponsibilityoftheapplicant

Article38Thesponsorisresponsibleforinitiating,application,organizationandmonitoringofclinicaltrialsandtheauthenticityofclinicaltrials,responsibleforreliability.Thesponsorisusuallythemedicaldeviceproductionenterprise.Thesponsorforoverseasinstitutionsshallinaccordancewiththeprovisionswithintheterritoryofthepeople'sRepublicofChinaappointedagent.

Article39ThesponsorisresponsiblefororganizingtheformulationandrevisionoftheHandbook,theclinicaltrialsprotocol,informedconsent,casereportform,thestandardoperatingproceduresandotherrelevantdocumentsandisresponsiblefororganizingthetrainingofclinicaltrialsnecessary.

Article40thesponsorshouldaccordingtothecharacteristicsofmedicalapparatusandinstrumentsusedfortesting,intheaccreditationofmedicalinstrumentclinicaltrialinstitutionselectionmechanismtestandresearchwere.Thesponsorbeforetheclinicaltrialagreementsignedinclinicaltrialinstitutionshallclinicaltrialinstitutionsandresearcherstoprovidethelatestresearchmanualandotherrelevantdocuments,foritsdecisionwhethertheycanaffordtheclinicaltrials.

Article41themanualshallincludethefollowingmaincontents:(a)theapplicant,researchersofinformation;(II)testsummaryofmedicaldevicesfor;(III)supporttestmedicaldevicesexpectedoverviewoftheuseandclinicaltrialdesigninreasonandevaluation;and(IV)testwithmedicaldevicemanufacturingwithsuitablemedicalequipmentqualitymanagementsystemrequirementsofthestatement.

Articleforty-secondtheapplicantintheorganizationofthedevelopmentofclinicaltrialsprogrammaynotexaggeratethemechanismandefficacyofmedicaldevices.

Article43inclinicaltrials,thesponsortogetimportantinformationaboutclinicaltrialsshallmodifytheHandbookofresearchandrelateddocumentsintime,andthroughtheclinicaltrialinstitutionofmedicalinstrumentclinicaltrialmanagementdepartmentssubmitethicsreviewcommitteeagreed.

Forty-fourththeapplicantshouldwithclinicaltrialinstitutionsandresearcherstoreachawrittenagreementonthefollowingissues:(a)clinicaltrialimplementationinaccordancewiththerelevantlawsandregulationsandtheclinicaltrialprogram,andaccepttheinspection,verificationandinspection;(two)accordingtothedatarecordingandreportingprocedures;(three)retainthebasicdocumentsandtestthelessthanlessthanthestatutorytime,clinicaltrialsandresearchinstitutionsarenolongerneedtonoticeuntilthesponsorofthedocumentssofar;(four)theapplicantfromtheethicscommitteeapproval,medicalequipmentisresponsibletotheclinicaltrialinstitutionsandresearcherstoprovidetest,anddeterminetheconditionsoftransportandstorageconditions,storagetime,periodofvalidity;(five)testofmedicaldevicesshouldbequalified,itiseasytoidentify,thecorrectencodingandlabeled"test"ofthespeciallogo,andaccordingtotheclinicaltestProgramrequirementsforappropriatepackagingandpreservation;(6)theapplicantshallformulateaclinicaltrialqualitycontrolrelatedSOPs,transportationofmedicaldevicessuchastest,receiving,storage,distribution,processing,recycling,clinicaltrialsresearchorganizationsanddonorfollow.

Article45thesponsortotestwithmedicaldeviceinclinicaltrialsofthesecurityresponsibility.Whenfoundmayinfluencetestimplementationmaychangetheethicscommitteeapprovaltestcontinuesto,thesponsorshallimmediatelynotifyallclinicaltestingmachinestructureandstudytheirsafetyortest,andmakecorrespondingprocessing.

Article46thesponsordecidedtosuspensionorterminationoftheclinicaltrials,itshallnotifyallclinicaltrialinstitutionofmedicaldeviceclinicaltrialmanagementdepartmentin55days,andexplainthereasonsinwrittenform.Clinicaltrialsclinicaltrialsofmedicaldevicesmanagementdepartmentshalltimelynotifythecorrespondingresearchandethicscommittee.Thesuspensionofclinicaltrials,withouttheconsentoftheethicscommitteeandshallnotresume.A