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1、—1—AnnexTechnicalGuidelinesfClinicalAppraisalofMedicalDevicesⅠDraftingobjectiveClinicalappraisalofmedicaldevicesistheprocessimplementedbyregistrationapplicanttoidentifywhethertheproductfulfillsusagerequirementsapplicatio

2、nscopeaccdingtoinfmationconcerningclinicaldocumentsclinicalexperiencesdataclinicaltrialssoon.Thisguidelinesisintendedtoprovidetechnicalguidefregistrationapplicanttocarryoutclinicalappraisalaswellasfthefooddrugadministrat

3、ionauthitiestoreviewclinicalappraisaldocuments.ⅡLawsregulationsbasis(Ⅰ)“Medicaldevicesmanagementregulations”No.650decreeofthestatecouncil(Ⅱ)“Medicaldevicesregistrationmanagementspecifications”No.4decreeofthestatecouncil(

4、Ⅲ)Relevantspecificationsfclinicaltrialqualitymanagementofmedicaldevices.ⅢApplicationscopeThisguidelinesisapplicabletoclinicalappraisalofclassⅡclassⅢmedicaldeviceswhentheyareappliedfregistration.Itisnotapplicabletoclinica

5、lappraisalofinvitrodiagnostic(IVD)reagentsadministratedasmedicaldevices.Ifthereisclinicalappraisaltechnicalguidelinesfspecificproductthecrespondingclinicalappraisalshouldfollowrelevantrequirementsofit.ⅣBasicprincipleClin

6、icalappraisalshouldbecomprehensiveaswellasobjectivecrespondingdatashouldbecollectedbyvariousmeanssuchasclinicaltrials—3—includedinthe“catalogue“whichhavealreadyacquireddomesticregistrationpermission.Comparisonexplanation

7、shouldinclude“Comparisonfmfdeclaredproductthemedicaldevicesinthe“catalogue“whichhasalreadyacquireddomesticregistrationpermission“(refertoannex1)crespondingsupptivedocuments.Theabovementionedsubmitteddocumentsshouldprovet

8、heequivalencebetweendeclaredproducttheproductlistedinthe“catalogue“.Ifequivalencebetweendeclaredproducttheproductlistedinthe“catalogue“cannotbeprovedcrespondingjobsshouldbecarriedoutaccdingtootherrequirementsinthisguidel

9、ines.Ⅵ.Requirementsfanalysisappraisalwithdatafromclinicaltrialclinicaluseofthesamevarietymedicaldevices.(Ⅰ)Thesamevarietymedicaldevices1DefinitionofthesamevarietymedicaldevicesThesamevarietymedicaldevicesarethedomesticre

10、gisteredproductswhichareidenticaltothedeclaredproductintheaspectsofbasicprinciplestructurecompositionmanufacturingmaterial(itrefertothemanufacturingmaterialincontactwithhumanbodyfactiveproducts)manufacturingtechnologyper

11、fmancerequirementssafetyappraisalimplementednationalprofessionalstardsintendedapplicationsoon.Ifthedifferencebetweendeclaredproductthesamevarietymedicaldeviceshasnoadverseinfluenceonproductsafetyeffectivenesstheycanbejud

12、gedasbasicequivalent.2.JudgmentofthesamevarietymedicaldevicesWhenanalysisappraisalisimplementedwithdatafromclinicaltrialclinicaluseofthesamevarietymedicaldevicestoprovethesafetyeffectivenessofmedicaldevicesregistrationap

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