2015年医疗器械临床评价技术指导原则(英文版)

—1—AnnexTechnicalGuidelinesforClinicalAppraisalofMedicalDevicesⅠDraftingobjectiveClinicalappraisalofmedicaldevicesistheprocessimplementedbyregistrationapplicanttoidentifywhethertheproductfulfillsusagerequirementsandapplicationscopeaccordingtoinformationconcerningclinicaldocuments,clinicalexperiencesdata,clinicaltrialsandsoon.Thisguidelinesisintendedtoprovidetechnicalguideforregistrationapplicanttocarryoutclinicalappraisalaswellasforthefoodanddrugadministrationauthoritiestoreviewclinicalappraisaldocuments.ⅡLawsandregulationsbasis(Ⅰ)“Medicaldevicesmanagementregulations”No.650decreeofthestatecouncil;(Ⅱ)“Medicaldevicesregistrationmanagementspecifications”No.4decreeofthestatecouncil;(Ⅲ)Relevantspecificationsforclinicaltrialqualitymanagementofmedicaldevices.ⅢApplicationscopeThisguidelinesisapplicabletoclinicalappraisalofclassⅡandclassⅢmedicaldeviceswhentheyareappliedforregistration.Itisnotapplicabletoclinicalappraisalofinvitrodiagnostic(IVD)reagentsadministratedasmedicaldevices.Ifthereisclinicalappraisaltechnicalguidelinesforspecificproduct,thecorrespondingclinicalappraisalshouldfollowrelevantrequirementsofit.ⅣBasicprincipleClinicalappraisalshouldbecomprehensiveaswellasobjectiveandcorrespondingdatashouldbecollectedbyvariousmeanssuchasclinicaltrialsand—2—soon.Clinicalperformanceandsafetydatacollectedinclinicalappraisalprocessshouldbeincludedinanalysisnomatteritispositiveornegative.Clinicalappraisaldepthandscopeaswellasdatatypeanddataquantityrequiredshouldbecompatiblewithdesignfeature,keytechnology,applicationscopeandriskleveloftheproductwhiletheyshouldbealsocompatiblewithlevelanddegreeofnon-clinicalresearch.Clinicalappraisalshouldconfirmclinicalapplicationinformationconcerningapplicationscope(suchasapplicablepeople,applicableparts,contactmannerwithhumanbody,indications,diseaselevelandstage,applicationrequirementsandapplicationenvironment,etc),usemethod,contraindications,preventionmeasuresandwarning,etc.Registrationapplicantshoulddrawthefollowingconclusionthroughclinicalappraisal:theproducthastheexpectedperformanceinnormaluse;theriskofproductisacceptablecomparedwithexpectedbenefits;theclinicalperformanceandsafetyofproductarebothsupportedbyproperevidences.Ⅴ.Clinicalappraisalrequirementsfortheproductlistedincatalogueofmedicaldevicesexemptedfromclinicaltrial.FortheproductlistedinCatalogueofmedicaldevicesexemptedfromclinicaltrial,registrationapplicantneedstosubmitdocumentsofcomparisonbetweenrelevantinformationofdeclaredproductandthecontentincludedinthecatalogueaswellascomparisonexplanationfordeclaredproductandthemedicaldevicesincludedinthecataloguewhichhavealreadyacquireddomesticregistrationpermission.Thespecificclinicalappraisaldocumentsrequiredtobesubmittedisasfollows:(Ⅰ)Submitdocumentsofcomparisonbetweenrelevantinformationofdeclaredproductandthecontentincludedincatalogue;(Ⅱ)Submitcomparisonexplanationfordeclaredproductandthemedicaldevices—3—includedinthecataloguewhichhavealreadyacquireddomesticregistrationpermission.ComparisonexplanationshouldincludeComparisonformfordeclaredproductandthemedicaldevicesinthecataloguewhichhasalreadyacquireddomesticregistrationpermission(refertoannex1)andcorrespondingsupportivedocuments.Theabove-mentionedsubmitteddocumentsshouldprovetheequivalencebetweendeclaredproductandtheproductlistedinthecatalogue.Ifequivalencebetweendeclaredproductandtheproductlistedinthecataloguecannotbeproved,correspondingjobsshouldbecarriedoutaccordingtootherrequirementsinthisguidelines.Ⅵ.Requirementsforanalysisandappraisalwithdatafromclinicaltrialandclinicaluseofthesamevarietymedicaldevices.(Ⅰ)Thesamevarietymedicaldevices1DefinitionofthesamevarietymedicaldevicesThesamevarietymedicaldevicesarethedomesticregisteredproductswhichareidenticaltothedeclaredproductintheaspectsofbasicprinciple,structurecomposition,manufacturingmaterial(itrefertothemanufacturingmaterialincontactwithhumanbodyforactiveproducts),manufacturingtechnology,performancerequirements,safetyappraisal,implementednational/professionalstandards,intendedapplicationandsoon.Ifthedifferencebetweendeclaredproductandthesamevarietymedicaldeviceshasnoadverseinfluenceonproductsafetyandeffectiveness,theycanbejudgedasbasicequivalent.2.JudgmentofthesamevarietymedicaldevicesWhenanalysisandappraisalisimplementedwithdatafromclinicaltrialandclinicaluseofthesamevarietymedicaldevicestoprovethesafetyandeffectivenessofmedicaldevices,registrationapplicantshouldcomparethedeclaredproductwithoneorseveralmedicaldevicesofthesamevarietytoprove—4—theequivalenceofthem.Theitemsforcomparisonwiththesamevarietymedicaldevicesshouldincludebutnotlimittotheitemsinannex2.Thecomparisoncontentincludesqualitativeandquantitativedata,verifyingandconfirmingresult.Homogenyanddifferencesbetweenbothofthemshouldbedescribedindetailswhileitshouldbeverifiedand/ordeterminedwhetherthereisadverseinfluenceonproductsafetyandeffectivenessduetodifferencebyusingthedataofdeclaredproductitself,suchasnonclinicalresearchdataofthedeclaredproduct,clinicaldocumentsdata,clinicalexperiencesdataanddataofclinicaltrialimp