Requirements-for-registration-files-of-medical-dev

Appendix1RegistrationCertificateforMedicalDeviceofPeople'sRepublicofChina(Format)RegistrationCertificateNo:NameofApplicantAddressofApplicantManufacturingAddressAgentName(ForImportedMedicalDevice)AddressofAgent(ForImportedMedicalDevice)ProductNameModel/SpecificationStructureandCompositionScopeofapplicationAppendixProductTechnicalRequirementOthercontentsRemarkApprovedby(Department):DateofApproval:YYYY/MM/DDDateofExpiry:YYYY/MM/DD(SealofEvaluationandApprovalDepartment)Appendix2PermissionofchangetoregistrationformedicaldeviceofPeople'sRepublicofChina(Format)RegistrationNo.：ProductNameChangeContents“***(originalregistrationcontentoritem)ischangedto***(changedcontent).RemarkThepermitisusedinconjunctionwiththeregistrationcertificate“”Approvedby(Department):DateofApproval:YYYY/MM/DD(SealofEvaluationandApprovalDepartment)—3——Appendix3CFDAApprovalforMedicalDeviceClinicalTrial(Format)ApprovalNo.:NameofApplicantAddressofApplicantNameofInvestigationalMedicalDeviceModelandSpecificationofInvestigationalMedicalDeviceStructureandCompositionofInvestigationalMedicalDeviceEvaluationandApprovalCommentsSendtoCopytoRemarkApprovedby(Department):DateofApproval:YYYY/MM/DD(SealofEvaluationandApprovalDepartment)—4——Appendix4RequirementsandInstructionsforMedicalDeviceRegistrationApplicationlevelIheadlinesofapplicationdossierlevelIIheadlinesofapplicationdossier1.Applicationform2.Supportingdocuments3.Listofbasicrequirementsforsafetyandeffectivenessofmedicaldevice4.Summary4.1Overview4.2Productdescription4.3Modelandspecification4.4Packinginstructions4.5Applicablescopeandcontraindications4.6Referencedclinicaldataofproductsofsamekindoritspredecessors(ifany)4.7Othercontentstobespecified5.ResearchInformation5.1Productperformancestudy5.2Evaluationstudyonbiocompatibility5.3Biologicalsafetystudy5.4Sterilization/disinfectionprocessstudy5.5Studyonshelflifeandpackaging5.6Animalstudy5.7Softwarestudy5.8Others6.Manufacturinginformation6.1Informationdescriptionofthemanufacturingprocessofnon-active/activeproducts6.2Manufacturingsite7.Clinicalevaluationmaterial8.Riskanalysismaterialof—5——products9.Producttechnicalrequirement10.ProductType-testingreport10.1Type-testingreport10.2pre-assessmentadviceonProducttechnicalrequirement11.Samplesofinstructionforuseandlabel11.1Instructionforuse11.2Labelsamplesofminimumsalesunit12.ConformitystatementTheapplicationdossiershallhaveanindexwhichcoversalllevelIandlevelIIheadlines,andseparatelycompilepagenumberforthecorrespondinginformationtoeachlevelIIheadline.I.ApplicationformII.Supportingdocuments(I)Domesticapplicantshallprovide:1.Copiesofbusinesslicenseandorganizationcodecertificate2.WhenapplyingforregistrationofdomesticmedicaldevicesaccordingtoSpecialProcedureofApprovalandEvaluationforInnovativeMedicalDevices,applicantshallprovideanoticeofapplicationforreviewing“Specialprocedureofapprovalandevaluationforinnovativemedicaldevices”,andifthesampleproductsareproducedbyentrustedmanufacturers,manufacturinglicenseoftheentrustedmanufacturerandconsignmentagreementshallbeprovided.Thescopeofmanufacturinglicenseshallcoverthecategoryofthesubmittedproducts.(II)ImportedMedicalDeviceapplicantshallprovide:(1)Supportingdocumentsofmarketingauthorizationorcertificateoftheproductissuedbyauthorityofthecountry(orregion)wheretheapplicant’sheadquarterormanufacturingsiteislocated,andtheauthorization/qualificationdocumentsoftheenterprise.—6——(2)Iftheproductisnotmanagedasamedicaldevicebyauthorityofthecountry(orregion)wheretheImportedmedicaldeviceapplicantislocated,applicantshallproviderelevantsupportingdocuments,includingsupportingdocumentsofmarketingauthorizationandquantificationcertificateofmanufacturerissuedbyauthorityofthecountry(orregion)wheretheregistrationofficeormanufacturingsiteislocated.(3)PowerofattorneyoftheforeignapplicantfordesignatingagentinChina,copiesoftheletterofcommitmentandbusinesslicenseorcopyoforganizationregistrationcertificateofagent.III.ListofbasicrequirementsforsafetyandeffectivenessofmedicaldeviceThelistisadocumentdescribingthattheproductcomplieswithmethodsusedinallapplicablerequirementsoftheListforBasicRequirementsforSafetyandEffectivenessofMedicalDevice(seeAppendix8)andprovingitsconformity.ThereasonsshallbegivenforallinapplicablerequirementsintheListforBasicRequirementsforSafetyandEffectivenessofMedicalDevice.Fordocumentsincludedinapplicationdossier,theirspecificlocationsinthedossiershallbeprovided;forthosenotincludedinapplicationdossier,thenameofdocumentaryevidenceanditsdocumentnumberinQMSshallbenoted.IV.Summary(I)OverviewDescribethemanagementcategory,criteriafordeterminingtheclassificationcodeanddevicenameoftheproduct(II)Productdescription1.Non-activemedicaldevices—7——Describetheproduct’soperationprinciple,mechanismofoperation(ifapplicable),structure&composition(includingsupportingaccessories),mainrawmaterialsanddifferentfeatureswithotherproductsofsamekind;andgraphicorchartswithexplanationshallbeprovidedasnecessary.2.ActivemedicaldevicesDescribetheproduct’soperationprinciple,mechanismofoperation(ifapplicable),structu