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TÜVSÜDGreaterChinaTÜVSÜDGreaterChinaMr.YongjianSUN15-11-29RoadmapTÜVSÜDGreaterChinaMr.YongjianSUNTÜVSÜDGreaterChinaMr.YongjianSUNClassIClassIIClassIVBrazilRegistrationHolderINMETROBRHANVISAANVISAClassIIIANVISAGMPTechnicalFile/EconomicInformationReportTÜVSÜDGreaterChinaANVISATÜVSÜDGreaterChinaMr.YongjianSUNANVISANationalHealthSurveillanceAgency(AnvisaANVISAINMETROTÜVSÜDGreaterChinaMr.YongjianSUNINMETROINMETROINMETROINMETROINMETROOCP-OrganismodeCertificaçãodeProduto(ProductCertificationBodywithnumber)INMETRO.TÜVSÜDGreaterChinaMr.YongjianSUNFederalConstitutionFederalConstitutionFederalLaw(No.X.XXX)FederalLaw(No.X.XXX)Resolutions(RDCNo.XX)Resolutions(RDCNo.XX)NormativeInstructions(INNo.X)NormativeInstructions(INNo.X)Ordinances(No.XXX)Ordinances(No.XXX)TÜVSÜDGreaterChinaTÜVSÜDGreaterChinaMr.YongjianSUNGMPClassificationTÜVSÜDGreaterChinaMr.YongjianSUNMedicalDevice:RDCNo.185/200193/42/EEC18–Rule14Invasive–Rule58Non-invasive–Rule912Activedevice–Rule1318SpecialClassificationTÜVSÜDGreaterChinaMr.YongjianSUNRule10ClassIIA)B)C)ClassIIIClassIIIRule11ClassIIClassIIITÜVSÜDGreaterChinaClassificationTÜVSÜDGreaterChinaMr.YongjianSUNIn-vitroDevice:RDCNo.61/2011(98/79/EC)ClassIIIIIIIVRule1toRule9BrazilRegistrationHolderTÜVSÜDGreaterChinaMr.YongjianSUNBrazilRegistrationHolder(BRH)ANVISABRH5INMETROBRH(newINMETROregulation,Portaria350/2010)B-GMPBRHEURepINMETROTÜVSÜDGreaterChinaMr.YongjianSUNElectricalMedicaldevicesINMETRORDCNo.27/2011MedicalDevicesINNo.3/2011(ABNTNBRIECXXX,e.g.60601-1/60601-2-xxIECISOnationaldeviations)!!IEC60601-13rdisnowacceptableinBrazilforINMETROcertification201411IVDINMETROIEC61010-1TÜVSÜDGreaterChinaINMETROTÜVSÜDGreaterChinaMr.YongjianSUNINMETROILACaccreditedlabsINMETROILALINMETROINMETROTÜVSÜDGreaterChinaMr.YongjianSUNSyringes,needlesandinfusionsets20136INMETROSurgicalandexaminationgloves-RDCNo.55of4November2011INMETROPVCINMETROTÜVSÜDGreaterChinaMr.YongjianSUNCertificationOCPDocumentReviewUsermanual,DMF,DHFinPortugueseFactoryInspectionISO13485ILACaccreditedlabsTÜVSÜDGreaterChinaINMETROTÜVSÜDGreaterChinaMr.YongjianSUN“FactoryInspections”565GMPTÜVSÜDGreaterChinaMr.YongjianSUNBeforeGMPRDCNo.59of27June2000:BrazilianGoodManufacturingPractices(BGMP)RDCNo.686of1998:BGMPforIVDNow2013GMPRDC16/2013QSR820GMPTÜVSÜDGreaterChinaMr.YongjianSUNClassIIIandIVClassIIIThelistofClassIandIIelectronicmedicaldevicesrequiringBGMPcertificationincludes:–Equipmentusedtodisinfectandsterilizemedicalequipment–Equipmentforprocessingbloodcomponentsusedininfusionprocedures–Medicalsoftwarenotembeddedinequipmentusedformedicalimaging,diagnosticorsurgicalpurposes–Invitrodiagnosticdevicessuchasbiochemicalanalyzers,immunoassayanalyzersorglucosemetersusedtotestsamplesderivedfromahumanbody–Dialyzerreprocessingequipment–Medicalimageprocessingequipment–Resonanceimagingdevices–Devicesthatproducein-vivoimagesofradiopharmaceuticaldistributions–Ultrasoundimagingequipment–EndoscopysystemswithsurgicalapplicationsTÜVSÜDGreaterChinaGMPTÜVSÜDGreaterChinaMr.YongjianSUNGMPBRHANVISA15WRMBGMPTÜVSÜDGreaterChinaMr.YongjianSUNGMP–General–QualitySystemRequirements–DesignControls–ControlofDocuments–PurchasingControls–IdentificationandTraceability–ProcessandProductionControls–InspectionandTesting–Non-ConformingProductsandComponents–CorrectiveAction–Handling,Storage,Distribution,andInstallation–PackagingandLabelingControls–Records–Services–StatisticalTechniquesGMPTÜVSÜDGreaterChinaMr.YongjianSUNCaseStudyTÜVSÜDGreaterChinaGMPTÜVSÜDGreaterChinaMr.YongjianSUNGMPself-auditANVISACasestudyTÜVSÜDGreaterChinaMr.YongjianSUNAANVISABGMPBAOEMBBGMPANVISATÜVSÜDGreaterChinaMr.YongjianSUNANVISA–“cadastre”–“registration”ClassIIIcadastreClassIIIClassIIIIVRegistrationTÜVSÜDGreaterChinaANVISATÜVSÜDGreaterChinaMr.YongjianSUNClassIII“Registration”IN02/2011–Equipmentusedtodisinfectandsterilizemedicalequipment–Equipmentforprocessingbloodcomponentsusedininfusionprocedures–Medicalsoftwarenotembeddedinequipmentusedformedicalimaging,diagnosticorsurgicalpurposes–Invitrodiagnosticdevicessuchasbiochemicalanalyzers,immunoassayanalyzersorglucosemetersusedtotestsamplesderivedfromahumanbody–Dialyzerreprocessingequipment–Medicalimageprocessingequipment–Resonanceimagingdevices–Devicesthatproducein-vivoimagesofradiopharmaceuticaldistributions–Ultrasoundimagingequipment–EndoscopysystemswithsurgicalapplicationsANVISATÜVSÜDGreaterChinaMr.YongjianSUNClassIII“Registration”IN02/2011–Productsconstitutedbygels,creams,pastes,liquidsorpowderthatcomeintodirectcontactwiththeorganism;or–Componentsfororthodonticsfixedintotheteeth;–Filtersforliverdialysis;–FiltersforHemodialysis;–Filtersforremovalofbloodproducts;–Wiresuture;–Contactlenses;–Implantablematerialsintheteeth(eg,resins,amalgam,cementsandcore);–Systemsforaphaeresiswithoutplasticbags;–Circuitsforcardiopulmonarybypass,and–Componentsofdentalimplants.ANVISATÜVSÜDGreaterChinaMr.YongjianSUNAccordingtoAnnexIIIofRDCNo.185/2001(forgeneral)andRDCNo.206/2006(forIVD)ANVISAEconomicInformationReportiRDCNo.185/2006CEFDA510kTÜVSÜ