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Relevant Requirements of GHTF Medical Device AE Monitoring

Relevant Requirements of GHTF Medical Device AE Monitoring

ID：40091408

大小：3.83 MB

页数：52页

时间：2019-07-20

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1、RelevantRequirementsofGHTFMedicalDeviceAEMonitoringDrJorgeGarciaTherapeuticGoodsAdministrationEx-Chairman,GHTFSG2OverviewofthispresentationGHTFGuidanceonMedicalDeviceAEMonitoringandReporting…ExemptionRulesWhat,bywhenandtowhomtoreport…GHTFNCARprogramPost-marketSurveillance“Thepro-acti

2、vecollectionofinformationonquality,safetyorperformanceofMedicalDevicesaftertheyhavebeenplacedinthemarket”–Reference:GHTFSG2N47R4Post-marketVigilance(AdverseEventReporting)(Broadlyspeaking)Vigilanceisthereportingandinvestigationofadverseeventsandincidents.BoththemanufacturerandtheRegulato

3、ryAuthorityplaymajorroles.SG2nowpreferstousetheterm“AdverseEventReporting”ImportantConceptAdverseEventreportingandmonitoringisonlyonepartofwellbalancedpostmarketsurveillancesystems.Byitsverynature,AdverseEventreportingandmonitoringisa“reactive”activity.AbalancedPost-MarketSurveillance

4、systemwillcontainanappropriatemixofproactiveandreactiveactivities.Post-marketSurveillancePost-MarketSurveillanceInformationisusedfor:VigilanceInjurypreventionDevelopmentofstandards(adverseeventRegulatoryrefinementinvestigation&Productimprovementreporting)PostMarketSurveillanceGHTFSG2Guida

5、nceonAdverseEventReporting…SG2GuidanceAdverseEventReportingbyManufacturersSG2-N21R8:AdverseEventReportingGuidancefortheMedicalDeviceManufactureroritsAuthorizedRepresentativeSG2/N31R8:ProposalforReportingofUseErrorswithMedicalDevicesbytheirManufacturerorAuthorizedRepresentativeSG2/N32R5

6、:UniversalDataSetforManufacturerAdverseEventReportsSG2-N36R7:Manufacturer'sTrendReportingofAdverseSG2-N33R11:TimingofAdverseEventReportsSG2-N68R3:WhoShouldAdverseEventReportsbeSentTo?GHTFSG2N54R8SG2GuidanceReportHandling&NCARProgramSG2-N8R4:GuidanceonHowtoHandleInformationConcerningVi

7、gilanceReportingRelatedtoMedicalDevicesSG2-N9R11:GlobalMedicalDeviceCompetentAuthorityReportSG2-N20R10:NationalCompetentAuthorityReportExchangeCriteriaSG2-N38R14ApplicationRequirementsforParticipationintheGHTFNationalCompetentAuthorityReportExchangeProgram.GHTFSG

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