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ID:40091437
大小:3.81 MB
页数:52页
时间:2019-07-20
《Relevant Requirements of GHTF Medical Device AE Monitoring(Jorge Garcia) 》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、RelevantRequirementsofGHTFMedicalDeviceAEMonitoringDrJorgeGarciaTherapeuticGoodsAdministrationEx-Chairman,GHTFSG2OverviewofthispresentationGHTFGuidanceonMedicalDeviceAEMonitoringandReporting…ExemptionRulesWhat,bywhenandtowhomtoreport…GHTFNCARprogramPost-marketSurveillance“Thepro-act
2、ivecollectionofinformationonquality,safetyorperformanceofMedicalDevicesaftertheyhavebeenplacedinthemarket”–Reference:GHTFSG2N47R4Post-marketVigilance(AdverseEventReporting)(Broadlyspeaking)Vigilanceisthereportingandinvestigationofadverseeventsandincidents.BoththemanufacturerandtheRegula
3、toryAuthorityplaymajorroles.SG2nowpreferstousetheterm“AdverseEventReporting”ImportantConceptAdverseEventreportingandmonitoringisonlyonepartofwellbalancedpostmarketsurveillancesystems.Byitsverynature,AdverseEventreportingandmonitoringisa“reactive”activity.AbalancedPost-MarketSurveilla
4、ncesystemwillcontainanappropriatemixofproactiveandreactiveactivities.Post-marketSurveillancePost-MarketSurveillanceInformationisusedfor:VigilanceInjurypreventionDevelopmentofstandards(adverseeventRegulatoryrefinementinvestigation&Productimprovementreporting)PostMarketSurveillanceGHTFSG2G
5、uidanceonAdverseEventReporting…SG2GuidanceAdverseEventReportingbyManufacturersSG2-N21R8:AdverseEventReportingGuidancefortheMedicalDeviceManufactureroritsAuthorizedRepresentativeSG2/N31R8:ProposalforReportingofUseErrorswithMedicalDevicesbytheirManufacturerorAuthorizedRepresentativeSG2/
6、N32R5:UniversalDataSetforManufacturerAdverseEventReportsSG2-N36R7:Manufacturer'sTrendReportingofAdverseSG2-N33R11:TimingofAdverseEventReportsSG2-N68R3:WhoShouldAdverseEventReportsbeSentTo?GHTFSG2N54R8SG2GuidanceReportHandling&NCARProgramSG2-N8R4:GuidanceonHowtoHandleInformationConcer
7、ningVigilanceReportingRelatedtoMedicalDevicesSG2-N9R11:GlobalMedicalDeviceCompetentAuthorityReportSG2-N20R10:NationalCompetentAuthorityReportExchangeCriteriaSG2-N38R14ApplicationRequirementsforParticipationintheGHTFNationalCompetentAuthorityReportExchangeProgram.GHTFSG
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