医疗器械行业-加拿大销售产品投诉处理程序

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1、医疗器械行业-加拿大销售产品投诉处理程序1．PurposeEstablishandimplementtheprocedure,insurecomplaintsberecordedandclearlybehandledintherightway.2．ScopeTheprocedureappliestothedevicesalesinCanada.3．Responsibilities3.1InternationalMarketingDept.takestheresponsibilityofcontractreview,makesuretheobligationofc

2、omplainthandlingrelatedshowsintheformalcontractformat.3.2InternationalServicingDept.takestheresponsibilityofmaintenancerecordandcollectsothercomplaintinfo.3.3Otherrelateddepartmentssupporttoinvestigateproblems.3.4QAdept.handlestheMandatoryProblemReportingandRecallingissues.4．Procedur

3、e4.1InternationalServicingDept.maintainsrecordsofthefollowing:(a)reportedproblemsrelatingtotheperformancecharacteristicsorsafetyofthedevice,includinganyconsumercomplaints,receivedfromtheimporterordistributorafterthedevicewasfirstsoldinCanada;and(b)allactionstakenbyMinray,importerordi

4、stributorinresponsetotheproblemsreferredtoinparagraph(a).(2)Subsection(1)doesnotapplyto(a)aretailer;or(b)ahealthcarefacilityinrespectofamedicaldevicethatisdistributedforusewithinthatfacility.4.2ProblemInvestigationasto•whetherthereisahealthhazardassociatedwiththedevice;•whetherthedev

5、icefailstoconformtoanyclaimmadebythemanufacturerorimporterrelatingtoitseffectiveness,benefits,performancecharacteristicsorsafety;•whetherthedevicefailstomeetanyrequirementoftheActortheRegulations;•whatpreventative/correctiveactionisappropriateonthebasisoftheaboveinformation;and•wheth

6、eradecisionnottotakeactionisjustified,asinthecaseofanunfoundedorinvalidcomplaint.4.3DescriptionoftheProblem/IncidentThereportshouldincludeadetaileddescriptionoftheproblemorincidentandthecircumstancesthatledtothediscoveryofthedefectivenessorpossibledefectivenessofthedevice,aswellasthe

7、datethattheproblemwasfirstnoticed.4.4HealthHazardEvaluationToassessthehealthhazard,thefirmmustgather,correlateandevaluateallknowninformationonthenatureandextentofthereputedhealthrisk.Thefactorsconsideredmayincludebutarenotlimitedtothefollowing:•death,diseaseorinjurythathasalreadyoccu

8、rredfromuseo