欧盟代表协议书.doc

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1、AGREEMENTPARTYA:NAME:ADDRESS:TEL:FAX:PARTYB:NAME:ADDRESS:TEL:FAX:PARTYAherebyappointsPartyBastheauthorizeddelegateofEuropeanCommunityandPartyBacceptstheappointmenttobetheauthorizeddelegateofEuropeanCommunityforPartyAinthemarketofEuropeanCommunities.BothpartiesenterthisAgree

2、mentasfollows:PARTYA1.PartyAassurestoprovidetheupdatedtechnicalfilesofeachcategorytoPartyB.2.Ifthereareanychangesofproducts,PartyAshallnotifyPartyBatonce.3.IftheseriousaccidentofproductishappenedwithinboundaryofEC,PartyAshallinvestigatethereasontogetherwithPartyB,andcomplet

3、etheinitialreportandfinalreport,PartyAshallpresentthesereporttoPartyB,withinregulartimeandreporttocompetentauthority.IftheaccidentofproductsishappenedoutofE.C.PartyAshallnotifyPartyB,andmakedecisionthatwhetherreporttocompetentauthorityornot.4.PartyAshallberesponsibleforanyb

4、usinessdisputesuchasclaimforcompensationcausedbymedicalaccidentsafterPartinhandingthedisputesinaccordancewiththeauthorizationofPartA.AlltheexpenseshappenedduringPartyBhandingoftheaccidentoccurrenceshallbebornePartyA.PARTYB1.PartyBshallresponsibleforregisteringPartyA′sproduc

5、tswithCEmarkwithrelevantcompetentauthorityofthecountrytowhichPartyBislocated.2.PartyBshallreservetechnicalfilesofeachcategoryofPartyA′sproductswithCEmark.Thetechnicalfilesarereservedatleastfiveyearsaftermanufacturingtheproductsoflastbatch.3.PartyBshallnotifyanyinformationab

6、outproductswithCEmarkwithinboundaryofE.C.includingclaimofcustomer.2/24.IftheseriousaccidentofproductishappenedwithinboundaryofE.C.,PartyBshallnotifyaimmediatelyandassistPartyAtohandlevigilancesystemofmedicaldeviceproducts,andalsoreportinitialreport,investigationresultandfin

7、alreporttocompetentauthorityofcountryinwhichtheaccidentishappened.ThiscontractwillbeterminatedautomaticallyiftheCEcertificationofPartAbeingwithdrawnbytheNotifiedBodyduringtheimplementationofthecontract.PartyA:PartyB:Signature:Signature:Date:Date:2/2