英文ce files list

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1、CONTROLLEDTATECEFILESLISTCompiledby:Date:Reviewedby:Date:Approvedby:Date:Version:ADateofcomingintoeffect:CEFILESLISTChapterSerialNo.Title1CEFILESLIST2COMPANYINTRODUCTION3STATEMENTCONCERNINGAUTHORIZEDREPRESENTATIVEESTABLISHEDWITHINEUROPEANCOMMUNITY4PRODUC

2、TSDESCRIPTION5RISKANALYSIS6STATEMENTOFCONFORMITY7CHECKOFBASICSAFETYPOINTS8CONFORMANCETOSTANDARDS9MARKETFEEDBACKORCUSTOMERCOMPLAINTANALYSISREPORT-VIGILANCESYSTEM10LABELINGANDINSTRUCTIONSFORUSE11SPECIFICATIONOFPRODUCTS12REVIEWDOCUMENTSFORMANUFACTUREANDTEST

3、13SPECIALPROCEDURES14PACKAGINGMATERIALS15CLINICALTRIALSREPORTCONTROLLEDSTATE　COMPANYINTRODUCTION　Compiledby:Date:Reviewedby:Date:Approvedby:Date:Version:ADateofcomingintoeffect:COMPANYINTRODUCTIONCONTROLLEDSTATE　STATEMENTCONCERNINGAUTHORIZEDREPRESENTATIV

4、EESTABLISHEDWITHINEUROPEANCOMMUNITYCompiledby:Date:Reviewedby:Date:Approvedby:Date:Version:ADateofcomingintoeffect:StatementconcerningAuthorizedRepresentativeEstablishedwithinEuropeanCommunityWehavenotsoldproductsinEuropeandnotappointedAuthorizedRepresen

5、tativeEstablishedwithinEuropeanCommunity.WewillnominateDistributorandAuthorizedRepresentativeEstablishedwithinEuropeanCommunityandinformNotifiedBodybeforeourproductswereexportedtoEurope.PostsignaturedateCONTROLLEDSTATE　PRODUCTSDESCRIPTIONCompiledby:Date:

6、Reviewedby:Date:Approvedby:Date:Version:ADateofcomingintoeffect:PRODUCTSDESCRIPTIONCONTROLLEDSTATE　RISKANALYSISCompiledby:Date:Reviewedby:Date:Approvedby:Date:Version:ADateofcomingintoeffect:1.Foreword2.Indications3.MechanismofAction4.Description1).Appea

7、rance2).Amountofproduct5.TypeandSizeTypeSizepowderointment6.Questionsthatcanbeusedtoidentityproductcharacteristicsthatcouldimpactonsafety：1).Whatistheintendeduse/intendedpurposeandhowisthemedicaldevicetobeused?2.)Isthemedicaldeviceintendedtocontactthepat

8、ientorotherpersons?3).Whatmaterialsand/orcomponentsareincorporatedinthemedicaldeviceorareusedwith,orareincontactwith,themedicaldevice?4).Isenergydeliveredtoand/orextractedfromthepatient?5).Aresubstancesdeliveredtoand/orext