本合同内容只做参考CECertificationContractCE认证合同Consignor(firstparty)委托方(甲方)全称：Venue签订地点：City(County)市Date签定日期：Year年Month月Date日CertificationCenter(thesecondparty)认证方(乙方)全称：ITCASIACo・,LtdVenue签订地点：City(County)市Date签定日期：Year年Month月Date日RegistrationNumberOfContract合同登记编号：一.ContentandScope合作的目的、内容和范围1.ThesecondpartyshallperformconformityassessmentforCEmarkingtotheappliedproducts.TheobjectiveofconformityassessmentistoevaluatethecompliancewiththerequirementsoftheMDD93/42/EECdirectivesandapplicableconformityprocedure.乙方根据甲方提出的申请对甲方的产品依据MDD93/42/EEC欧盟指令，按照相关程序进行合格评定。2.ThetypeandmodelofproductinCEproductcertification:甲方申请。£认证的产品描述(包括产品的型号、商标、规格)：二.Assessmentfeeandtermsofpayment费用及付款方式1.TheCEconformityassessmentfeeisRMB.CE合格评定费为RMB。2.Thefirstpartyshoulddisbursefromconformityassessmentfee(SeeClause2.1)RMBwithinthreeworkingdaysafterthecontractsigned.Thesecondpartyshouldcarryouttheassessmentafterreceptionofthefee.OnceCEconformityassessmentfinished,thesecondpartyshallsendthecopyofthecertificateforverificationbyfirstpartywithinvoice.Afterverificationthefirstpartyshouldpaytheallrestassessmentfee（SeeClause2.1）RMBtosecondpartywithinthreeworkingdays.Secondpartyshouldsendtheoriginalcertificateafterreceptionofthatamount.在签订合同后三个工作日内，甲方向乙方预付合格评定费中的（即第二条第一款）RMB,在收到相应的款项后，乙方开始认证工作；在CE评审合格后，乙方将证书确认件及付款通知函交与甲方，确认后甲方应在收到付款通知函后三个工作日内向乙方支付其余合格评定费（即第二条第一款）RMB，乙方在收到余款后向甲方交付认证书原件。3.ThefeeshallbedisbursedtotheaccountappointedbyITCASIA.以上费用打款到ITCASIA指定账户。三.Rightandobligationofthefirstparty甲方的权利和义务1.ThefirstpartyshallprovidetherelevanttechnicaldocumentationinaccordancewiththeClausesof1.2ofthisAgreement.Andalltechnicaldocumentationandmedicalqualitymanagementsystemshouldfulfilltherequirementssetbythesecondparty.根据第一条第二款的协议内容，甲方负责向乙方提交相关的技术文件，所有技术文件和医疗器械质量管理体系应符合乙方要求；2.ThetestshouldbeperformedbytheISO17025accreditedtestinglaboratoryornominatedbyITC.产品检测应在获得ISO17025认证的实验室或者得到ITC认可的实验室进行；3.Thefirstpartyshallimplementthecorrectiveactionsbasedonthenonconformityreportswhichissuedbythesecondpartyduringauditandaccordingtotheevaluationoftechnicalconstruction2of6RegistrationNumberOfContract合同登记编号：file.Firstpartyshouldprovideappropriateevidencestothesecondpartyagainstthem.甲方负责对乙方在审查和技术文件评审工作中发现的不合格项进行整改，并及时将有关的证据提供给乙方；4.ThefirstpartyhastheresponsibilityforthekeepingofsafetycharacteristicofitsproductsandhastomaintainthequalityofCEqualification.Thesecondpartyshallinformtothefirstpartyabouttheunsatisfiedmattersforthefirstparty'sproductwhenevertheyfoundthequalityoftheproductscouldnotmeetanyregulation(s)orMDDdirective(s).甲方应对其产品安全特性负责，保持CE认证时质量水平。当乙方发现甲方产品在欧盟市场不满足指令要求或有关法律要求时，应通知甲方须改进内容，由甲方负责处理；5.Thefirstpartyisresponsibleforthepreparationofthe“DeclarationofConformity”accordingtotheappliedDirectiveandthefirstpartyshouldkeepthesubmittedTechnical(Construction)Filefor10years.甲方应根据指令要求发布符合性声明，并...
