CE认证合同模板实用样本

1、本合同内容只做参考CE Certification ContractCE认证合同Consignor (first party)托付方（甲方）全称：Venue签订地点：City(Cou nty)市Date 签定日期： Year 年 Month 月 Date 日9 / 18C ertificati onCen ter(the seco nd party)认证方(乙方)全称： ITC ASIACo., LtdVenue签订地点：City(Cou nty)市Date签定日期：Year年Month月Date日Registrati on Number Of Con tract合同登记编号Con te nt

2、 and Scope合作的目的、内容和范围1. The sec ond party shall perform con formity assessme nt for CE marking to the applied products. The objective of con formity assessment is to evaluate the complianee with the requirements of the MDD 93/42/EEC directives and applicable conformity procedure.乙方依照甲方提出的申请对甲方的产品依据M

3、DD93/42/EEC欧盟指令，按照相关程序进行合格评定。2. The type and model of product in CE product certification:甲方申请CE认证的产品描述（包括产品的型号、商标、规格）：Assessment fee and terms of payment 费用及付款方式1. The C E conformityassessment fee is RMB. CE合格评定费为 RMB2. The first party should disbursefrom conformityassessmentfee(See Clause 2.1)RMB

4、withinthreeworkingdays afterthecontract signed.The secondpartyshouldcarry outtheassessment after reception of the fee.Once CE conformity assessment finished, the second party shallsend the copy of the certificate for verification by first party with invoice. After verification the first party should

5、 pay the all rest assessment fee (See Clause 2.1) RMB to second party within three working days. Second party should send the original certificate after reception of that amount.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

6、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. The fee shall be disbursed to the account appointed by ITC ASIA. 以上费用打款到 ITC ASIA 指定账户。Right and obligation of the first party甲方的权利和义务1. The first party shall provide the relevant technical documentation in accordance with the Clauses of 1.2 of this Agreement.

7、And all technical documentation and medical quality management system should fulfill the requirements set by the second party.依照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治理体系应符合乙方要求；2. The test should be performed by the ISO 17025 accredited testing laboratory or nominated by ITC.产品检测应在获得ISO 17025认

8、证的实验室或者得到ITC认可的实验 室进行；3. The first party shall implement the corrective actions basedon the non conformity reports which issued by the second party during audit and according to the evaluation of technical construction2 of 6 Registration Number Of Contract合同登记编号 :file. First party should provide app

9、ropriate evidences to thesecond party against them.甲方负责对乙方在审查和技术文件评审工作中发觉的不合格项进行 整改，并及时将有关的证据提供给乙方；4. The first party has the responsibility for the keeping of safety characteristic of its products and has to maintain the quality of CEqualification. The second party shall inform to the first party a

10、bout the unsatisfied matters for the first partys product whenever they found the quality of the products could not meet any regulation (s) or MDD directive (s).甲方应对其产品安全特性负责，保持CEA证时质量水平。当乙方发觉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. The first party is responsible for the preparation of the“D

11、eclarationof Conformity ” according to the appliedDirective and the first party should keep the submitted Technical (Construction) File for 10 years.甲方应依照指令要求公布符合性声明，并保留符合性声明和技术文件10年；6. The first party has the right to use its CE mark according tothe defined requirements and directives, and has the

12、right topromote its CE registration to the public correctly after theacquisition of the certificate.在获得CE证书后，甲方具有按规定正确使用CB认证标记的权利和对外 正确宣传产品认证注册资格的权利；7. The first party shall notifying the second party against major customer complains and any significant changes in quality system, working process, ma

13、jor production equipment, product specification and key suppliers.甲方应将重大客户投诉及在质量体系、 工艺、生产设备和关键供货商 发生重大变化时通报乙方；8. The first party shall inform to the second party for the changes of its product scopes. The second party decides whether or notto carry out reassessment or production inspection. 甲方要求变更其认

14、证范围时必须向乙方提出申请， 由乙方决定是否重 新进行产品审核或检验；9. The first party shall oblige the requested assessment set bythe second party and provide necessary assistance, whenon-site assessment is necessary according to certification procedure. 甲方有义务遵守乙方认证程序和要求， 配合乙方工作， 包括按照认证 行业规定，乙方到甲方进行现场评审时，甲方应给与协助；10. During co-operation, when terminate the project due to firstparty, first