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1、本合同内容只做参考 CE Certification Contract CE认证合同 Consignor (first party) 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C ertification Center(the second party)认证方（乙方）全称： ITC ASIA Co., Ltd Venue签订地点： City(County)市Date 签定日期： Year年Month月Date日Registration Number Of Contract 合同登记编号: 一 Content an
2、d Scope 合作的目的、内容和范围1. The second party shall perform conformity assessment for CE marking to the applied products. The objective of conformity assessment is to evaluate the compliance with the requirements of the MDD 93/42/EEC directives and applicable conformity procedure. 乙方根据甲方提出的申请对甲方的产品依据MDD 93
3、/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）：二 Assessment fee and terms of payment 费用及付款方式 1. The CE conformity assessment fee is RMB. CE合格评定费为RMB。2. The first party should disburse from conformity assessment fee (See Clause 2.1)
4、 RMB within three working days after the contract signed. The second party should carry out the assessment after reception of the fee. Once CE conformity assessment finished, the second party shall send the copy of the certificate for verification by first party with invoice. After verification the
5、first party should 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
6、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. 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。三 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
7、 this Agreement. And all technical documentation and medical quality management system should fulfill the requirements set by the second party. 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. The test should be performed by the ISO 17025 accredited testing laboratory or nominated by ITC.
8、 产品检测应在获得ISO 17025认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 based on the non conformity reports which issued by the second party during audit and according to the evaluation of technical construction 2 of 6 Registration Number Of Contract 合同登记编号: file. First pa
9、rty should provide appropriate evidences to the second party against them. 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. The first party has the responsibility for the keeping of safety characteristic of its products and has to maintain the quality of CE qualification. The second party shall in
10、form to the first party about 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. The first party is responsible for
11、 the preparation of the “Declaration of Conformity” according to the applied Directive and the first party should keep the submitted Technical (Construction) File for 10 years. 甲方应根据指令要求发布符合性声明，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 to the defined requirement
12、s and directives, and has the right to promote its CE registration to the public correctly after the acquisition of the certificate. 在获得CE证书后，甲方具有按规定正确使用CE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 qu
13、ality system, working process, major 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 not to carry out reassessment
14、or production inspection. 甲方要求变更其认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 by the second party and provide necessary assistance, when on-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
15、现场评审时，甲方应给与协助； 10. During co-operation, when terminate the project due to first party, first party shall make payment in terms of progress of the project; when terminate the project due to second party, first party owns right of recourse. 项目合作过程中，因甲方原因中止项目时，甲方应按项目进展程度支付款项；因乙方原因中止项目时，乙方应赔付给甲方造成的直接和间接
16、损失，同时甲方拥有追索权； 11. During the period of validity, the first party should accept surveillance audit within the date one month before the certificate issuing. If they refuse to accept the surveillance audit, the second party will cancel the certificate. And the first party should return the original certificate to the second party. 在证书有效期内，甲方应在每年证书颁发日期前一个月内接受年审；如拒不接受年审，乙方将撤销
