CE Certification Contract合同认证样板gdf.docx

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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 ce

17、rtificate 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，乙方将撤销该证书，甲方应返还该证书原件。 3 of 6 Registration Number Of Contract 合同登记编号: CE-090826-01 四. Right And Obligation of the Second Party 乙方的权利和义务1. When the contract signed the second party has to provide the index of directive(s) and standard

18、(s) to the first party for conformity assessment. 自本合同签订之日起，乙方负责组织认证工作需要的指令和标准目录（中文），并将此目录正式提交给甲方； 2. Since the date when the contract is signed, the second party has responsibility to forward the list of technical file for conformity assessment. 自本合同签订之日起，乙方负责向甲方提供认证所需要的技术文件清单（中文）； 3. The second pa

19、rty shall arrange competent technical personnel bases on the needs of conformity assessment, the appointed assessment team should submit questions objectively and practically, and deal with relative questions in process of conformity assessment justly and scientifically. 乙方根据认证工作需要配备有能力的专业技术人员，乙方指定的

20、审核组应客观、实事求是地提出问题并公正、科学地处理审核中的有关问题； 4. The second party shall provide the assessment report together with non-compliance notice to the first party for corrective actions. 乙方应该提交评审报告及不合格通知以便甲方进行整改； 5. The second party shall review the assessment conclusion initially, and forward relative information t

21、o head office for final assessment. The second party should notice the conclusion to the first party in 3 working days once gets the result. 乙方将认证的结论进行初步评审，初审通过后，将有关的资料送交乙方总部进行最终评审，取得评审结果后在三个工作日内通知甲方； 6. The second party shall carry out the assessment for product according to the requirement of dire

22、ctive, to verify the legal access of product to the EU market. 乙方按照欧盟产品指令要求对产品进行评审，合格后确认甲方产品具备进入欧盟市场资格； 7. Second party assess the technical document and system for the applied product by first party according to this contract. If the technical construction file of the applied product and applicable

23、 tests meet the requirements of applicable EU Directive and applicable standards of testing, the first party should issue certificate by ITC. 乙方根据合同规定对甲方申请的产品提供CE申请和技术文件评审，按照欧盟相关指令的要求确认甲方技术文件和产品经相关检测合格后，为甲方发放ITC评审的CE认证证书。五. Confidentiality 保密条款The second party shall not give information to any third

24、 party regarding the production and technical data of the first party in any forms, with the following exception. If not, the second party should pay the damages to first party. 乙方不得将甲方经营、生产状况及技术信息以任何方式向第三方泄漏，但下列情况除外。若乙方违反前述保密条款，乙方应赔付给甲方造成的直接和间接损失。1. Information obtained by the second party before s

25、igning of this contract. 此合同签署前乙方收到的信息； 4 of 6 Registration Number Of Contract 合同登记编号: CE-090826-01 2. Any information which is lawfully part of the public date. 甲方在认证范围外已公开的资料； 3. Legal access has been obtained. 法律另有要求时； 4. The authority has such demand. 国家主管部门要求时。六. The amendment and cancellation

26、of the contract 合同的变更和解除After the contract going into effect, the first party and the second party should strictly carry out the obligations according to the contract. Any party cannot terminate or amend the contract on its own; the two parties must negotiate and reach the agreement to complement, a

27、mend and terminate the contract when necessary. 合同生效后，甲乙双方均应严格按照本合同条款履行义务，任何一方不得单独终止、修改本合同；如需补充、修改和终止合同，须经双方协调一致达成共识后进行。七. Settlement of Disputes 争议处理All the items of this contract are complied with the laws and regulations of the PRC. Disputes caused by this contract should be firstly solved by fri

28、endly negotiation between the first party and the second party. Unsolved disputes can be solved by the following approached: 本合同所有条款均满足中华人民共和国的法律、法规要求。因本合同所发生的争议，甲乙双方应采取协商方法解决。如达不成协议可以采取以下解决方式： 1. Referred to related Arbitration Commission. 申请相关仲裁委员会仲裁； 2. Settled by going to the court located near

29、the first party. 向甲方所在地的人民法院提起诉讼。八、 Other 其它This contract shall be valid upon signing and be in duplicate, one copy for each party. During the execution of this contract, all the formal information of both parties should be expressed in written. 本合同一式两份，甲、乙双方各执一份，自签字之日起生效。本合同执行期间，双方所有的正式信息均应以书面形式表达。

30、 5 Consignor (the first party)委托方（甲方）： （盖章） Legal representative: 法定代表人： Person to contact 联系人： Telephone 电话： Fax 传真: Bank 开户银行： Bank Account: 户名 Bank Number: 帐号 Address: 通讯地址： Postal code: 邮政编码： Representative of Certification Body (the second party)认证证书代理方（乙方）： （盖章） Legal representative: 法定代表人： Person to contact 联系人： 李新雨 Telephone: 电话： Fax: 传真： Bank 开户银行： SWIFT Code环银号: Bank Account: 户名： Bank Number: 帐号： Address: 通讯地址： Seoul, Korea Postal code: 邮政编码： 6