1、本合同內容只做參考 CE Certification Contract CE 認證合同Consignor (first party 委托方(甲方全稱:Venue 簽訂地點:City(County市Date 簽定日期:Year 年 Month 月 Date 日C ertification Center(the second party認證方(乙方全稱:Venue 簽訂地點:City(County市Date 簽定日期:Year 年 Month 月 Date 日Registration Number Of Contract 合同登記編號 :一. Content and Scope 合作的目的、內容和

2、范圍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. 乙方根據甲方提出的申請對甲方的產品依 據 MDD 93/42/EEC歐盟指令,按照相

3、關程序進行合格評定。2. The type and model of product in CE product certification:甲方申請 CE 認證的產品描述(包括產品的型號、商標、規格 :二. Assessment fee and terms of payment 費用及付款方式1. The CE conformity assessment fee is RMB. CE合格評定費為 RMB 。2. The first party should disburse from conformity assessment fee (See Clause 2.1 RMB within t

4、hree 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 copyof the certificate for verification by first party with invoice. After verification the first party sho

5、uld 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.在簽訂合同后三個工作日內,甲方向乙方預付合格評定費中的 (即第二條第 一款 RMB,在收到相應的款項后,乙方開始認證工作;在 CE 評審合格后,乙方將證書確認件及付款通知函交與甲方,確認后甲方 應在收到付款通知函后三個工作日內向乙方支付其余

6、合格評定費 (即第二 條第一款 RMB,乙方在收到余款后向甲方交付認證書原件。3. The fee shall be disbursed to the account appointed by ITC ASIA.以上費用打款到 ITC ASIA指定賬戶。三. Right and obligation of the first party 甲方的權利和義務1. The first party shall provide the relevant technical documentation in accordance with the Clauses of 1.2 of this Agreem

7、ent. And all technical documentation and medical quality management system should fulfill the requirements set by the second party.根據第一條第二款的協議內容, 甲方負責向乙方提交相關的技術文件, 所 有技術文件和醫療器械質量管理體系應符合乙方要求;2. The test should be performed by the ISO 17025 accredited testing laboratory or nominated by ITC.產品檢測應在獲得 IS

8、O 17025認證的實驗室或者得到 ITC 認可的實驗室進 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 construction2 of 6 Registration Number Of Contract 合同登記編號 :file. First party should

9、 provide appropriate evidences to the second party against them.甲方負責對乙方在審查和技術文件評審工作中發現的不合格項進行整改, 并及時將有關的證據提供給乙方;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 inform to the

10、 first party about the unsatisfied matters for the first party's product whenever they found the quality of the products could not meet any regulation (s or MDD directive (s.甲方應對其產品安全特性負責, 保持 CE 認證時質量水平。 當乙方發現甲方 產品在歐盟市場不滿足指令要求或有關法律要求時,應通知甲方須改進內 容,由甲方負責處理;5. The first party is responsible for the

11、 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. 甲方應根據指令要 求發布符合性聲明,并保留符合性聲明和技術文件 10年;6. The first party has the right to use its CE mark according to the defined requirements an

12、d directives, and has the right to promote its CE registration to the public correctly after the acquisition of the certificate.在獲得 CE 證書后,甲方具有按規定正確使用 CE 認證標記的權利和對外正 確宣傳產品認證注冊資格的權利;7. The first party shall notifying the second party against major customer complains and any significant changes in qua

13、lity system, working process, major production equipment, product specification and key suppliers.甲方應將重大客戶投訴及在質量體系、 工藝、 生產設備和關鍵供貨商發生 重大變化時通報乙方;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.甲方要求變更其認證范圍時必須向乙方提出申請, 由乙方決定是否重新進 行產品審核或檢驗;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.甲方有義務遵守乙方認證程序和要求, 配合乙方工作, 包括按照認證行業 規定,乙方到甲方

15、進行現場評審時,甲方應給與協助;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.項目合作過程中, 因甲方原因中止項目時, 甲方應按項目進展程度支付款項;因乙方原因中止項目時,乙方應賠付給甲方造成的直接和

16、間接損失, 同時甲方擁有追索權;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

17、certificate to the second party.在證書有效期內, 甲方應在每年證書頒發日期前一個月內接受年審; 如拒 不接受年審,乙方將撤銷該證書,甲方應返還該證書原件。3 of 6 Registration Number Of Contract 合同登記編號 : CE-090826-01四 . Right And Obligation of the Second Party 乙方的權利和義務1. When the contract signed the second party has to provide the index of directive(s and stand

18、ard(s to the first party for conformity assessment. 自本合同簽訂之日起, 乙方負責組織認證工作需要的指令和標準目錄 (中 文 ,并將此目錄正式提交給甲方;2. Since the date when the contract is signed, the second party has responsibility to forward the list of technical file for conformity assessment.自本合同簽訂之日起,乙方負責向甲方提供認證所需要的技術文件清單 (中文 ;3. The second

19、 party 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.乙方根據認證工作需要配備有能力的專業技術人員, 乙方

20、指定的審核組應 客觀、實事求是地提出問題并公正、科學地處理審核中的有關問題; 4. The second party shall provide the assessment report together with non-compliance notice to the first party for corrective actions.乙方應該提交評審報告及不合格通知以便甲方進行整改;5. The second party shall review the assessment conclusion initially, and forward relative information

21、 to head office for final assessment. The second party should notice the conclusion to the first party in 3 working days once gets the result.乙方將認證的結論進行初步評審, 初審通過后, 將有關的資料送交乙方總 部進行最終評審,取得評審結果后在三個工作日內通知甲方;6. The second party shall carry out the assessment for product according to the requirement of d

22、irective, to verify the legal access of product to the EU market.乙方按照歐盟產品指令要求對產品進行評審, 合格后確認甲方產品具備進 入歐盟市場資格;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 applica

23、ble tests meet the requirements of applicable EU Directive and applicable standards of testing, the first party should issue certificate by ITC.乙方根據合同規定對甲方申請的產品提供 CE 申請和技術文件評審,按照 歐盟相關指令的要求確認甲方技術文件和產品經相關檢測合格后, 為甲方 發放 ITC 評審的 CE 認證證書。五 . Confidentiality 保密條款The second party shall not give information

24、to any third 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. 乙方不得將甲方經營、生產狀況及技術信息以任何方式向第三方泄漏，但下 列情況除外。若乙方違反前述保密條款，乙方應賠付給甲方造成的直接和間 接損失。 1. Information obtained by the second

25、 party before signing of this contract. 此合同簽署前乙方收到的信息； 4 of 6 Registration Number Of Contract 合同登記編號: CE-090826-01 2. Any information which is lawfully part of the public date. 甲方在認證范圍外已公開的資料； 3. Legal access has been obtained. 法律另有要求時； 4. The authority has such demand. 國家主管部門要求時。 六. The amendment a

26、nd cancellation of the contract 合同的變更和解除 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

27、 to complement, amend and terminate the contract when necessary. 合同生效后，甲乙雙方均應嚴格按照本合同條款履行義務，任何一方不得單獨終 止、修改本合同；如需補充、修改和終止合同，須經雙方協調一致達成共識后進 行。 七. Settlement of Disputes 爭議處理 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 friendly negotiation between the first party and the second party. Unsolved disputes can be solved by the following approached: 本合同所有條款均滿足中華人民共和國的法律