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1、1 / 18本合同內(nèi)容只做參考CE Certification ContractCE認(rèn)證合同Venue簽訂地點(diǎn):City(Cou nty)市Date簽定日期:Year年Month月Date日Consignor (first party)托付方(甲方)全稱(chēng):2 / 18Cen ter(the seco nd party)認(rèn)證方(乙方)全稱(chēng):ITC ASIACo., LtdVenue簽訂地點(diǎn):City(Cou nty)市Date簽定日期:Year年Month月Date日Registrati on Number Of Con tract合同登記編號(hào)Con te nt and Scope合作的目的、內(nèi)

2、容和范圍1. The sec ond party shall perform con formity assessme nt for CE marking tothe applied products. The objective of con formity assessment is to evaluatethe complianee with the requirements of the MDD 93/42/EEC directives andapplicable conformity procedure.乙方依照甲方提出的申請(qǐng)對(duì)甲方的產(chǎn)品依據(jù)MDDC ertification3 /

3、1893/42/EEC歐盟指令,按照相關(guān)程序進(jìn)行合格評(píng)定。2. The type and model of product in CE product certification:甲方申請(qǐng)CE認(rèn)證的產(chǎn)品描述(包括產(chǎn)品的型號(hào)、商標(biāo)、規(guī)格):Assessment fee and terms of payment費(fèi)用及付款方式1. The C E conformityassessment fee is RMB. CE合格評(píng)定費(fèi)為RMB2. The first party should disbursefrom conformityassessment fee(See Clause 2.1)RMB w

4、ithinthreeworkingdays 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. Afterverification the first party should p

5、ay the all rest assessment fee (See Clause2.1) RMB to second party within three working days. Second party shouldsend the original certificate after reception of that amount.4 / 18在簽訂合同后三個(gè)工作日內(nèi), 甲方向乙方預(yù)付合格評(píng)定費(fèi)中的(即第二條第一款)RMB,在收到相應(yīng)的款項(xiàng)后,乙方開(kāi)始認(rèn)證工作; 在CE評(píng)審合格后,乙方將證書(shū)確認(rèn)件及付款通知函交與甲方,確認(rèn)后 甲方應(yīng)在收到付款通知函后三個(gè)工作日內(nèi)向乙方支付其余合格

6、評(píng)定費(fèi)(即第二條第一款)RMB,乙方在收到余款后向甲方交付認(rèn)證書(shū)原件。3. The fee shall be disbursed to the account appointed by ITC ASIA.以上費(fèi)用打款到ITC ASIA指定賬戶(hù)。Right and obligation of the first party甲方的權(quán)利和義務(wù)1.The first party shall provide the relevant technical documentation inaccordance with the Clauses of 1.2 of this Agreement. And al

7、l technicaldocumentation and medical quality management system should fulfill therequirements set by the second party.依照第一條第二款的協(xié)議內(nèi)容,甲方負(fù)責(zé)向乙方提交相關(guān)的技術(shù)文 件,所有技術(shù)文件和醫(yī)療器械質(zhì)量治理體系應(yīng)符合乙方要求;2. The test should be performed by the ISO 17025 accredited testing laboratory5 / 18or nominated by ITC.產(chǎn)品檢測(cè)應(yīng)在獲得ISO 17025認(rèn)證的實(shí)

8、驗(yàn)室或者得到ITC認(rèn)可的實(shí)驗(yàn) 室進(jìn)行;3. The first party shall implement the corrective actions basedon the non conformity reports which issued by the second party during auditand according to the evaluation of technical construction2 of 6 Registration Number Of Contract合同登記編號(hào):6 / 18file. First party should provide ap

9、propriate evidences to thesecond party against them.甲方負(fù)責(zé)對(duì)乙方在審查和技術(shù)文件評(píng)審工作中發(fā)覺(jué)的不合格項(xiàng)進(jìn)行 整改,并及時(shí)將有關(guān)的證據(jù)提供給乙方;4. The first party has the responsibility for the keeping of safety characteristicof its products and has to maintain the quality of CEqualification. Thesecond party shall inform to the first party ab

10、out the unsatisfied matters forthe first partys product whenever they found the quality of the productscould not meet any regulation (s) or MDD directive (s).甲方應(yīng)對(duì)其產(chǎn)品安全特性負(fù)責(zé),保持CEA證時(shí)質(zhì)量水平。當(dāng)乙方發(fā)覺(jué)甲方產(chǎn)品在歐盟市場(chǎng)不滿(mǎn)足指令要求或有關(guān)法律要求時(shí),應(yīng)通知甲方 須改進(jìn)內(nèi)容,由甲方負(fù)責(zé)處理;5. The first party is responsible for the preparation of the7 / 18

11、“Declarationof Conformity”according to the appliedDirective and the first party should keep the submitted Technical(Construction) File for 10 years.甲方應(yīng)依照指令要求公布符合性聲明,并保留符合性聲明和技術(shù)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 r

12、ight topromote its CE registration to the public correctly after theacquisition of the certificate.在獲得CE證書(shū)后,甲方具有按規(guī)定正確使用CB認(rèn)證標(biāo)記的權(quán)利和對(duì)外 正確宣傳產(chǎn)品認(rèn)證注冊(cè)資格的權(quán)利;7. The first party shall notifying the second party against major customercomplains and any significant changes in quality system, working process,major

13、 production equipment, product specification and key suppliers.8 / 18甲方應(yīng)將重大客戶(hù)投訴及在質(zhì)量體系、 工藝、生產(chǎn)設(shè)備和關(guān)鍵供貨商 發(fā)生重大變化時(shí)通報(bào)乙方;8. The first party shall inform to the second party for the changes of its productscopes. The second party decides whether or notto carry out reassessment or production inspection.甲方要求變更其

14、認(rèn)證范圍時(shí)必須向乙方提出申請(qǐng), 由乙方?jīng)Q定是否重 新進(jìn)行產(chǎn)品審核或檢驗(yàn);9. The first party shall oblige the requested assessment set bythe second party and provide necessary assistance, whenon-siteassessment is necessary according to certification procedure.甲方有義務(wù)遵守乙方認(rèn)證程序和要求, 配合乙方工作, 包括按照認(rèn)證 行業(yè)規(guī)定,乙方到甲方進(jìn)行現(xiàn)場(chǎng)評(píng)審時(shí),甲方應(yīng)給與協(xié)助;10. During co-operation, when terminate the project due to firstparty, first party

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