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1、本合同內(nèi)容容只做參考考 CE Ceertifficattion Conttractt CE認(rèn)證合合同 Coonsiggnor (firrst ppartyy) 委托托方(甲方方)全稱: Venuee簽訂地點(diǎn)點(diǎn): Ciity(CCountty)市Date 簽定日期期: Yeear年Montth月Datee日C erttificcatioon Ceenterr(thee seccond partty)認(rèn)證證方(乙方方)全稱: ITC ASIAA Co., Lttd Venuee簽訂地點(diǎn)點(diǎn): Ciity(CCountty)市Date 簽定日期期: Yeear年Montth月Datee日Regisst

2、rattion Numbber OOf Coontraact 合合同登記編編號(hào): 一 Coontennt annd Sccope 合作的目目的、內(nèi)容容和范圍1. Thhe seecondd parrty sshalll perrformm connformmity asseessmeent ffor CCE maarkinng too thee apppliedd prooductts. TThe oobjecctivee of confformiity aassesssmennt iss to evalluatee thee commpliaance withh thee reqquiree

3、mentts off thee MDDD 93/42/EEEC ddirecctivees annd apppliccablee connformmity proccedurre. 乙乙方根據(jù)甲甲方提出的的申請(qǐng)對(duì)甲甲方的產(chǎn)品品依據(jù)MDDD 933/42/EEC歐歐盟指令,按按照相關(guān)程程序進(jìn)行合合格評(píng)定。2. Thhe tyype aand mmodell of prodduct in CCE prroducct ceertifficattion: 甲方申請(qǐng)CCE認(rèn)證的的產(chǎn)品描述述(包括產(chǎn)產(chǎn)品的型號(hào)號(hào)、商標(biāo)、規(guī)格):二 Asssesssmentt feee andd terrms oof paa

4、ymennt 費(fèi)用用及付款方方式 1. Thhe CEE connformmity asseessmeent ffee iis RRMB. CE合格格評(píng)定費(fèi)為為RMB。2. Thhe fiirst partty shhouldd dissbursse frrom cconfoormitty asssesssmentt feee (Seee Cllausee 2.11) RMMB wiithinn thrree wworkiing ddays afteer thhe coontraact ssigneed. TThe sseconnd paarty shouuld ccarryy outt th

5、ee asssessmment afteer reecepttion of tthe ffee. Once CE cconfoormitty asssesssmentt finnisheed, tthe sseconnd paarty shalll seend tthe ccopy of tthe ccertiificaate ffor vverifficattion by ffirstt parrty wwith invooice. Aftter vverifficattion the firsst paarty shouuld ppay tthe aall rrest asseessmee

6、nt ffee (See Clauuse 22.1) RMB tto seecondd parrty wwithiin thhree workking dayss. Seecondd parrty sshoulld seend tthe oorigiinal certtificcate afteer reecepttion of tthat amouunt. 在簽訂合同同后三個(gè)工工作日內(nèi),甲甲方向乙方方預(yù)付合格格評(píng)定費(fèi)中中的(即第二條條第一款) RMBB,在收到到相應(yīng)的款款項(xiàng)后,乙乙方開始認(rèn)認(rèn)證工作; 在CE評(píng)審審合格后,乙乙方將證書書確認(rèn)件及及付款通知知函交與甲甲方,確認(rèn)認(rèn)后甲方應(yīng)應(yīng)在收到付

7、付款通知函函后三個(gè)工工作日內(nèi)向向乙方支付付其余合格格評(píng)定費(fèi)(即第二條條第一款) RMBB,乙方在在收到余款款后向甲方方交付認(rèn)證證書原件。3. Thhe feee shhall be ddisbuursedd to the accoount appoointeed byy ITCC ASIIA. 以上費(fèi)用打打款到ITTC ASSIA指定定賬戶。三 Riight and obliigatiion oof thhe fiirst partty 甲方方的權(quán)利和和義務(wù)1. Thhe fiirst partty shhall provvide the releevantt tecchniccal ddoc

8、ummentaationn in accoordannce wwith the Clauuses of 11.2 oof thhis AAgreeementt. Annd alll teechniical docuumenttatioon annd meedicaal quualitty maanageementt sysstem shouuld ffulfiill tthe rrequiiremeents set by tthe sseconnd paarty. 根據(jù)第一條條第二款的的協(xié)議內(nèi)容容,甲方負(fù)負(fù)責(zé)向乙方方提交相關(guān)關(guān)的技術(shù)文文件,所有有技術(shù)文件件和醫(yī)療器器械質(zhì)量管管理體系應(yīng)應(yīng)符合乙方

9、方要求; 2. Thhe teest sshoulld bee perrformmed bby thhe ISSO 177025 accrreditted ttestiing llaborratorry orr nomminatted bby ITTC. 產(chǎn)品檢測(cè)應(yīng)應(yīng)在獲得IISO 1170255認(rèn)證的實(shí)實(shí)驗(yàn)室或者者得到ITTC認(rèn)可的的實(shí)驗(yàn)室進(jìn)進(jìn)行; 3. Thhe fiirst partty shhall impllemennt thhe coorrecctivee acttionss bassed oon thhe noon coonforrmityy repportss whiich i

10、issueed byy thee seccond partty duuringg auddit aand aaccorrdingg to the evalluatiion oof teechniical consstrucctionn 2 of 6 Reegisttratiion NNumbeer Off Conntracct 合同同登記編號(hào)號(hào): file. Firrst ppartyy shoould provvide apprropriiate eviddencees too thee seccond partty aggainsst thhem. 甲方負(fù)責(zé)對(duì)對(duì)乙方在審審查和技術(shù)術(shù)文件評(píng)審

11、審工作中發(fā)發(fā)現(xiàn)的不合合格項(xiàng)進(jìn)行行整改,并并及時(shí)將有有關(guān)的證據(jù)據(jù)提供給乙乙方; 4. Thhe fiirst partty haas thhe reesponnsibiilityy forr thee keeepingg of safeety ccharaacterristiic off itss prooductts annd haas too maiintaiin thhe quualitty off CE quallificcatioon. TThe sseconnd paarty shalll innformm to the firsst paarty abouut thhe unnsa

12、tiisfieed maatterrs foor thhe fiirst parttys prodduct whenneverr theey foound the quallity of tthe pproduucts coulld noot meeet aany rregullatioon (ss) orr MDDD dirrectiive (s). 甲方應(yīng)對(duì)其其產(chǎn)品安全全特性負(fù)責(zé)責(zé),保持CCE認(rèn)證時(shí)時(shí)質(zhì)量水平平。當(dāng)乙方方發(fā)現(xiàn)甲方方產(chǎn)品在歐歐盟市場(chǎng)不不滿足指令令要求或有有關(guān)法律要要求時(shí),應(yīng)應(yīng)通知甲方方須改進(jìn)內(nèi)內(nèi)容,由甲甲方負(fù)責(zé)處處理; 5. Thhe fiirst partty iss re

13、ssponssiblee forr thee preeparaationn of the “Decclaraationn of Confformiity” accoordinng too thee apppliedd Dirrectiive aand tthe ffirstt parrty sshoulld keeep tthe ssubmiittedd Tecchniccal (Consstrucctionn) Fiile ffor 110 yeears. 甲方應(yīng)應(yīng)根據(jù)指令令要求發(fā)布布符合性聲聲明,并保保留符合性性聲明和技技術(shù)文件110年; 6. Thhe fiirst partty haa

14、s thhe riight to uuse iits CCE maark aaccorrdingg to the defiined requuiremmentss andd dirrectiives, andd hass thee rigght tto prromotte itts CEE reggistrratioon too thee pubblic corrrectlly affter the acquuisittion of tthe ccertiificaate. 在獲得CEE證書后,甲甲方具有按按規(guī)定正確確使用CEE認(rèn)證標(biāo)記記的權(quán)利和和對(duì)外正確確宣傳產(chǎn)品品認(rèn)證注冊(cè)冊(cè)資格的權(quán)權(quán)利;

15、7. Thhe fiirst partty shhall notiifyinng thhe seecondd parrty aagainnst mmajorr cusstomeer coomplaains and any signnificcant channges in qqualiity ssysteem, wworkiing pproceess, majoor prroducctionn equuipmeent, prodduct speccificcatioon annd keey suuppliiers. 甲方應(yīng)將重重大客戶投投訴及在質(zhì)質(zhì)量體系、工藝、生生產(chǎn)設(shè)備和和關(guān)鍵供貨貨商發(fā)生重

16、重大變化時(shí)時(shí)通報(bào)乙方方; 8. Thhe fiirst partty shhall infoorm tto thhe seecondd parrty ffor tthe cchangges oof itts prroducct sccopess. Thhe seecondd parrty ddeciddes wwhethher oor noot too carrry oout rreasssessmment or pproduuctioon innspecctionn. 甲方要求變變更其認(rèn)證證范圍時(shí)必必須向乙方方提出申請(qǐng)請(qǐng),由乙方方?jīng)Q定是否否重新進(jìn)行行產(chǎn)品審核核或檢驗(yàn); 9. Thhe fii

17、rst partty shhall obliige tthe rrequeestedd asssessmment set by tthe sseconnd paarty and provvide neceessarry asssisttancee, whhen oon-siite aassesssmennt iss neccessaary aaccorrdingg to certtificcatioon prroceddure. 甲方有義務(wù)務(wù)遵守乙方方認(rèn)證程序序和要求,配配合乙方工工作,包括括按照認(rèn)證證行業(yè)規(guī)定定,乙方到到甲方進(jìn)行行現(xiàn)場(chǎng)評(píng)審審時(shí),甲方方應(yīng)給與協(xié)協(xié)助; 10. DDurinng

18、coo-opeeratiion, whenn terrminaate tthe pprojeect ddue tto fiirst partty, ffirstt parrty sshalll makke paaymennt inn terrms oof prrogreess oof thhe prrojecct; wwhen termminatte thhe prrojecct duue too seccond partty, ffirstt parrty oowns righht off reccoursse. 項(xiàng)目合作過過程中,因因甲方原因因中止項(xiàng)目目時(shí),甲方方應(yīng)按項(xiàng)目目進(jìn)展程度度支付款

19、項(xiàng)項(xiàng);因乙方方原因中止止項(xiàng)目時(shí),乙乙方應(yīng)賠付付給甲方造造成的直接接和間接損損失,同時(shí)時(shí)甲方擁有有追索權(quán); 11. DDurinng thhe peeriodd of valiidityy, thhe fiirst partty shhouldd acccept survveilllancee auddit wwithiin thhe daate oone mmonthh beffore the certtificcate issuuing. If theyy reffuse to aacceppt thhe suurveiillannce aauditt, thhe seecondd parr

20、ty wwill canccel tthe ccertiificaate. And the firsst paarty shouuld rreturrn thhe orriginnal ccertiificaate tto thhe seecondd parrty. 在證書有效效期內(nèi),甲甲方應(yīng)在每每年證書頒頒發(fā)日期前前一個(gè)月內(nèi)內(nèi)接受年審審;如拒不不接受年審審,乙方將將撤銷該證證書,甲方方應(yīng)返還該該證書原件件。 3 of 6 Reegisttratiion NNumbeer Off Conntracct 合同同登記編號(hào)號(hào): CEE-0900826-01 四. Riight And Obliiga

21、tiion oof thhe Seecondd Parrty 乙乙方的權(quán)利利和義務(wù)1. Whhen tthe ccontrract signned tthe sseconnd paarty has to pproviide tthe iindexx of direectivve(s) andd staandarrd(s) to the firsst paarty for confformiity aassesssmennt. 自本合同簽簽訂之日起起,乙方負(fù)負(fù)責(zé)組織認(rèn)認(rèn)證工作需需要的指令令和標(biāo)準(zhǔn)目目錄(中文文),并將將此目錄正正式提交給給甲方; 2. Siince the datee wheen

22、 thhe coontraact iis siignedd, thhe seecondd parrty hhas rrespoonsibbilitty too forrwardd thee lisst off tecchniccal ffile for confformiity aassesssmennt. 自本合同簽簽訂之日起起,乙方負(fù)負(fù)責(zé)向甲方方提供認(rèn)證證所需要的的技術(shù)文件件清單(中中文); 3. Thhe seecondd parrty sshalll arrrangee commpeteent ttechnnicall perrsonnnel bbasess on the needds

23、 off connformmity asseessmeent, the appoointeed asssesssmentt teaam shhouldd subbmit quesstionns obbjecttivelly annd prractiicallly, aand ddeal withh rellativve quuestiions in pproceess oof coonforrmityy asssessmment justtly aand sscienntifiicallly. 乙方根據(jù)認(rèn)認(rèn)證工作需需要配備有有能力的專專業(yè)技術(shù)人人員,乙方方指定的審審核組應(yīng)客客觀、實(shí)事事求是地提

24、提出問題并并公正、科科學(xué)地處理理審核中的的有關(guān)問題題; 4. Thhe seecondd parrty sshalll proovidee thee asssessmment repoort ttogetther withh nonn-commpliaance notiice tto thhe fiirst partty foor coorrecctivee acttionss. 乙方應(yīng)該提提交評(píng)審報(bào)報(bào)告及不合合格通知以以便甲方進(jìn)進(jìn)行整改; 5. Thhe seecondd parrty sshalll revview the asseessmeent cconcllusioon inniti

25、aally, andd forrwardd rellativve innformmatioon too heaad offficee forr finnal aassesssmennt. TThe sseconnd paarty shouuld nnoticce thhe cooncluusionn to the firsst paarty in 33 worrkingg dayys onnce ggets the resuult. 乙方將認(rèn)證證的結(jié)論進(jìn)進(jìn)行初步評(píng)評(píng)審,初審審?fù)ㄟ^后,將將有關(guān)的資資料送交乙乙方總部進(jìn)進(jìn)行最終評(píng)評(píng)審,取得得評(píng)審結(jié)果果后在三個(gè)個(gè)工作日內(nèi)內(nèi)通知甲方方; 6. Thhe

26、 seecondd parrty sshalll carrry oout tthe aassesssmennt foor prroducct acccordding to tthe rrequiiremeent oof diirecttive, to veriify tthe llegall acccess of pproduuct tto thhe EUU marrket. 乙方按照歐歐盟產(chǎn)品指指令要求對(duì)對(duì)產(chǎn)品進(jìn)行行評(píng)審,合合格后確認(rèn)認(rèn)甲方產(chǎn)品品具備進(jìn)入入歐盟市場(chǎng)場(chǎng)資格; 7. Seecondd parrty aassesss thhe teechniical docuumentt andd

27、 sysstem for the appllied prodduct by ffirstt parrty aaccorrdingg to thiss conntracct. IIf thhe teechniical consstrucctionn fille off thee apppliedd prooductt andd appplicaable testts meeet tthe rrequiiremeents of aappliicablle EUU Dirrectiive aand aappliicablle sttandaards of ttestiing, the firsst

28、paarty shouuld iissuee cerrtifiicatee by ITC. 乙方根據(jù)合合同規(guī)定對(duì)對(duì)甲方申請(qǐng)請(qǐng)的產(chǎn)品提提供CE申請(qǐng)和和技術(shù)文件件評(píng)審,按按照歐盟相相關(guān)指令的的要求確認(rèn)認(rèn)甲方技術(shù)術(shù)文件和產(chǎn)產(chǎn)品經(jīng)相關(guān)關(guān)檢測(cè)合格格后,為甲甲方發(fā)放IITC評(píng)審審的CE認(rèn)證證證書。五. Coonfiddentiialitty 保密密條款The sseconnd paarty shalll noot giive iinforrmatiion tto anny thhird partty reegardding the prodductiion aand ttechnnicall datta

29、off thee firrst ppartyy in any formms, wwith the folllowinng exxcepttion. If not, thee seccond partty shhouldd payy thee dammagess to firsst paarty. 乙方不得將將甲方經(jīng)營(yíng)營(yíng)、生產(chǎn)狀狀況及技術(shù)術(shù)信息以任任何方式向向第三方泄泄漏,但下下列情況除除外。若乙乙方違反前前述保密條條款,乙方方應(yīng)賠付給給甲方造成成的直接和和間接損失失。1. Innformmatioon obbtainned bby thhe seecondd parrty bbeforre s

30、iigninng off thiis coontraact. 此合同簽署署前乙方收收到的信息息; 4 of 6 Reegisttratiion NNumbeer Off Conntracct 合同同登記編號(hào)號(hào): CEE-0900826-01 2. Anny innformmatioon whhich is llawfuully partt of the publlic ddate. 甲方在認(rèn)證證范圍外已已公開的資資料; 3. Leegal acceess hhas bbeen obtaainedd. 法律另有要要求時(shí); 4. Thhe auuthorrity has suchh demmand

31、. 國(guó)家主管部部門要求時(shí)時(shí)。六. Thhe ammendmment and canccellaationn of the conttractt 合同的的變更和解解除Afterr thee conntracct gooing intoo efffect, thee firrst ppartyy andd thee seccond partty shhouldd strrictlly caarry out the obliigatiions accoordinng too thee conntracct. AAny ppartyy cannnot termminatte orr ameend tt

32、he ccontrract on iits oown; the two partties mustt neggotiaate aand rreachh thee agrreemeent tto coompleementt, ammend and termminatte thhe coontraact wwhen neceessarry. 合同生效后后,甲乙雙雙方均應(yīng)嚴(yán)嚴(yán)格按照本本合同條款款履行義務(wù)務(wù),任何一一方不得單單獨(dú)終止、修改本合合同;如需需補(bǔ)充、修修改和終止止合同,須須經(jīng)雙方協(xié)協(xié)調(diào)一致達(dá)達(dá)成共識(shí)后后進(jìn)行。七. Seettleementt of Dispputess 爭(zhēng)議處處理All tt

33、he iitemss of thiss conntracct arre coompliied wwith the lawss andd reggulattionss of the PRC. Dissputees caausedd by thiss conntracct shhouldd be firsstly solvved bby frrienddly nnegottiatiion bbetweeen tthe ffirstt parrty aand tthe sseconnd paarty. Unssolveed diisputtes ccan bbe soolvedd by the folllowinng appproaachedd

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