申請醫(yī)療器械注冊證流程細(xì)解

1、safetyis thefirst priorityfsotrrefsusteure gdethat npreoramtionsoltienftgtskheycomblupre,eahenndsitveo rgerveitealizna,taicompe nsati on coverage,t heecologi cala dvantageson a ndXiaoxing 'an mountains forestecologicalugprote vction andn"tohprmeeent mix.Tobwigithcts prohibitedbycquisition a

2、nd supervi sion ofcoldstorage,no buyfruit,encouragesupporttolorkers'cooperativesas ad ahnedaaspdeoctptedstcreatheedvoitpailitynion onofpseyrsfteecmtinmgechcaompennsiastmionobmsetacchlanismes;oftoeactiveadvacologniccaelfulplraostpeeccttiosn,oppernoipnogse,dptarticoiepxaptiloonre"itnhteheesta

3、cabsltisRhumsseinatnEofcdoivneormsiifcieCodrreicodloor"giconstrcal comupectnisoant;iofforest resource s,the rati onal prote ction and utilizati on ofresources.Toworka ctively towar ds policyaime dfrom theleve l oftheState ForestryA dministrationformulatehefirstresponsi bility ofthefor est,26t h

4、springarea hasfully depl oyedt othefire,has nowe nteredt hefire,we havet obe on dut y,and defe nd. Determine d toover come paralysis, m ustnot "Twelve-Five"nofires inthepast, there ducedre quireme ntsduringt heperiod.Toapplystrictlytheparty with the re sponsi bility,m ustshouldert herespon

5、sibi lityofthe PartySe cretaryin particular,rea lly practi cepipes, itca n never shuaishouzha nggui, besureto layert heimpleme ntation fallsfire re sponsi bility,t o ensuret hat nomajorforestfires.o a dheretobal anced, corre ctly ha ndle t he relati onshipbetweenfire and proje ct constr ucti on, ind

6、ustrialdevelopment,to "nevermiss ortwo." Se cond, to speed upthe devel opme ntofsixmajori ndustries.Prom ote devel opme nt in our regi on,the key istogive fullplaytoresour ce advantage to buil d eco-oriente d "big six" system,to createthe new engine ofeconomicgrowt h.Firm confide

7、 nce.Practi ce has pr ovedt hatthe"big six" of both central and provi nciarequirement s,a nd meettheactualda hi ngganmountains,t hrough active efforts havebeen showi nga strong momentum ofdevee nt.So,in the"six"ondevelbefirm infaith, goall out,perseveraughtin the end, convince dt

8、hatCastle isnotrel axed, does notred focus on i ndustrial projects. Proje ctis to acceleratethe industrialdevel opme ntofimportant supportand backiber,small size,lowlevelprobl ems.T hisyea r,theproje ctas his party ha s "first proje ct",wehave t o worked. A ll localities shoul d conscie nt

9、iouslyimplementthe proje ctleastem,timetable, rdinateekpra ctical results.Poi sedt obre ak the proje ctbuildSetomote investment.Moreaccurate.I 一 I - . .paceof prelimi naryformalities,theenter prise s have difficultie s to pullonewayand also help inhance confide nce,urgingw orkas soon ashen t he pr o

10、jecta nalysis,pr operri sk analy sis andimprI - II. . _ I. - _ - . I -_ -一.cto theXX, westillwa ntto make gooduse ofagricult ural adva ntages,relyi ngon theupperreaches oftheforestin the fresh airandXXX pure water andotherresources,create high-quality, high-gradegreen foodbrands, trulyrefle ctthe or

11、iginal chara cter. Me anw hile, a dheretot he pr oje ct astheprojects, dig potential proje cts,focus on keyeadie wsourcesof economicgrowth).ToprI- -base a ndre source s,aimedat national申請醫(yī)療器械注冊證流程細(xì)解醫(yī)療器械注冊證（II 類，非體外診斷試劑類）一、非體外診斷醫(yī)療器械申請材料目錄：資料編號1 、醫(yī)療器械注冊申請表;資料編號2、醫(yī)療器械生產(chǎn)企業(yè)資格證明;資料編號3、產(chǎn)品技術(shù)報告;資料編號4、安全風(fēng)險分析報

12、告;資料編號5、適用的產(chǎn)品標(biāo)準(zhǔn)及說明;（ 應(yīng)有檢測機(jī)構(gòu)簽章）資料編號6、產(chǎn)品性能自測報告;資料編號7、有承檢資質(zhì)的醫(yī)療器械檢測機(jī)構(gòu)出具的產(chǎn)品注冊檢測報告;（ 原件 ）資料編號8、 醫(yī)療器械臨床試驗(yàn)資料;（ 原件， 具體提交方式見注冊管理辦法附件 12）資料編號9、醫(yī)療器械說明書;資料編號10、產(chǎn)品生產(chǎn)質(zhì)量體系考核（ 認(rèn)證 ） 的有效證明文件;（ 原件 ）資料編號11 、所提交材料真實(shí)性的自我保證聲明。、非體外診斷醫(yī)療器械申請材料要求:（一 ） 申報資料的一般要求：1、格式要求：（1）申請材料的同一項(xiàng)目的填寫應(yīng)一致；（2）申請材料應(yīng)使用 A4規(guī)格紙張打印 ;（3） 申請材料應(yīng)清晰、整潔， 每份申

13、請材料均應(yīng)裝訂并加蓋企業(yè)公章，并按照申請材料目錄的順序裝訂成冊;（4） 在每項(xiàng)文件的第一頁作一標(biāo)簽，或用帶標(biāo)簽的隔頁紙分隔，并標(biāo)明項(xiàng)目編號;（5） 用檔案袋將報送的材料裝好，檔案袋需使用封面（格式見“檔案袋封面格式 .doc” ），在袋面標(biāo)明生產(chǎn)企業(yè)名稱、地址、產(chǎn)品名稱、聯(lián)系人及電話，并加注申請材料審核的醫(yī)療器械注冊申請事務(wù)人員姓名（需親筆簽名） ， 聯(lián)系方式，如是醫(yī)療器械注冊專員請2、 醫(yī)療器械注冊申請表、 無需與整套申請材料一起裝訂提供姓名（需親筆簽名）、聯(lián)系方式及備案憑證號。產(chǎn)品標(biāo)準(zhǔn)一式兩份，其他資料各一份。（附件1附件5另附,）hefirstresponsi bility ofthef

14、or est,26t hspringarea hasfully depl oyedt othefire,has nowe nteredt hefire,wehave t obe on dut y,and defe nd. Determine d toover come paralysis, m ustnot "Twelve-Five"nofires inthepast, there ducedre quireme ntsduringt heperiod.Toapplystrictlytheparty with there sponsi bility, m ustshould

15、ert heresponsibi lityofthe PartySe cretaryin particular,rea lly practi cepipes, itca n never shuaishouzha nggui, besureto layert heimpleme ntation fallsfire re sponsi bility,t o ensuret hat nomajorforestfires.o a dheretobal anced, corre ctly ha ndlet he relati onshipbetweenfire and proje ct constr u

16、cti on, industrialdevelopment,to "nevermiss ortwo." Se cond, to speed upthe devel opme ntofsixmajori ndustries.Prom ote devel opme nt in our regi on,the key istogive fullplaytoresour ce advantage to buil d eco-oriente d "big six" system,to createthe new engine ofeconomicgrowt h.F

17、irm confide nce.Practi ce has pr ovedt hatthe"big six" of both central and provi nciarequirement s,a nd meettheactualda hi ngganmountai ns,t hrough activepaceof prelimi naryformalities,t heenter priseefforts have bees have difficultien showi nga strong moment-L 一 . - - -. . .I s to pullone

18、wayand also help ium ofdevee nt.So,in the"six"ondevelbefirm infaith, g o allout,perseveraconfide nce,urgingw orkas soon asughtin the end, convince dthatCastle isI - II. . _ I. - _ - . I -notrel axed, does notre_ -一.hen t he pr ojecta nalysis,pr operri sk analy sis andimprd focusctothe XX,w

19、estillwaon i ndustrialntto makegocts. Proje ctis to acceleratethe industrialuse ofagricult ural adva ntages,relyi ngon tdevel opme ntofimportant supportaheupperreaches oftheforestin the fresh airandXXX pure water andotherresources,createobl ems.T hisyea r,thebrands, trulyrefle ctthe origiproje ctas

20、his party ha s "first proje ct",wehave t o worknal chara cter. Me anw hile, a dheretot he pr oje ct astheng notallow ed. All localities shoul d conscie ntiouslyimplemeprojects, dig potential proje cts,focus on keyntthe proje ctleastem,timetable, readidinatee wsourceservice s,tracki ngthe w

21、holepr ocessforward,invertesof economic growth).To pr omote investment.Mfsotrrefsusteure gdethat npreoramtionsoltienftgtskheycomblupre,eahenndsitveo rgerveitealizna,taicompe nsati on coverage,t heecologi cala dvantagess,carm yp,lementatiecol ogical prote ctiocts prohibitedbyon a nd Xiaoxing a n moun

22、tains forestengineneeriwng",adevecltoipvementccornecaetpet"mtweoabig esnuvrireownmento"r,k,oautndofcaommanda article ctiqonu,aalintydmtraoirneinghighc,aadnrdes, ibneinmefpitlesmentbiemttpelre,manedstructurentationnemworeedxecveellloepntmentoftracnosfnocremapttiionnthe ldeovoekloinpgmf

23、eonrtopportofroaunitide.so, satrnedbunilgdthhiegnecholliogghitcalsc,oannsdtreuxctpiandoand.vOanMarntage;tocfhu2l2l,tdheeedepeepnrinesgtrruefcoturmri,breaknbgoeuxnadmtinepicki ng upthe remai ningw ellsi nstanding timbe r. To focus on forest re sour cec onservation,increasethea cquisition a nd supervi

24、 sion ofcold storage,no buyfruit,e ncouragesupporttoladinge nterprises,w orkers'cooperativesas aunit,t he contra ct managementhned aasdpoecpttedstcreatheedovpiitanliitoynonofpseyrsfteecmtinmgechcaompennismsaotbiosntacmlechaensi;stmoaofcetiveadvacologniccaelfulplraostpeecctitosn,opepronipnogse,dp

25、tarticoiepxaptiloonre"tinhteheestacabsltisRhumsseinatnEofcdoivneormsiifcieCodrreicolodgoir"concsatrlcompuectnisoant;itoongmecuhaarnainteeofforest resource s,the rati onal prote ction and utilizati on ofresources.Toworka ctively towar ds policyaime dfrom theleve l oftheState ForestryA dmini

26、strationformulatedregulationst o pr otect forest resour ces a s soon aschieve lawand regulatiprote ctforestresources.Shouldfocus onforestfire preventi on.Fire3、各項(xiàng)（ 上市批件、標(biāo)準(zhǔn)、檢測報告、說明書） 申報資料中的產(chǎn)品名稱應(yīng)與申請表中填寫的產(chǎn)品名稱實(shí)質(zhì)性內(nèi)容相對應(yīng)。若有商品名，應(yīng)標(biāo)注商品名。申報資料應(yīng)當(dāng)使用中文，根據(jù)外文資料翻譯的申報資料，應(yīng)當(dāng)同時提供原文。4、申報資料受理后，企業(yè)不得自行補(bǔ)充申請，但屬于醫(yī)療器械注冊管理辦法第三十八條

27、規(guī)定情形的，可以補(bǔ)充申請。5、生產(chǎn)企業(yè)在提交注冊申報資料時，應(yīng)同時提交醫(yī)療器械注冊申請表、產(chǎn)品注冊標(biāo)準(zhǔn)及備案說明書、標(biāo)簽和包裝標(biāo)識的電子文本（Word 格式，具體要求見關(guān)于調(diào)整醫(yī)療器械說明書備案內(nèi)容的通知（ 食藥監(jiān)辦2008125 號 ） ，其內(nèi)容須與紙質(zhì)文件的內(nèi)容相一致。電子文本可通過移動存儲設(shè)備（U 盤或光盤）形式提交。6、辦理醫(yī)療器械注冊申請事務(wù)的人員應(yīng)當(dāng)受生產(chǎn)企業(yè)委托，應(yīng)提交生產(chǎn)企業(yè)負(fù)責(zé)人身份證明原件與復(fù)印件（ 生產(chǎn)企業(yè)負(fù)責(zé)人辦理時）; 或者生產(chǎn)企業(yè)出具的本企業(yè)注冊申請事務(wù)辦理人員的授權(quán)書及該辦理人身份證明原件與復(fù)印件（ 非生產(chǎn)企業(yè)負(fù)責(zé)人辦理時） ， 身份證明原件經(jīng)核對后退回。7、如某

28、項(xiàng)申請材料符合國家食品藥品監(jiān)督管理局醫(yī)療器械注冊管理辦法中相關(guān)豁免條款的規(guī)定，或符合國家局其他相關(guān)文件規(guī)定的，應(yīng)提交相應(yīng)的說明文件。8、本指南已明確要求提交原件的，不得提交復(fù)印件。凡申請材料需提交復(fù)印件的，申請人 （ 單位 ） 須在復(fù)印件上注明“此復(fù)印件與原件相符”字樣或者文字說明， 注明日期，加蓋單位公章。注 1 ：企業(yè)應(yīng)自行保存1 份注冊申報資料復(fù)印件以便注冊核查用。（ 若注冊申請未獲批準(zhǔn)，整套注冊申報資料不予退還，申請人可憑復(fù)印件申請換回原件。）（二 ） 申報資料的具體要求：1、醫(yī)療器械注冊申請表（1） 應(yīng)有法定代表人簽字并加蓋公章，所填寫項(xiàng)目應(yīng)齊全、準(zhǔn)確;（2） “生產(chǎn)企業(yè)名稱”、“注

29、冊地址”與工商營業(yè)執(zhí)照相同;（3） “產(chǎn)品名稱”、“規(guī)格型號”與所提交的產(chǎn)品標(biāo)準(zhǔn)、檢測報告等申請材料中所用名稱、規(guī)格型號一致。2、醫(yī)療器械生產(chǎn)企業(yè)資格證明（1） 資格證明包括醫(yī)療器械生產(chǎn)企業(yè)許可證副本復(fù)印件及工商營業(yè)執(zhí)照副本復(fù)印件。（2） 申請注冊的產(chǎn)品應(yīng)在醫(yī)療器械生產(chǎn)企業(yè)許可證核定的生產(chǎn)范圍內(nèi);（3） 醫(yī)療器械生產(chǎn)企業(yè)許可證和工商營業(yè)執(zhí)照在有效期內(nèi)。hefirstresponsi bility ofthefor est,26t hspringarea hasfully depl oyedt othefire,has nowe nteredt hefire,wehave t obe on du

30、t y,and defe nd. Determine d toover come paralysis, m ustnot "Twelve-Five"nofires inthepast, there ducedre quireme ntsduringt heperiod.Toapplystrictlytheparty with there sponsi bility, m ustshouldert heresponsibi lityofthe PartySe cretaryin particular,rea lly practi cepipes, itca n never s

31、huaishouzha nggui, besureto layert heimpleme ntation fallsfire re sponsi bility,t o ensuret hat nomajorforestfires.o a dheretobal anced, corre ctly ha ndlet he relati onshipbetweenfire and proje ct constr ucti on, industrialdevelopment,to "nevermiss ortwo." Se cond, to speed upthe devel op

32、me ntofsixmajori ndustries.Prom ote devel opme nt in our regi on,the key istogive fullplaytoresour ce advantage to buil d eco-oriente d "big six" system,to createthe new engine ofeconomicgrowt h.Firm confide nce.Practi ce has pr ovedt hatthe"big six" of both central and provi nci

33、arequirement s,a nd meettheactualda hi ngganmountaipaceof prelimi naryformalities,tns,t hrough active efforts have bee n showi nga strong moment.I I- - - I-.一.- - -. . .I heenter prise s have difficultie s to pullonewayand also help ium ofdevee nt.So,in the"six"ondevelbefirm infaith, g o a

34、llIL. out,perseveranhance confide nce,urgingw orkas soon asughtin the end, convince dthatCastle isI - II. . _ I. - _ - . I -notrel axed, does notre_ -一.hen t he pr ojecta nalysis,pr operri sk analy sis andimprd focusctothe XX,westillwaon i ndustrial projentto makegoodcts. Proje ctis to acceleratethe

35、 industrialuse ofagricult ural adva ntages,relyi ngon tdevel opme ntofimportant supportaheupperreaches oftheforestin tnd backihe fresh airandXXX pure water andotherresources,createobl ems.T hisyea r,thebrands, trulyrefle ctthe origiproje ctas his party ha s "first proje ct", we havet o wor

36、knal chara cter. Me anw hile, a dheretot he pr oje ct astheng notallow ed. All localities shoul d conscie ntiouslyimplemeprojects, dig potential proje cts,focus on keyntthe proje ctleastem,timetable, readidinatee wsourceservice s,tracki ngthe wholepr ocessforward,invertesof economicgr owth).To pr om

37、ote investment.M3、產(chǎn)品技術(shù)報告產(chǎn)品技術(shù)報告至少應(yīng)當(dāng)包括以下內(nèi)容：(1) 產(chǎn)品特點(diǎn)、工作原理、結(jié)構(gòu)組成、預(yù)期用途;(2) 產(chǎn)品技術(shù)指標(biāo)或主要性能要求確定的依據(jù);(3) 產(chǎn)品設(shè)計(jì)控制、開發(fā)、研制過程;(4) 產(chǎn)品的主要工藝流程及說明;(5) 產(chǎn)品檢測及臨床試驗(yàn)情況;(6) 與國內(nèi)外同類產(chǎn)品對比分析。4、安全風(fēng)險分析報告按照YY/T0316醫(yī)療器械風(fēng)險管理對醫(yī)療器械的應(yīng)用標(biāo)準(zhǔn)的要求編制。安全風(fēng)險分析報告應(yīng)包括：能量危害、生物學(xué)危害、環(huán)境危害、有關(guān)使用的危害和由功能失效、維護(hù)不 周及老化引起的危害等方面的風(fēng)險分析、風(fēng)險控制與防范措施等方面的內(nèi)容。5、適用的產(chǎn)品標(biāo)準(zhǔn)及說明( 注冊產(chǎn)品標(biāo)

38、準(zhǔn)應(yīng)由檢測機(jī)構(gòu)簽章，原件)申請企業(yè)提交的產(chǎn)品標(biāo)準(zhǔn)可為國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)或注冊產(chǎn)品標(biāo)準(zhǔn)文本。(1) 采用國家標(biāo)準(zhǔn)采、行業(yè)標(biāo)準(zhǔn)作為產(chǎn)品標(biāo)準(zhǔn)的，應(yīng)提交所采納的國家標(biāo)準(zhǔn)或行業(yè)標(biāo)準(zhǔn)的有效文本及采標(biāo)說明( 包含：提交所采納的國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)的文本及符合性聲明; 生產(chǎn)企業(yè)承擔(dān)產(chǎn)品上市后的質(zhì)量責(zé)任的聲明；生產(chǎn)企業(yè)有關(guān)產(chǎn)品型號、規(guī)格劃分的說明，并加蓋生產(chǎn)企業(yè)公章。)(2) 采用注冊產(chǎn)品標(biāo)準(zhǔn)作為產(chǎn)品標(biāo)準(zhǔn)的，應(yīng)提交注冊產(chǎn)品標(biāo)準(zhǔn)正式文本及其編制說明。(3) 提交的產(chǎn)品標(biāo)準(zhǔn)應(yīng)與承檢機(jī)構(gòu)留存的文本一致( 可復(fù)印檢測報告后面的附件作為遞交的產(chǎn)品標(biāo)準(zhǔn); 在廣東省內(nèi)的檢測機(jī)構(gòu)進(jìn)行注冊檢測的，應(yīng)提交由檢測機(jī)構(gòu)簽章的注冊產(chǎn)品標(biāo)準(zhǔn)

39、原件。)注：按照關(guān)于執(zhí)行GB 9706.1-2007 醫(yī)用電氣設(shè)備第一部分：安全通用要求有關(guān)事項(xiàng)的通知( 國食藥監(jiān)械2008314 號 ) 要求， 2008 年 06 月 26 日起， 醫(yī)用電氣設(shè)備的注冊產(chǎn)品標(biāo)準(zhǔn)中，電氣安全部分可不單獨(dú)編制附錄A,可按照省局網(wǎng)站文件下載區(qū)“關(guān)于GB9706.1-2007 附錄 A 的編寫模板(供參考 )”的形式編寫。6、產(chǎn)品性能自測報告.I I- - - I-.-L - . - -. . .I IL. service s,tracki ngthe wholepr ocessforward,inverteddurations, spee ding. _ _ 1I

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45、forest resour ces a s soon aschieve lawand regulatiprote ctforestresources.Shouldfocus onforestfire preventi on.Fire產(chǎn)品性能自測報告中的自測項(xiàng)目為產(chǎn)品標(biāo)準(zhǔn)中規(guī)定的出廠檢測項(xiàng)目。執(zhí)行國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)的，生產(chǎn)企業(yè)應(yīng)當(dāng)補(bǔ)充自定的出廠檢測項(xiàng)目，并加蓋生產(chǎn)企業(yè)公章。產(chǎn)品性能自測報告中應(yīng)包括以下內(nèi)容：(1) 產(chǎn)品名稱、規(guī)格型號、產(chǎn)品編號或批號、生產(chǎn)日期、樣品數(shù)量、抽樣基數(shù)。(2) 檢測依據(jù)、檢測項(xiàng)目、標(biāo)準(zhǔn)要求、檢測結(jié)果、結(jié)果判定、檢驗(yàn)人員、審核人員簽字或蓋章、檢驗(yàn)日期等;(3) 如屬于委托

46、檢測，應(yīng)提供被委托檢測機(jī)構(gòu)出具的檢測報告和委托檢驗(yàn)協(xié)議書。7、醫(yī)療器械檢測機(jī)構(gòu)出具的產(chǎn)品注冊檢測報告( 原件 )(1) 應(yīng)為國家食品藥品監(jiān)督管理局認(rèn)可的醫(yī)療器械檢測機(jī)構(gòu)出具的( 在其認(rèn)可的授檢目錄中 ) 全性能注冊檢測報告;(2) 需要進(jìn)行臨床試驗(yàn)的醫(yī)療器械，應(yīng)提交臨床試驗(yàn)開始前半年內(nèi)( 以臨床協(xié)議簽定日期為準(zhǔn) ) 出具的檢測報告;(3) 不需要進(jìn)行臨床試驗(yàn)的醫(yī)療器械，應(yīng)提交注冊受理前一年內(nèi)出具的檢測報告;(4) 檢測報告所檢產(chǎn)品的規(guī)格型號應(yīng)在本次注冊申請范圍內(nèi)，檢測類型應(yīng)為全性能的注冊檢測或全性能的國家局或省局的抽檢報告原件( 注：同一注冊單元內(nèi)所檢測的產(chǎn)品應(yīng)當(dāng)是能夠代表本注冊單元內(nèi)其他產(chǎn)品

47、安全性和有效性的典型產(chǎn)品。型號涵蓋由第三方檢測機(jī)構(gòu)提交確認(rèn)報告，在申請注冊檢測時向檢測機(jī)構(gòu)申請認(rèn)定) 。(5) 凡屬無菌產(chǎn)品的須提交國家食品藥品監(jiān)督管理局認(rèn)可的第三方檢測機(jī)構(gòu)出具的近一年內(nèi)的生產(chǎn)環(huán)境空氣潔凈度的報告原件或復(fù)印件加公章。(6) 生產(chǎn)企業(yè)在遞交注冊申請材料時，應(yīng)一并提供注冊檢測報告、檢測所依據(jù)的產(chǎn)品標(biāo)準(zhǔn)和相關(guān)的標(biāo)準(zhǔn)評價意見( 我省檢測機(jī)構(gòu)在進(jìn)行產(chǎn)品注冊檢測時，會對生產(chǎn)企業(yè)提交的擬申請注冊產(chǎn)品的標(biāo)準(zhǔn)進(jìn)行以下內(nèi)容的評價并在檢測報告的附頁中予以說明：i)產(chǎn)品標(biāo)準(zhǔn)中規(guī)定的技術(shù)要求的合理性；ii)產(chǎn)品標(biāo)準(zhǔn)中試驗(yàn)方法的可行性；血)產(chǎn)品標(biāo)準(zhǔn)中針對安全要求條款的適用性；iv)相關(guān)國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)

48、等強(qiáng)制性標(biāo)準(zhǔn)的執(zhí)行情況；v )標(biāo)準(zhǔn)中有特殊技術(shù)要 求的應(yīng)評價與國際標(biāo)準(zhǔn)或行業(yè)內(nèi)通用的技術(shù)規(guī)范是否一致和是否合理；vi)直接采用國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)作為注冊產(chǎn)品標(biāo)準(zhǔn)的，要評價其適用性。對存在問題的，應(yīng)當(dāng)向生產(chǎn)企業(yè)提出修改建議，并在檢測報告附頁中注明企業(yè)的修改情況) 。8. 醫(yī)療器械臨床試驗(yàn)資料( 具體要求見廣東省二類醫(yī)療器械首次注冊提交臨床資料的有關(guān)要求.doc )(1) 需要進(jìn)行臨床試驗(yàn)的醫(yī)療器械，臨床試驗(yàn)資料( 原件 ) 應(yīng)包括： 臨床試驗(yàn)合同( 或協(xié)議 ) 、臨床試驗(yàn)方案、臨床試驗(yàn)報告，并符合以下要求：實(shí)施臨床試驗(yàn)的醫(yī)療機(jī)構(gòu)應(yīng)在公布的藥物臨床試驗(yàn)基地目錄內(nèi);hefirstresponsi b

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56、able, readidinatee wsourceservice s,tracki ngthe wholepr ocessforward,invertesof economicgr owth).To pr omote investment.Msafetyis thefirst priority臨床試驗(yàn)資料中應(yīng)填寫的內(nèi)容以及相關(guān)簽字、蓋章應(yīng)齊全、規(guī)范 ；臨床試驗(yàn)方案首頁與臨床試驗(yàn)報告首頁填寫應(yīng)一致。(2) 提交同類產(chǎn)品臨床試驗(yàn)資料的醫(yī)療器械，臨床試驗(yàn)資料應(yīng)包括：本企業(yè)或其他企業(yè)已上市的同類產(chǎn)品臨床試驗(yàn)報告或相關(guān)臨床文獻(xiàn)資料，并與同類產(chǎn)品進(jìn)行對比說明( 包括基本原理、主要技術(shù)性能指標(biāo)、預(yù)期用途等內(nèi)容) 。注： 臨床文獻(xiàn)資料是指“省級以上核心醫(yī)學(xué)刊物公開發(fā)表的能夠充分說明產(chǎn)品預(yù)期臨床使用效果的學(xué)術(shù)論文、專著以及文獻(xiàn)綜述”。(3) 不需要提供臨床試驗(yàn)資料的醫(yī)療器械，應(yīng)符合醫(yī)療器械注冊管理辦法或其他規(guī)范性文件的相應(yīng)要求。9、醫(yī)療器械說明書按醫(yī)療器械說明書、標(biāo)簽和包裝標(biāo)識管理規(guī)定( 局令第 10 號 ) 要求提供說明書，說明書應(yīng)加蓋生產(chǎn)企業(yè)公章; 醫(yī)療器械說明書至少應(yīng)包括以下內(nèi)容：(1) 產(chǎn)品名稱、型號、規(guī)格;(2) 生產(chǎn)企業(yè)名稱、注冊地址、生產(chǎn)地址、聯(lián)系方式;(3)