體外診斷試劑注冊 中英文對照

ProvisionsforIn-vitroDiagnosticReagentRegistration體外診斷試劑注冊管理辦法(DecreeNo.5ofChinaFoodandDrugAdministration)國家食品藥品監(jiān)督管理總局令第5號TheProvisionsforIn-vitroDiagnosticReagentRegistration,adoptedattheexecutivemeetingofChinaFoodandDrugAdministrationonJune27,2014,isherebypromulgatedandshallbeeffectiveasofOctober1,2014.《體外診斷試劑注冊管理辦法》已于2014年6月27日經(jīng)國家食品藥品監(jiān)督管理總局局務(wù)會議審議通過，現(xiàn)予公布，自2014年10月1日起施行。Minister:ZhangYongJuly30,2014局長張勇2014年7月30日ProvisionsforIn-VitroDiagnosticReagentRegistration體外診斷試劑注冊管理辦法ChapterIGeneralProvisions第一章總則Article1TheProvisionsisformulatedinaccordancewiththeRegulationsonSupervisionandAdministrationofMedicalDevices,withaviewtostandardizingtheadministrationonregistrationandfilingofin-vitrodiagnosticreagentsandensuringthesafetyandeffectivenessofin-vitrodiagnosticreagents.第一條為規(guī)范體外診斷試劑的注冊與備案管理，保證體外診斷試劑的安全、有效，根據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》，制定本辦法。Article2Allin-vitrodiagnosticreagentssoldandusedwithintheterritoryofthePeople'sRepublicofChinashallapplyforregistrationorfilingaccordingtotheProvisions.第二條在中華人民共和國境內(nèi)銷售、使用的體外診斷試劑應(yīng)當(dāng)按照本辦法的規(guī)定申請注冊或者辦理案。Article3Thein-vitrodiagnosticreagentsmentionedhereinrefertoin-vitrodiagnosticreagentsadministeredasmedicaldevices,includingreagents,reagentkits,calibrators,controlmaterials,etc.forin-vitroexaminationofspecimensderivedfromhumanbodyinthecourseofdiseaseforecast,prevention,diagnosis,treatmentmonitoring,prognosisobservation,healthstatusevaluation,whichcanbeusedindependentlyorincombinationwithinstruments,devices,equipmentorsystems.第三條本辦法所稱體外診斷試劑，是指按醫(yī)療器械管理的體外診斷試劑，包括在疾病的預(yù)測、預(yù)防、診斷、治療監(jiān)測、預(yù)后觀察和健康狀態(tài)評價的過程中，用于人體樣本體外檢測的試劑、試劑盒、校準(zhǔn)品、質(zhì)控品等產(chǎn)品。可以單獨(dú)使用，也可以與儀器、器具、設(shè)備或者系統(tǒng)組合使用。

Thein-vitrodiagnosticreagentsusedforbloodscreeningandthein-vitrodiagnosticreagentslabeledbyradionuclide,whicharesubjectedtodrugadministration,donotbelongtotheadministrationscopeoftheProvisions.按照藥品管理的用于血源篩查的體外診斷試劑和采用放射性核素標(biāo)記的體外診斷試劑，不屬于本辦法管理范圍。Article4In-vitrodiagnosticreagentregistrationreferstotheprescribedproceduresconductedbythefoodanddrugregulatorydepartmentuponanapplicationsubmittedbytheregistrationapplicanttodecidewhetherthemedicaldevicetobemarketedcanbesoldbasedonacomprehensiveevaluationoftheresearchandresultsofitssafetyandeffectiveness.第四條體外診斷試劑注冊是食品藥品監(jiān)督管理部門根據(jù)注冊申請人的申請，依照法定程序，對其擬上市體外診斷試劑的安全性、有效性研究及其結(jié)果進(jìn)行系統(tǒng)評價，以決定是否同意其申請的過程。In-vitrodiagnosticreagentfilingisaprocessthatthefilingentitysubmitsthefilingdocumentstothefoodanddrugregulatorydepartmentandthefoodanddrugregulatorydepartmentfilesthefilingdocumentssubmittedbythefilingentity.體外診斷試劑備案是備案人向食品藥品監(jiān)督管理部門提交備案資料，食品藥品監(jiān)督管理部門對提交的備案資料存檔備查。Article5Thein-vitrodiagnosticreagentregistrationandfilingshallbeconductedundertheprinciplesofpublicity,equityandjustice.第五條體外診斷試劑注冊與備案應(yīng)當(dāng)遵循公開、公平、公正的原則。Article6ClassIin-vitrodiagnosticreagentsaresubjecttofilingadministrationandclassIIandclassIIIin-vitrodiagnosticreagentsaresubjecttoregistrationadministration.第六條第一類體外診斷試劑實(shí)行備案管理，第二類、第三類體外診斷試劑實(shí)行注冊管理。ToapplyforfilingofclassIin-vitrodiagnosticreagent,thefilingentityshallsubmitthefilingdocumentstothefoodanddrugregulatorydepartmentofthecityconsistingofdistricts.境內(nèi)第一類體外診斷試劑備案，備案人向設(shè)區(qū)的市級食品藥品監(jiān)督管理部門提交備案資料。ClassIIin-vitrodiagnosticreagentsshallbereviewedbythefoodanddrugregulatorydepartmentoftheprovinces,境內(nèi)第二類體外診斷試劑由省、自治區(qū)、直轄市食品藥品監(jiān)督管理部門審查，批準(zhǔn)后發(fā)給醫(yī)療器械注冊證。

autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernment,andthemedicaldeviceregistrationcertificateshallbeissuedafterapproval.ClassIIIdomesticin-vitrodiagnosticreagentsshallbereviewedbyChinaFoodandDrugAdministration,andthemedicaldeviceregistrationcertificateshallbeissuedafterapproval.境內(nèi)第三類體外診斷試劑由國家食品藥品監(jiān)督管理總局審查，批準(zhǔn)后發(fā)給醫(yī)療器械注冊證。ToapplyforfilingofimportclassIin-vitrodiagnosticreagents,thefilingentityshallsubmitthefilingdocumentstoChinaFoodandDrugAdministration.進(jìn)口第一類體外診斷試劑備案，備案人向國家食品藥品監(jiān)督管理總局提交備案資料。ImportclassIIandclassIIIin-vitrodiagnosticreagentsshallbereviewedbyChinaFoodandDrugAdministration,andthemedicaldeviceregistrationcertificateshallbeissuedafterapproval.進(jìn)口第二類、第三類體外診斷試劑由國家食品藥品監(jiān)督管理總局審查，批準(zhǔn)后發(fā)給醫(yī)療器械注冊證。Thein-vitrodiagnosticreagentsfromHongKong,MacaoandTaiwanshallberegisteredandfiledbyreferencetotheimportmedicaldevices.香港、澳門、臺灣地區(qū)體外診斷試劑的注冊、備案，參照進(jìn)口體外診斷試劑辦理。Article7Wherearegistrationapplicantorfilingentityofanin-vitrodiagnosticreagentbringstheproductstothemarketinhisownname,heshalltakeresponsibilitiesfortheproduct.第七條體外診斷試劑注冊人、備案人以自己名義把產(chǎn)品推向市場，對產(chǎn)品負(fù)法律責(zé)任。Article8Thefoodanddrugregulatorydepartmentshallpublicizerelevantinformationonin-vitrodiagnosticreagentregistrationandfilingpromptlyinaccordancewithlaws.Theapplicantcanlookuptheapprovalprogressandrelevantresultsaswellas（不能這么用）thepubliccanlookuptheresultofapproval.第八條食品藥品監(jiān)督管理部門依法及時公布體外診斷試劑注冊、備案相關(guān)信息。申請人可以查詢審批進(jìn)度和結(jié)果，公眾可以查閱審批結(jié)果。Article9TheStateencouragestheresearchandinnovationofin-vitro第九條國家鼓勵體外診斷試劑的研究與創(chuàng)新，對創(chuàng)新體外診斷試劑實(shí)行

diagnosticreagents,implementsspecialreviewforinnovativemedicaldevices,acceleratesthepopularizationandapplicationfornewtechnologiesofin-vitrodiagnosticreagentsandpromotesthedevelopmentofmedicaldeviceindustry.特別審批，促進(jìn)體外診斷試劑新技術(shù)的推廣與應(yīng)用，推動醫(yī)療器械產(chǎn)業(yè)的發(fā)展。ChapterIIEssentialRequirements第二章基本要求Article10Theregistrationapplicantandfillingentityofin-vitrodiagnosticreagentsshallestablishthequalitymanagementsystemrelatedtoproductresearch,developmentandmanufactureandshallkeepitseffectiveoperation.第十條體外診斷試劑注冊申請人和備案人應(yīng)當(dāng)建立與產(chǎn)品研制、生產(chǎn)有關(guān)的質(zhì)量管理體系，并保持有效運(yùn)行。Whereapplyingforregistrationofain-vitrodiagnosticreagentsubjecttothespecialreviewproceduresforinnovativemedicaldevicesanditssampleproductionisentrustedtoanotherenterprise,theapplicantshallentrustamedicaldevicemanufacturerhavingcorrespondingproductionrange.Wherethedomesticmedicaldeviceappliedforregistrationisnotsubjecttothespecialreviewproceduresforinnovativemedicaldevices,thesampleproductionshallnotbeentrustedtoanotherenterprise.按照創(chuàng)新醫(yī)療器械特別審批程序?qū)徟木硟?nèi)體外診斷試劑申請注冊時，樣品委托其他企業(yè)生產(chǎn)的，應(yīng)當(dāng)委托具有相應(yīng)生產(chǎn)范圍的醫(yī)療器械生產(chǎn)企業(yè)；不屬于按照創(chuàng)新醫(yī)療器械特別審批程序?qū)徟木硟?nèi)體外診斷試劑申請注冊時，樣品不得委托其他企業(yè)生產(chǎn)。Article11Thepersonsundertakingregistrationorfilingforin-vitrodiagnosticreagentsshallhavecorrespondingspecializedknowledgeandbefamiliarwiththelaws,rules,regulationsandtechnicalrequirementsoftheadministrationonregistrationorfilingofin-vitrodiagnosticreagent.第十一條辦理體外診斷試劑注冊或者備案事務(wù)的人員應(yīng)當(dāng)具有相應(yīng)的專業(yè)知識，熟悉醫(yī)療器械注冊或者備案管理的法律、法規(guī)、規(guī)章和技術(shù)要求。Article12Theresearchanddevelopmentofin-vitrodiagnosticreagentsinvolvesmainrawmaterialsselectionandpreparation,manufacturingprocess第十二條體外診斷試劑產(chǎn)品研制包括：主要原材料的選擇、制備，產(chǎn)品生產(chǎn)工藝的確定，產(chǎn)品技術(shù)要求的擬訂，產(chǎn)品穩(wěn)定性研究，陽性判斷值或者參

determination,producttechnicalrequirementsdrafting,productstabilitystudy,positivejudgmentvalueorreferencerangedetermination,productanalysisperformanceevaluationandclinicalevaluation,etc..考區(qū)間確定，產(chǎn)品分析性能評估，臨床評價等相關(guān)工作。Theapplicantorfilingentitymayconductproductresearchanddevelopmentwithreferencetotherelevanttechnicalguidelines,andmayalsoadoptdifferenttestmethodsortechnicalmeanswhileitisrequiredtodescribetheirreasonableness.申請人或者備案人可以參考相關(guān)技術(shù)指導(dǎo)原則進(jìn)行產(chǎn)品研制，也可以采用不同的實(shí)驗(yàn)方法或者技術(shù)手段，但應(yīng)當(dāng)說明其合理性。Article13Whenapplyingforregistrationorfiling,theapplicantorfilingentityshallcompletetheresearchanddevelopmentofin-vitrodiagnosticreagentsinaccordancewiththeessentialrequirementsforsafetyandeffectivenessofin-vitrodiagnosticreagentsandmakesuretheresearchanddevelopmentprocessistrueandstandardizedandallthedataisauthentic,completeandtraceable.第十三條申請人或者備案人申請注冊或者辦理備案，應(yīng)當(dāng)遵循體外診斷試劑安全有效的各項(xiàng)要求，保證研制過程規(guī)范，所有數(shù)據(jù)真實(shí)、完整和可溯源。Article14ThedocumentsforregistrationapplicationorfilingshallbeinChinese,wheretheyaretranslatedfromaforeignlanguage,theoriginaldocumentsshallalsobeprovidedatthesametime.Whenreferringtounpublishedliterature,theapplicantshallprovidedocumentsprovingoftheowner,spermissiontousetheinformation.第十四條申請注冊或者辦理備案的資料應(yīng)當(dāng)使用中文。根據(jù)外文資料翻譯的，應(yīng)當(dāng)同時提供原文。引用未公開發(fā)表的文獻(xiàn)資料時，應(yīng)當(dāng)提供資料所有者許可使用的證明文件。Theapplicantandfilingentityshalltakefullresponsibilityfortheauthenticityofthedocumentssubmitted.申請人、備案人對資料的真實(shí)性負(fù)責(zé)。Article15Animportin-vitrodiagnosticreagentsbeingappliedforregistrationshallbeonewhichhasalreadygot第十五條申請注冊或者辦理備案的進(jìn)口體外診斷試劑，應(yīng)當(dāng)在申請人或者備案人注冊地或者生產(chǎn)地址所在國

permissionfordistributioninthecountry(region)wheretheapplicantorfilingentityisregisteredorthemanufactureiscarriedout.家（地區(qū)）已獲準(zhǔn)上市銷售。Iftheproductisnotmanagedasmedicaldeviceinthecountry(region)wheretheapplicantorfilingentityisregisteredorthemanufactureiscarriedout,theapplicantorfilingentityshallproviderelevantproofdocuments,includingthepermissionfordistributionofsoldproductinthecountry(region)wheretheapplicantorfilingentityisregisteredorthemanufactureiscarriedout.申請人或者備案人注冊地或者生產(chǎn)地址所在國家（地區(qū)）未將該產(chǎn)品作為醫(yī)療器械管理的，申請人或者備案人需提供相關(guān)證明文件，包括注冊地或者生產(chǎn)地址所在國家（地區(qū)）準(zhǔn)許該產(chǎn)品上市銷售的證明文件。Article16AnoverseasapplicantorfilingentityshallconductrelatedworkwiththesupportofitsrepresentativeofficeestablishedinChinaoranenterpriselegalpersoninChinadesignatedbyitasitsagent.第十六條境外申請人或者備案人應(yīng)當(dāng)通過其在中國境內(nèi)設(shè)立的代表機(jī)構(gòu)或者指定中國境內(nèi)的企業(yè)法人作為代理人，配合境外申請人或者備案人開展相關(guān)工作。Theagentshallundertakethefollowingliabilitiesinadditiontoconductingin-vitrodiagnosticreagentsregistrationorfiling:代理人除辦理體外診斷試劑注冊或者備案事宜外，還應(yīng)當(dāng)承擔(dān)以下責(zé)任：(I)Contactingwithcorrespondingfoodanddrugregulatorydepartmentandoverseasapplicantorfilingentity.（一）與相應(yīng)食品藥品監(jiān)督管理部門、境外申請人或者備案人的聯(lián)絡(luò)；(II)Deliveringrelatedlawsandregulationsandtechnicalrequirementstotheapplicantoffilingentityinatruthfulandfaithfulmanner.（二）向申請人或者備案人如實(shí)、準(zhǔn)確傳達(dá)相關(guān)的法規(guī)和技術(shù)要求；(III)Collectingpost-marketadverseeventinformationofin-vitrodiagnosticreagentsandsendingfeedbacktooverseasregistrantsorfilingentity,meanwhile,reportingtorelevantfoodanddrugregulatorydepartment.（三）收集上市后體外診斷試劑不良事件信息并反饋境外注冊人或者備案人，同時向相應(yīng)的食品藥品監(jiān)督管理部門報告；

(IV)Coordinatingthein-vitrodiagnosticreagentspost-marketproductrecallandreportingtorelevantfoodanddrugregulatorydepartment.（四）協(xié)調(diào)體外診斷試劑上市后的產(chǎn)品召回工作，并向相應(yīng)的食品藥品監(jiān)督管理部門報告；(V)Otherjointliabilitiesrelatedtoproductqualityandafter-salesservice.（五）其他涉及產(chǎn)品質(zhì)量和售后服務(wù)的連帶責(zé)任。ChapterIIIProductClassificationandNaming第三章產(chǎn)品的分類與命名Article17Accordingtoproductriskdegreeintheorderoflowertohigher,in-vitrodiagnosticreagentsshallbeclassifiedintoclassI,classIIandclassIIIproducts.第十七條根據(jù)產(chǎn)品風(fēng)險程度由低到高，體外診斷試劑分為第一類、第二類、第三類產(chǎn)品。ClassIproductsMicroorganismculturemedium(notapplicabletomicroorganismidentificationanddrugsensitivitytesting).Productsforspecimentreatment,e.g.hemolyticagents,diluents,stainingsolutions,etc.（一）第一類產(chǎn)品L微生物培養(yǎng)基（不用于微生物鑒別和藥敏試驗(yàn)）；2.樣本處理用產(chǎn)品，如溶血劑、稀釋液、染色液等。ClassIIproductsProductsnotclearlydefinedasclassIandclassIIIproductsareclassIIproducts,mainlyincluding:Reagentsusedforproteintesting.Reagentsusedforcarbohydratetesting.Reagentsusedforhormonetesting.Reagentsusedforenzymestesting.Reagentsusedforesterstesting.Reagentsusedforvitamintesting.Reagentsusedforinorganiciontesting.Reagentsusedforthetestingofdrugsanddrugmetabolites.Reagentsusedforauto-antibodytesting.Reagentsusedformicroorganism（二）第二類產(chǎn)品除已明確為第一類、第三類的產(chǎn)品，其他為第二類產(chǎn)品，主要包括：.用于蛋白質(zhì)檢測的試劑；.用于糖類檢測的試劑；.用于激素檢測的試劑；.用于酶類檢測的試劑；.用于酯類檢測的試劑；.用于維生素檢測的試劑；.用于無機(jī)離子檢測的試劑；.用于藥物及藥物代謝物檢測的試劑；.用于自身抗體檢測的試劑；.用于微生物鑒別或者藥敏試驗(yàn)的試劑；.用于其他生理、生化或者免疫功能指標(biāo)檢測的試劑。

identificationandmedicinesensitivityexperiment.11.Reagentsusedforindicesinspectionsuchasphysiologicalindices,biochemicalindicesandimmunefunctionsindices.ClassIIIproductsReagentsrelatedtothetestingofantigen,antibodyandnucleicacid,etc.forpathogen.Reagentsrelatedtobloodgroupingandtissuetyping.Reagentsrelatedtohumangenetictesting.Reagentsrelatedtoinheriteddiseases.Reagentsrelatedtothetestingofnarcoticdrugs,psychotropicdrugsandtoxicdrugsformedicaluse.Reagentsrelatedtothetestingoftargetsofcurativedrugs.Reagentsrelatedtothetestingoftumormarkers.Reagentsrelatedtoallergy(allergen).（三）第三類產(chǎn)品.與致病性病原體抗原、抗體以及核酸等檢測相關(guān)的試劑；.與血型、組織配型相關(guān)的試劑；.與人類基因檢測相關(guān)的試劑；.與遺傳性疾病相關(guān)的試劑；.與麻醉藥品、精神藥品、醫(yī)療用毒性藥品檢測相關(guān)的試劑；.與治療藥物作用靶點(diǎn)檢測相關(guān)的試劑；.與腫瘤標(biāo)志物檢測相關(guān)的試劑；.與變態(tài)反應(yīng)（過敏原）相關(guān)的試劑。Article18IfaclassIIproductlistedinArticle17isusedformonitoringofdiagnosis,auxiliarydiagnosisandtreatmentprocessoftumors,orfordiagnosisandauxiliarydiagnosis,etc.ofinheriteddiseases,itshallberegisteredandmanagedasaclassIIIproduct.Forreagentsusedforinspectionofdrugsanddrugmetabolites,ifthedrugsbelongtothescopeofnarcoticdrugs,psychotropicdrugsandtoxicdrugsformedicaluse,theyshallberegisteredandmanagedasclassIIIproducts.第十八條第十七條所列的第二類產(chǎn)品如用于腫瘤的診斷、輔助診斷、治療過程的監(jiān)測U，或者用于遺傳性疾病的診斷、輔助診斷等，按第三類產(chǎn)品注冊管理。用于藥物及藥物代謝物檢測的試劑，如該藥物屬于麻醉藥品、精神藥品或者醫(yī)療購性藥品范圍的，按第三類產(chǎn)品注冊管理。Article19Forthecalibratorsandqualitycontrolsusedinconjunctionwithin-vitrodiagnosticreagents,theapplicantmaysubmitanapplicationforregistrationofsuchcalibratorsandcontrolmaterialstogetherwiththein-vitrodiagnostic第十九條校準(zhǔn)品、質(zhì)控品可以與配合使用的體外診斷試劑合并申請注冊，也可以單獨(dú)申請注冊。

reagentorsubmitseparateapplicationforregistration.ThecalibratorsandcontrolmaterialsusedinconjunctionwithclassIin-vitrodiagnosticreagentsareregisteredasclassIIproducts.WhenseparateapplicationsaresubmittedforregistrationofsomecalibratorsandcontrolmaterialsusedinconjunctionwithclassIIandIIIin-vitrodiagnosticreagents,suchcalibratorsandcontrolmaterialsshallberegisteredaccordingtothesameclassasthatofthereagents.Calibratorsorcontrolmaterialsformultipleanalyses,registrationwillbemadeaccordingtothehighestclass.與第一類體外診斷試劑配合使用的校準(zhǔn)品、質(zhì)控品，按第二類產(chǎn)品進(jìn)行注冊；與第二類、第三類體外診斷試劑配合使用的校準(zhǔn)品、質(zhì)控品單獨(dú)申請注冊時，按與試劑相同的類別進(jìn)行注冊；多項(xiàng)校準(zhǔn)品、質(zhì)控品，按其中的高類別進(jìn)行注冊。Article20ChinaFoodandDrugAdministrationshallberesponsibleforcompilingandadjustingtheclassificationcatalogueofin-vitrodiagnosticreagents.第二十條國家食品藥品監(jiān)督管理總局負(fù)責(zé)體外診斷試劑產(chǎn)品分類目錄的制定和調(diào)整。Foranewlydevelopedin-vitrodiagnosticreagentnotyetlistedintheclassificationcatalogue,theapplicantmaydirectlyapplyforaclassIIIin-vitrodiagnosticreagentregistration,or,afterdeterminingtheclassoftheproductinaccordancewiththeclassificationrulesandapplyingforclassconfirmationtotheChinaFoodandDrugAdministration,applyforregistrationorforfiling.對新研制的尚未列入體外診斷試劑分類目錄的體外診斷試劑，申請人可以直接申請第三類體外診斷試劑產(chǎn)品注冊，也可以依據(jù)分類規(guī)則判斷產(chǎn)品類別向國家食品藥品監(jiān)督管理總局申請類別確認(rèn)后，申請產(chǎn)品注冊或者辦理產(chǎn)品備案。WhereaclassIIIin-vitrodiagnosticreagentregistrationisdirectlyappliedfor,ChinaFoodandDrugAdministrationshalldeterminetheclassbasedonitsriskdegree.Whereadomesticin-vitrodiagnosticreagentisdeterminedasclassII,ChinaFoodandDrugAdministrationshallforwardtheapplicationmaterialstothefoodanddrugregulatorydepartmentoftheprovince,autonomousregion,ormunicipalitydirectlyunderthecentralgovernmentwheretheapplicantis直接申請第三類體外診斷試劑注冊的，國家食品藥品監(jiān)督管理總局按照風(fēng)險程度確定類別。境內(nèi)體外診斷試劑確定為第二類的，國家食品藥品監(jiān)督管理總局將申報資料轉(zhuǎn)申請人所在地省、自治區(qū)、直轄市食品藥品監(jiān)督管理部門審評審批；境內(nèi)體外診斷試劑確定為第一類的，國家食品藥品監(jiān)督管理總局將申報資料轉(zhuǎn)申請人所在地設(shè)區(qū)的市級食品藥品監(jiān)督管理部門備案。

locatedforevaluationandapproval.Whereadomesticin-vitrodiagnosticreagentisdeterminedasclassI,ChinaFoodandDrugAdministrationshallforwardtheapplicationmaterialstothefoodanddrugregulatorydepartmentofthecityconsistingofdistrictswheretheapplicantislocated.Article21Namingforin-vitrodiagnosticreagentsshallcomplywiththefollowingprinciples:第二十一條體外診斷試劑的命名應(yīng)當(dāng)遵循以下原則：Productnamesofin-vitrodiagnosticreagentsaregenerallycomposedofthreeparts.Thefirstpartshallbethenameofthesubstancetested.Thesecondpartshallbetheusage,e.g.diagnosisserum,diagnosticregentkit,controlmaterials,etc..Thethirdpartshallbethemethodormechanism,e.g.enzyme-linkedimmunosorbentassay,colloidalgoldassay,etc.,andthispartshallbelistedinparentheses.體外診斷試劑的產(chǎn)品名稱一般可以由三部分組成。第一部分：被測物質(zhì)的名稱；第二部分：用途，如診斷血清、測定試劑盒、質(zhì)控品等；第三部分：方法或者原理，如酶聯(lián)免疫吸附法、膠體金法等，本部分應(yīng)當(dāng)在括號中列出。Ifthesubstancetobetestedhasmanycomponentsorisunderspecialcircumstances,thesubstancecanadopttheindicationnamerelatedtotheproductorothersubstitutenames.ClassIproducts,calibratorsandcontrolmaterialsshallbenamedaccordingtotheirintendeduse.如果被測物組分較多或者有其他特殊情況，可以采用與產(chǎn)品相關(guān)的適應(yīng)癥名稱或者其他替代名稱。第一類產(chǎn)品和校準(zhǔn)品、質(zhì)控品，依據(jù)其預(yù)期用途進(jìn)行命名。ChapterIVTechnicalRequirementsandRegistrationTesting第四章產(chǎn)品技術(shù)要求和注冊檢驗(yàn)Article22Theapplicantorthefillingentityshall,underthepreconditionsofstablerawmaterialqualityandmanufacturingprocess,draftthetechnicalrequirementsoftheproductbasingontheresultsofproductdevelopmentandclinicalevaluation,etc.,andinaccordancewithnational第二十二條申請人或者備案人應(yīng)當(dāng)在原材料質(zhì)量和生產(chǎn)工藝穩(wěn)定的前提下，根據(jù)產(chǎn)品研制、臨床評價等結(jié)果，依據(jù)國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)及有關(guān)文獻(xiàn)資料，擬訂產(chǎn)品技術(shù)要求。

standards,industrystandardsandrelatedliterature.Producttechnicalrequirementsmainlyincludetheperformanceindicatorsandtestingmethodofthefinishedin-vitrodiagnosticreagents.Performanceindicatorsrefertofunctionalandsafetyindicatorsandotherqualitycontrolindicatorsoffinishedin-vitrodiagnosticreagentsthatcanbemeasuredobjectively.產(chǎn)品技術(shù)要求主要包括體外診斷試劑成品的性能指標(biāo)和檢驗(yàn)方法，其中性能指標(biāo)是指可進(jìn)行客觀判定的成品的功能性、安全性指標(biāo)以及與質(zhì)量控制相關(guān)的其他指標(biāo)。InthetechnicalrequirementsforclassIIIin-vitrodiagnosticreagents,itisrequiredtomakecleartherequirementsformainrawmaterials,manufacturingprocessandin-processproductsintheformofannex.第三類體外診斷試劑的產(chǎn)品技術(shù)要求中應(yīng)當(dāng)以附錄形式明確主要原材料、生產(chǎn)工藝及半成品要求。TheproducttechnicalrequirementsforclassIin-vitrodiagnosticreagentsshallbesubmittedtothefoodanddrugregulatorydepartmentatthetimeoffilingbyfilingentity.TheproducttechnicalrequirementsforclassIIandclassIIIin-vitrodiagnosticreagentsshallbeapprovedbythefoodanddrugregulatorydepartmentatthetimeofregistrationapproval.第一類體外診斷試劑的產(chǎn)品技術(shù)要求由備案人辦理備案時提交食品藥品監(jiān)督管理部門。第二類、第三類體外診斷試劑的產(chǎn)品技術(shù)要求由食品藥品監(jiān)督管理部門在批準(zhǔn)注冊時予以核準(zhǔn)。Thein-vitrodiagnosticreagentsmarketedinChinashallcomplywiththeproducttechnicalrequirementswhichareapprovedbyregistrationorfiled.在中國上市的體外診斷試劑應(yīng)當(dāng)符合經(jīng)注冊核準(zhǔn)或者備案的產(chǎn)品技術(shù)要求。Article23WhenapplyingforclassIIandclassIIIin-vitrodiagnosticreagentregistration,registrationtestingshallbeconducted,andclassIIIproductsshallconductregistrationtestingonsamplesinthreecontinuousmanufacturebatches.Themedicaldevicetestinginstitutionsshallcarryoutrelevantregistrationtestingontheproductsinaccordance第二十三條申請第二類、第三類體外診斷試劑注冊，應(yīng)當(dāng)進(jìn)行注冊檢驗(yàn)；第三類產(chǎn)品應(yīng)當(dāng)進(jìn)行連續(xù)3個生產(chǎn)批次樣品的注冊檢驗(yàn)。醫(yī)療器械檢驗(yàn)機(jī)構(gòu)應(yīng)當(dāng)依據(jù)產(chǎn)品技術(shù)要求對相關(guān)產(chǎn)品進(jìn)行檢驗(yàn)。

withtheproducttechnicalrequirements.Theproductionofsamplesforregistrationtestingshallcomplywithrelevantrequirementsofqualitymanagementsystemformedicaldevices.Clinicaltrialsorregistrationapplicationcanbecarriedoutonlyaftertheproductspassedtheregistrationtesting.注冊檢驗(yàn)樣品的生產(chǎn)應(yīng)當(dāng)符合醫(yī)療器械質(zhì)量管理體系的相關(guān)要求，注冊檢驗(yàn)合格的方可進(jìn)行臨床試驗(yàn)或者申請注冊。ForthefilingofclassIin-vitrodiagnosticreagent,thefilingentitymaysubmittheproductself-testingreport.辦理第一類體外診斷試劑備案的，備案人可以提交產(chǎn)品自檢報告。Article24Fortheapplicationofregistrationtesting,theapplicantshallsubmitrelevanttechnicaldocumentsandsamplesforregistrationtesting,producttechnicalrequirementsandstandardproductsorreferencematerialsasrequiredaccordingtotheregistrationtestingtothetestinginstitutions.第二十四條申請注冊檢驗(yàn)，申請人應(yīng)當(dāng)向檢驗(yàn)機(jī)構(gòu)提供注冊檢驗(yàn)所需要的有關(guān)技術(shù)資料、注冊檢驗(yàn)用樣品、產(chǎn)品技術(shù)要求及標(biāo)準(zhǔn)品或者參考品。Foradomesticapplicant,thesamplesforregistrationtestingshallbedrawnoutbythefoodanddrugregulatorydepartment.境內(nèi)申請人的注冊檢驗(yàn)用樣品由食品藥品監(jiān)督管理部門抽取。Article25Fortheproductswithnationalstandardproductsandreferenceproducts,itisrequiredtousenationalstandardproductsandreferencematerialsforregistrationtesting.NationalInstitutesforFoodandDrugControlisresponsiblefororganizingthepreparationandcalibrationofnationalstandardproductsandreferencematerials.第二十五條有國家標(biāo)準(zhǔn)品、參考品的產(chǎn)品應(yīng)當(dāng)使用國家標(biāo)準(zhǔn)品、參考品進(jìn)行注冊檢驗(yàn)。中國食品藥品檢定研究院負(fù)責(zé)組織國家標(biāo)準(zhǔn)品、參考品的制備和標(biāo)定工作。Article26Medicaldevicetestinginstitutionsshallhavetherelevantqualificationofmedicaldevicetesting,andperformtestingwithintheirspecifiedtestingscope.Itshallcarryoutpreevaluationoftheproducttechnicalrequirements.Thepre-evaluation第二十六條醫(yī)療器械檢驗(yàn)機(jī)構(gòu)應(yīng)當(dāng)具有醫(yī)療器械檢驗(yàn)資質(zhì)、在其承檢范圍內(nèi)進(jìn)行檢驗(yàn)，并對申請人提交的產(chǎn)品技術(shù)要求進(jìn)行預(yù)評價。預(yù)評價意見隨注冊檢驗(yàn)報告一同出具給申請人。

opinionstogetherwiththemedicaldeviceregistrationtestingreportshallbesubmittedtotheapplicant.Forthemedicaldeviceshavingnotincludedinthetestingscopeofanymedicaldevicetestinginstitutions,thecorrespondingregistrationdepartmentshalldesignateatestinginstitutionwhichhasthecapabilitytoconductthetesting.尚未列入醫(yī)療器械檢驗(yàn)機(jī)構(gòu)承檢范圍的產(chǎn)品，由相應(yīng)的注冊審批部門指定有能力的檢驗(yàn)機(jī)構(gòu)進(jìn)行檢驗(yàn)。Article27Whereoneregistrationapplicationincludesdifferentpackagingsizes,itisallowedtoconductregistrationtestingontheproductofonepackagingsize.第二十七條同一注冊申請包括不同包裝規(guī)格時，可以只進(jìn)行一種包裝規(guī)格產(chǎn)品的注冊檢驗(yàn)。ChapterVClinicalEvaluation第五章臨床評價Article28Clinicalevaluationofin-vitrodiagnosticreagentsreferstotheprocessthattheapplicantorfilingentityvalidateswhethertheproductsunderregistrationcanmeettheirintendeduseandindicationsbasedontheinformationofclinicalliterature,clinicalexperiencedataandclinicaltrials.第二十八條體外診斷試劑臨床評價是指申請人或者備案人通過臨床文獻(xiàn)資料、臨床經(jīng)驗(yàn)數(shù)據(jù)、臨床試驗(yàn)等信息對產(chǎn)品是否滿足使用要求或者預(yù)期用途進(jìn)行確認(rèn)的過程。Article29Clinicalevaluationmaterialsrefertothedocumentsdevelopedthroughclinicalevaluationbytheapplicantorfilingentity.Theclinicaltrialofin-vitrodiagnosticreagents(includingthecomparativestudymadewiththemarketedproducts)referstothesystematicstudyontheclinicalperformanceofin-vitrodiagnosticreagentsinthecorrespondingclinicalenvironment.Fortheclinicaltrialofin-vitrodiagnosticreagentsarenotrequired,theapplicantshallevaluatetheclinicalperformanceofin-vitrodiagnosticreagentsthroughnon-clinicaltrialmethodssuchasevaluationontheclinicalsamplescoveringintendeduseandinterferencefactorsaswellascomprehensiveliteratures.Theapplicantorfilingentityshallensurethatthe第二十九條臨床評價資料是指申請人或者備案人進(jìn)行臨床評價所形成的文件。體外診斷試劑臨床試驗(yàn)（包括與已上市產(chǎn)品進(jìn)行的比較研究試驗(yàn)）是指在相應(yīng)的臨床環(huán)境中，對體外診斷試劑的臨床性能進(jìn)行的系統(tǒng)性研究。無需進(jìn)行臨床試驗(yàn)的體外診斷試劑，申請人或者備案人應(yīng)當(dāng)通過對涵蓋預(yù)期用途及干擾因素的臨床樣本的評估、綜合文獻(xiàn)資料等非臨床試驗(yàn)的方式對體外診斷試劑的臨床性能進(jìn)行評價。申請人或者備案人應(yīng)當(dāng)保證評價所用的臨床樣本具有可追溯性。

clinicalsamplesforevaluationaretraceable.Article30ForfilingofaclassIin-vitrodiagnosticreagent,clinicaltrialisnotrequired.ForapplicationforregistrationofaclassIIorclassIIIin-vitrodiagnosticreagent,clinicaltrialshallbeconducted;however,Inoneofthefollowingcircumstances,clinicaltrialmaybeexempted:第三十條辦理第一類體外診斷試劑備案，不需進(jìn)行臨床試驗(yàn)。申請第二類、第三類體外診斷試劑注冊，應(yīng)當(dāng)進(jìn)行臨床試驗(yàn)。有下列情形之一的，可以免于進(jìn)行臨床試驗(yàn)：(1)Wherethereactionprincipleisdefinite,thedesignisfinalized,theproductionprocessiswell-established,andthemarketedin-vitrodiagnosticreagentofthesamevarietyhasbeeninclinicaluseforyearsandnoseriousadverseeventsarerecorded,anditsconventionalpurposesofusearenotchanged,andtheapplicantcanprovidetheequivalenceevaluationdatatothemarketedproducts.（一）反應(yīng)原理明確、設(shè)計定型、生產(chǎn)工藝成熟，已上市的同品種體外診斷試劑臨床應(yīng)用多年且無嚴(yán)重不良事件記錄，不改變常規(guī)用途，申請人能夠提供與已上市產(chǎn)品等效性評價數(shù)據(jù)的；(2)Wherethesafetyandeffectivenessofanin-vitrodiagnosticreagentcanbeprovedthroughtheevaluationontheclinicalsamplescoveringintendeduseandinterferencefactors.Thecatalogueofin-vitrodiagnosticreagentthatisexemptedfromclinicaltrialshallbecompiled,adjustedandpublishedbyChinaFoodandDrugAdministration.（二）通過對涵蓋預(yù)期用途及干擾因素的臨床樣本的評價能夠證明該體外診斷試劑安全、有效的。免于進(jìn)行臨床試驗(yàn)的體外診斷試劑目錄由國家食品藥品監(jiān)督管理總局制定、調(diào)整并公布。Article31Whereoneregistrationapplicationincludesdifferentpackagingsizes,itisallowedtomakeclinicalevaluationonthesamplesofonepackagingsize.第三十一條同一注冊申請包括不同包裝規(guī)格時，可以只采用一種包裝規(guī)格的樣品進(jìn)行臨床評價。Article32TheapplicantofclassIIIproductsshallselectnolessthan3qualifiedclinicalinstitutions,theapplicantofclassIIproductsshallselectnolessthan2qualifiedclinical第三十二條第三類產(chǎn)品申請人應(yīng)當(dāng)選定不少于3家（含3家）、第二類產(chǎn)品申請人應(yīng)當(dāng)選定不少于2家（含2家）取得資質(zhì)的臨床試驗(yàn)機(jī)構(gòu)，按照有關(guān)規(guī)定開展臨床試驗(yàn)。臨床試驗(yàn)樣品的生產(chǎn)應(yīng)當(dāng)符合醫(yī)療器械

institutionstocarryoutclinicaltrialsaccordingtorelevantrequirements.Theproductionofthesamplesforclinicaltrialsshallcomplywiththerelevantrequirementsofthein-vitrodiagnosticreagentqualitymanagementsystem.質(zhì)量管理體系的相關(guān)要求。Article33Theapplicantshallconcludeandsignthecontractofclinicaltrialwiththeclinicaltrialinstitution,prepareandimprovetheclinicaltrialprotocolbyreferringtotherelatedtechnicalguidelines,providesamplesforclinicaltrialforfree,andassumethecostsofclinicaltrials.第三十三條申請人應(yīng)當(dāng)與臨床試驗(yàn)機(jī)構(gòu)簽訂臨床試驗(yàn)合同，參考相關(guān)技術(shù)指導(dǎo)原則制定并完善臨床試驗(yàn)方案，免費(fèi)提供臨床試驗(yàn)用樣品，并承擔(dān)臨床試驗(yàn)費(fèi)用。Article34Thenumberofclinicaltrialcasesshallbedeterminedaccordingtotheclinicaltrialobjective,requirementsofstatisticsandreferringtotherelatedtechnicalguidelines.Thetechnicalguidelinefortheclinicaltrialisissuedseparately.第三十四條臨床試驗(yàn)病例數(shù)應(yīng)當(dāng)根據(jù)臨床試驗(yàn)?zāi)康?、統(tǒng)計學(xué)要求，并參照相關(guān)技術(shù)指導(dǎo)原則確定。臨床試驗(yàn)技術(shù)指導(dǎo)原則另行發(fā)布。Foranin-vitrodiagnosticreagentwhichisusedtotreatararediseaseorisurgentlyneededindealingwithemergentpublichealthincidents,whichrequirescasesnumberreductionorclinicaltrialexempt,theapplicantshallapplyfortrialexemptandprovidedetailedreasonswhilesubmittingtheapplicationmaterials.Thetechnicalevaluationinstitutionoffoodanddrugregulatorydepartmentsshallperformcomprehensivetechnicalevaluationtotheregistrationapplicationmaterials,andinformtheapplicantbynoticeforsupplementsorcorrectionsinthecasethatclinicaltrialisrequired.用于罕見疾病以及應(yīng)對突發(fā)公共衛(wèi)生事件急需的體外診斷試劑，要求減少臨床試驗(yàn)病例數(shù)或者免做臨床試驗(yàn)的，申請人應(yīng)當(dāng)在提交注冊申報資料的同時，提出減免臨床試驗(yàn)的申請，并詳細(xì)說明理由。食品藥品監(jiān)督管理部門技術(shù)審評機(jī)構(gòu)對注冊申報資料進(jìn)行全面的技術(shù)審評后予以確定，需要補(bǔ)充臨床試驗(yàn)的，以補(bǔ)正資料的方式通知申請人。Article35Thedocumentsofoverseasclinicalevaluationshallbeprovidedfortheregistrationofimportin-vitrodiagnosticreagent.Theapplicantshallperformtargetedclinicalevaluation第三十五條申請進(jìn)口體外診斷試劑注冊，需要提供境外的臨床評價資料。申請人應(yīng)當(dāng)按照臨床評價的要求，同時考慮不同國家或者地區(qū)的流行病學(xué)背景、不同病種的特性、不同種屬人群所適用的陽性判斷值或者參

withintheterritoryofChinaaccordingtotherequirementsforclinicalevaluation,inconsiderationofepidemicsbackground,characteristicsofdifferentdiseases,positivejudgmentvalueorreferencerange,etc.suitableforpeopleofdifferentspeciesindifferentcountriesorregions.考區(qū)間等因素，在中國境內(nèi)進(jìn)行具有針對性的臨床評價。Article36Theclinicaltrialinstitutionshallrespectivelyprovidetheclinicaltrialreportaftercompletingtheclinicaltrial.Theapplicantorleadingunitofclinicaltrialshallsummarizetheresultsofclinicaltrialsandcompletethefinalreportaccordingtotherelevanttechnicalguidelines.第三十六條臨床試驗(yàn)機(jī)構(gòu)完成臨床試驗(yàn)后，應(yīng)當(dāng)分別出具臨床試驗(yàn)報告。申請人或者臨床試驗(yàn)牽頭單位根據(jù)相關(guān)技術(shù)指導(dǎo)原貝h對臨床試驗(yàn)結(jié)果進(jìn)行匯總，完成臨床試驗(yàn)總結(jié)報告。Article37Forthein-vitrodiagnosticreagentsusedbytheconsumerhimself,theevaluationoncognitivecompetenceofinstructionsbytheconsumerwithoutmedicalsciencebackgroundshallbeincludedduringclinicaltrial.第三十七條由消費(fèi)者個人自行使用的體外診斷試劑，在臨床試驗(yàn)時，應(yīng)當(dāng)包含無醫(yī)學(xué)背景的消費(fèi)者對產(chǎn)品說明書認(rèn)知能力的評價。Article38Wheretheapplicantfindsththeclinicaltrialinstitutionviolatesrelevantregulationsorfailstoperformstheclinicaltrialprotocol,itshallsuperviseandurgetheclinicaltrialinstitutiontocorrect;Incaseofsevereconditions,theapplicantcanrequiresuspendingorterminatingtheclinicaltrial,andreporttothefoodanddrugregulatorydepartmentoftheprovinces,autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernmentwheretheclinicaltrialinstitutionislocatedandChinaFoodandDrugAdministration.a第三十八條申請人發(fā)現(xiàn)臨床試驗(yàn)機(jī)構(gòu)違反有關(guān)規(guī)定或者未執(zhí)行臨床試驗(yàn)方案的，應(yīng)當(dāng)督促其改正；情節(jié)嚴(yán)重的，可以要求暫?；蛘呓K止臨床試驗(yàn)，并向臨床試驗(yàn)機(jī)構(gòu)所在地省、自治區(qū)、直轄市食品藥品監(jiān)督管理部門和國家食品藥品監(jiān)督管理總局報告。Article39Wheretheapplicantviolatesrelevantregulationsorrequireschangeoftrialdataandconclusion,theparticipatinginstitutionanditspersonnelshallreporttothefoodanddrugregulatorydepartmentoftheprovinces,第三十九條參加臨床試驗(yàn)的機(jī)構(gòu)及人員，對申請人違反有關(guān)規(guī)定或者要求改變試驗(yàn)數(shù)據(jù)、結(jié)論的，應(yīng)當(dāng)向申請人所在地省、自治區(qū)、直轄市食品藥品監(jiān)督管理部門和國家食品藥品監(jiān)督管理總局報告。

autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernmentwheretheapplicantislocatedandChinaFoodandDrugAdministration.Article40Theclinicaltrialofin-vitrodiagnosticreagentsshallbefiledwiththefoodanddrugregulatorydepartmentoftheprovinces,autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernmentwheretheapplicantislocated.Thefoodanddrugregulatorydepartmentacceptingthefillingshallreporttothefoodanddrugregulatorydepartmentandthecompetenthealthandfamilyplanningdepartmentatthesamelevelwheretheclinicaltrialinstitutionislocated.第四十條開展體外診斷試劑臨床試驗(yàn)，應(yīng)當(dāng)向申請人所在地省、自治區(qū)、直轄市食品藥品監(jiān)督管理部門備案。接受備案的食品藥品監(jiān)督管理部門應(yīng)當(dāng)將備案情況通報臨床試驗(yàn)機(jī)構(gòu)所在地的同級食品藥品監(jiān)督管理部門和衛(wèi)生計生主管部門。ChinaFoodandDrugAdministrationandthefoodanddrugregulatorydepartmentoftheprovinces,autonomousregionsandmunicipalitiesdirectlyunderthecentralgovernmentshallsuperviseandinspecttheimplementationsituationofclinicaltrialaccordingtonecessity.國家食品藥品監(jiān)督管理總局和省、自治區(qū)、直轄市食品藥品監(jiān)督管理部門根據(jù)需要對臨床試驗(yàn)的實(shí)施情況進(jìn)行監(jiān)督檢查。ChapterVIProductRegistration第六章產(chǎn)品注冊Article41Toapplyforin-vitrodiagnosticreagentregistration,theapplicantshallsubmitapplicationmaterialstothefoodanddrugregulatorydepartmentinaccordancewithrelevantrequirements.第四十一條申請體外診斷試劑注冊，申請人應(yīng)當(dāng)按照相關(guān)要求向食品藥品監(jiān)督管理部門報送申報資料。Article42Thefoodanddrugregulatorydepartmentshallconductformalreviewafteracceptinganapplication,andhandlerespectivelyaccordingtothefollowingcircumstances:第四十二條食品藥品監(jiān)督管理部門收到申請后對申報資料進(jìn)行形式審查，并根據(jù)下列情況分別作出處理：(I)Wheretheapplicationiswithinfunctionsanddutiesofdepartment,andtheapplicationmaterialsarecompleteandmeetthepreliminaryreview（一）申請事項(xiàng)屬于本部門職權(quán)范圍，申報資料齊全、符合形式審查要求的，予以受理；

requirements.(II)Wheretheapplicationmaterialshaveerrorsthatm