醫(yī)療器械注冊管理辦法(中英文)翻譯

1、醫(yī)療器械注冊管理辦法MedicalDevicesRegistrationAdministrationMethod總則Chapter1GeneralProvisions第一條為規(guī)范醫(yī)療器械的注冊管理，保證醫(yī)療器械的安全、有效，根據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》，制定本辦法。Article1Toregulatemedicaldeviceregistrationmanagementensuretheirsafetyeffectivenessofme

2、dicaldevicewesetdownthemanagementmeasureaccdingtoRegulationsftheSupervisionAdministrationofMedicalDevice.第二條在中華人民共和國境內(nèi)銷售、使用的醫(yī)療器械均應(yīng)當(dāng)按照本辦法的規(guī)定申請注冊，未獲準(zhǔn)注冊的醫(yī)療器械，不得銷售、使用。Article2Allthemedicaldevicewhichwouldliketosellusewithint

3、heterrityofthePeople’sRepublicofChinashallapplyfregistrationcomplyingwiththismeasure.ThesemedicaldeviceswhichnotgetChinaregistrationapprovalshouldbeprohibitedtoselluse.第三條醫(yī)療器械注冊，是指依照法定程序，對擬上市銷售、使用的醫(yī)療器械的安全性、有效性進(jìn)行系統(tǒng)評價(jià)，以決定是

4、否同意其銷售、使用的過程。Article3Medicaldeviceregistrationistheprocessofdoingsystemicevaluationofplanmarketmedicaldeviceontheirsafetyeffectivenessthendecideifmedicaldevicecanbeallowedtoselluse.第四條國家對醫(yī)療器械實(shí)行分類注冊管理。Article4Thestateshal

5、lclassifymedicaldevicesadministerthembasedonthisclassification.境內(nèi)第一類醫(yī)療器械由設(shè)區(qū)的市級（食品）藥品監(jiān)督管理機(jī)構(gòu)審查，批準(zhǔn)后發(fā)給醫(yī)療器械注冊證書。DomesticClassImedicaldevicesshallbeinspectedapprovedgrantedwitharegistrationcertificatebythefooddrugregulatyauthi

6、tyofthegovernmentofthemunicipalitiesconsistingofdistricts.境內(nèi)第二類醫(yī)療器械由省、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)療器械注冊證書。DomesticClassIImedicaldevicesshallbeinspectedapprovedgrantedwitharegistrationcertificatebythefooddrugregulatyauthi

7、tiesofprovincesautonomousregionsmunicipalitiesdirectlyunderthecentralgovernment.境內(nèi)第三類醫(yī)療器械由國家食品藥品監(jiān)督管理局審查，批準(zhǔn)后發(fā)給醫(yī)療器械注冊證書。DomesticClassIIImedicaldeviceshallbeinspectedapprovedgrantedwithregistrationcertificatebyStateFoodDrug

8、Administration.醫(yī)療器械注冊證書附有《醫(yī)療器械注冊登記表》（見本辦法附件1），與醫(yī)療器械注冊證書同時(shí)使用。Medicaldeviceregistrationcertificateisattachedwithmedicaldeviceregistrationrecdshallbeusedalongwithmedicaldeviceregistrationcertificate.第六條生產(chǎn)企業(yè)提出醫(yī)療器械注冊申請，承擔(dān)相應(yīng)的法

9、律義務(wù)，并在該申請獲得批準(zhǔn)后持有醫(yī)療器械注冊證書。Manufacturersputfwardmedicaldeviceregistrationapplicationtakerelevantregalresponsibilitykeepmedicaldeviceregistrationcertificateaftergettingapplicationapproval.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，并具有相應(yīng)的專業(yè)知識(shí)

10、，熟悉醫(yī)療器械注冊管理的法律、法規(guī)、規(guī)章和技術(shù)要求。Individualswhodomedicaldeviceregistrationapplicationshouldbeauthizedbymanufacturerpossessprofessionalknowledgearefamiliarwithmedicaldeviceregistrationadministrationlawregulationrulestechnicalreq

11、uirement.申請境外醫(yī)療器械注冊的，境外生產(chǎn)企業(yè)應(yīng)當(dāng)在中國境內(nèi)指定機(jī)構(gòu)作為其代理人，代理人應(yīng)當(dāng)承擔(dān)相應(yīng)的法律責(zé)任；并且，境外生產(chǎn)企業(yè)應(yīng)當(dāng)委托中國境內(nèi)具有相應(yīng)資格的法人機(jī)構(gòu)或者委托其在華機(jī)構(gòu)承擔(dān)醫(yī)療器械售后服務(wù)。WhendoingimptedmedicaldevicesregistrationtheoverseasmanufacturesshallauthizeanunittobetheiragentinChineseterrity

12、theagentshouldtakerelevantlegalresponsibilities.MeanwhileoverseasmanufacturesshallauthizequalifiedbodycpatetheirsownganlocatedinChinatodoaftersalesservice.第七條申請注冊的醫(yī)療器械，應(yīng)當(dāng)有適用的產(chǎn)品標(biāo)準(zhǔn)，可以采用國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)或者制定注冊產(chǎn)品標(biāo)準(zhǔn)，但是注冊產(chǎn)品標(biāo)準(zhǔn)不得低于國家標(biāo)準(zhǔn)或

13、者行業(yè)標(biāo)準(zhǔn)。Article7Medicaldeviceswhichapplyingfregistrationshallhavesuitableproductstardthatcanadoptstatestardindustrystardeditregistrationstardbutregistrationstardshouldnotinferitostatestardindustrystard.注冊產(chǎn)品標(biāo)準(zhǔn)應(yīng)當(dāng)依據(jù)國家食品藥品監(jiān)督管理

14、局規(guī)定的醫(yī)療器械標(biāo)準(zhǔn)管理要求編制。Registrationstardshallbeeditedaccdingtomedicaldevicestardadministrationregulationstipulatedbystatefooddrugsupervisionadministration.第八條申請第二類、第三類醫(yī)療器械注冊，生產(chǎn)企業(yè)應(yīng)當(dāng)符合國家食品藥品監(jiān)督管理局規(guī)定的生產(chǎn)條件或者相關(guān)質(zhì)量體系要求。Article8Applyin

15、gfClassIIClassIIImedicaldeviceregistrationmanufactureshallcomplywithrelevantmanufacturingconditionqualitysystemrequirementstipulatedbystatefooddrugsupervisionadministration.第二章醫(yī)療器械注冊檢測Chapter2Medicaldevicesregistrationte