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《醫(yī)療器械監(jiān)督管理條例》，制定本辦法。Article1Toregulatemedicaldeviceregistrationmanagementensuretheirsafetyeffectivenessofme

2、dicaldevicewesetdownthemanagementmeasureaccdingtoRegulationsftheSupervisionAdministrationofMedicalDevice.第二條在中華人民共和國境內銷售、使用的醫(yī)療器械均應當按照本辦法的規(guī)定申請注冊，未獲準注冊的醫(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、有效性進行系統(tǒng)評價，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)療器械實行分類注冊管理。Article4Thestateshal

5、lclassifymedicaldevicesadministerthembasedonthisclassification.境內第一類醫(yī)療器械由設區(qū)的市級（食品）藥品監(jiān)督管理機構審查，批準后發(fā)給醫(yī)療器械注冊證書。DomesticClassImedicaldevicesshallbeinspectedapprovedgrantedwitharegistrationcertificatebythefooddrugregulatyauthi

6、tyofthegovernmentofthemunicipalitiesconsistingofdistricts.境內第二類醫(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，批準后發(fā)給醫(yī)療器械注冊證書。DomesticClassIImedicaldevicesshallbeinspectedapprovedgrantedwitharegistrationcertificatebythefooddrugregulatyauthi

7、tiesofprovincesautonomousregionsmunicipalitiesdirectlyunderthecentralgovernment.境內第三類醫(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使用。Medicaldeviceregistrationcertificateisattachedwithmedicaldeviceregistrationrecdshallbeusedalongwithmedicaldeviceregistrationcertificate.第六條生產企業(yè)提出醫(yī)療器械注冊申請，承擔相應的法

9、律義務，并在該申請獲得批準后持有醫(yī)療器械注冊證書。Manufacturersputfwardmedicaldeviceregistrationapplicationtakerelevantregalresponsibilitykeepmedicaldeviceregistrationcertificateaftergettingapplicationapproval.辦理醫(yī)療器械注冊申請事務的人員應當受生產企業(yè)委托，并具有相應的專業(yè)知識

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

11、uirement.申請境外醫(yī)療器械注冊的，境外生產企業(yè)應當在中國境內指定機構作為其代理人，代理人應當承擔相應的法律責任；并且，境外生產企業(yè)應當委托中國境內具有相應資格的法人機構或者委托其在華機構承擔醫(yī)療器械售后服務。WhendoingimptedmedicaldevicesregistrationtheoverseasmanufacturesshallauthizeanunittobetheiragentinChineseterrity

12、theagentshouldtakerelevantlegalresponsibilities.MeanwhileoverseasmanufacturesshallauthizequalifiedbodycpatetheirsownganlocatedinChinatodoaftersalesservice.第七條申請注冊的醫(yī)療器械，應當有適用的產品標準，可以采用國家標準、行業(yè)標準或者制定注冊產品標準，但是注冊產品標準不得低于國家標準或

13、者行業(yè)標準。Article7Medicaldeviceswhichapplyingfregistrationshallhavesuitableproductstardthatcanadoptstatestardindustrystardeditregistrationstardbutregistrationstardshouldnotinferitostatestardindustrystard.注冊產品標準應當依據國家食品藥品監(jiān)督管理

14、局規(guī)定的醫(yī)療器械標準管理要求編制。Registrationstardshallbeeditedaccdingtomedicaldevicestardadministrationregulationstipulatedbystatefooddrugsupervisionadministration.第八條申請第二類、第三類醫(yī)療器械注冊，生產企業(yè)應當符合國家食品藥品監(jiān)督管理局規(guī)定的生產條件或者相關質量體系要求。Article8Applyin

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