医疗器械注册管理办法英文版

DecreeofStateFoodandDrugAdministrationNo.16Aug.9,2004Page1/36TheMeasuresfortheAdministrationofMedicalDeviceRegistrationwerepassedbyStateFoodandDrugAdministrationattheadministrationaffairsmeetingonMay28,2004andareherebypromulgatedforimplementationasofthedateofpromulgation.Directorgeneral:ZhengXiaoyuAug.9,2004MeasuresfortheAdministrationofMedicalDeviceRegistrationChapter1.GeneralProvisionsArticle1TheseMeasuresareformulatedinaccordancewiththeRegulationsontheSupervisionandAdministrationofMedicalDevicestostandardizetheadministrationofmedicaldeviceregistrationandguaranteethesafetyandeffectivenessofmedicaldevices.Article2AllthemedicaldevicessoldandusedwithintheterritoryofthePeople’sRepublicofChinashallbesubjecttoapplicationforregistrationinaccordancewiththeprovisionsoftheseMeasures.Themedicaldeviceswhoseregistrationfailstobeapprovedshallnotbesoldorused.Article3Medicaldeviceregistrationmeanstheprocessofsystematicevaluationofthesafetyandeffectivenessofthemedicaldevicestobesoldandusedinaccordancewiththelegalprocedurestodecidewhetherthesaleanduseofsuchmedicaldevicescanbeapproved.Article4Chinaimplementsclassifiedregistrationandadministrationofmedicaldevices.CategoryIdomesticmedicaldevicesaresubjecttoexaminationbymunicipallevel(food)drugadministrationauthoritiesoftheadministrativeareaswithdistricts,andmedicaldeviceregistrationcertificateswillbeissuedafterapprovalbysuchauthorities.CategoryIIdomesticmedicaldevicesaresubjecttoexaminationbythe(food)drugadministrationauthoritiesofprovinces,autonomousregionsandmunicipalities,andmedicaldeviceregistrationcertificateswillbeissuedafterapprovalbysuchauthorities.CategoryIIIdomesticmedicaldevicesaresubjecttoexaminationbytheStateFoodandDrugAdministration(SFDA),andmedicaldeviceregistrationcertificateswillbeDecreeofStateFoodandDrugAdministrationNo.16Aug.9,2004Page2/36issuedafterapprovalbySFDA.ForeignmedicaldevicesaresubjecttoexaminationbySFDA,andmedicaldeviceregistrationcertificateswillbeissuedafterapprovalbySFDA.Unlessotherwisespecifiedhereunder,medicaldevicesfromTaiwan,HongKongandMacaoshallberegisteredbyreferencetothemeasuresfortheregistrationofforeignmedicaldevices.Thevalidperiodofeachmedicaldeviceregistrationcertificateshallbefouryears.Article5MedicaldeviceregistrationcertificatesshallbeprintedbySFDAinacentralizedway,whilethecorrespondingcontentsshallbecompletedbythe(food)drugadministrationauthoritiesresponsibleforexaminationandregistration.Registrationnumbersshallbearrangedinthefollowingform:×(×)1(S)YJX(×2)Z××××3No.×4××5××××6,where,×1shallmeantheabbreviationoftheplacewheretheregistrationexaminationandapprovalauthorityislocated:Theletter“G”shallbeadoptedforCategoryIIIdomesticmedicaldevices,foreignmedicaldevicesandmedicaldevicesfromTaiwan,HongKongandMacao;Theabbreviationoftheprovince,autonomousregionormunicipalitywheretheregistrationexaminationandapprovalauthorityislocatedshallbeadoptedforCategoryIImedicaldevices;Theabbreviationoftheprovince,autonomousregionormunicipalitywheretheregistrationexaminationandapprovalauthorityislocatedplustheabbreviationofthelocalmunicipalleveladministrativeareawithdistrictsshallbeadoptedintheformof××1forCategoryIdomesticmedicaldevices(onlytheabbreviationsofthelocalprovince,autonomousregionormunicipalityshallbeadoptedifthereisnocorrespondingmunicipalleveladministrativeareawithdistricts);×2shallindicatetheformofregistration(Z[approval],J[import]andX[permit]):“Z”isapplicabletodomesticmedicaldevices;“J”isapplicabletoforeignmedicaldevices;“X”isapplicabletomedicaldevicesfromTaiwan,HongKongandMacao;××××3shallindicatetheyearofapprovalforregistration;×4shallindicatethecategoryofproductadministration;××5shallindicatethetypecodeofproduct;and××××6shallindicatetheserialnumberofregistration.DecreeofStateFoodandDrugAdministrationNo.16Aug.9,2004Page3/36Themedicaldeviceregistrationrecord(seeAppendix1oftheseMeasures)attachedtoeachmedicaldeviceregistrationcertificateshallbeusedtogetherwiththemedicaldeviceregistrationcertificate.Article6Amanufacturerapplyingformedicaldeviceregistrationshallundertakethecorrespondinglegalobligationsandholdamedicaldeviceregistrationcertificateaftertheapplicationisapproved.Thepersonhandlingthemattersrelatedtoapplicationformedicaldeviceregistrationshallbesubjecttoauthorizationbythemanufacturer,havethecorrespondingprofessionalknowledgeandbefamiliarwiththelaws,rules,regulationsandtechnicalrequirementsontheadministrationofmedicaldeviceregistration.Regardingapplicationfortheregistrationofforeignmedicaldevices,theforeignmanufacturershalldesignateanorganizationlocatedwithintheterritoryofChinatoactastheforeignmanufacturer’sagent,whoshallundertakethecorrespondinglegalliability.TheforeignmanufacturershallalsoentrustacorporateorganizationthatislocatedwithintheterritoryofChinaandhasthecorrespondingqualificationsorentrustthemanufacturer’sorganinChinatoundertakeafter-saleserviceforthemedicaldevices.Article7Themedicaldeviceunderapplicationforregistrationshallhaveanapplicableproductstandard,whichmayadoptanationalstandard,aprofessionalstandardoraregisteredprod