醫(yī)療器械注冊管理辦法英文版

1、TheMeasuresfortheAdministrationofMedicalDeviceRegistrationwerepassedbyStateFoodandDrugAdministrationattheadministrationaffairsmeetingonMay28,2004andareherebypromulgatedforimplementationasofthedateofpromulgation.Directorgeneral:ZhengXiaoyuAug.9,2004MeasuresfortheAdministrationofMedicalDeviceRegistrat

2、ionChapter 1. GeneralProvisionsArticle 1TheseMeasuresareformulatedinaccordancewiththeRegulationsontheSupervisionandAdministrationofMedicalDevicestostandardizetheadministrationofmedicaldeviceregistrationandguaranteethesafetyandeffectivenessofmedicaldevices.Article 2Allthemedicaldevicessoldandusedwith

3、intheterritoryofthePeople'sRepulChinashallbesubjecttoapplicationforregistrationinaccordancewiththeprovisionsoftheseMeasures.Themedicaldeviceswhoseregistrationfailstobeapprovedshallnotbesoldorused.Article 3Medicaldeviceregistrationmeanstheprocessofsystematicevaluationofthesafetyandeffectivenessof

4、themedicaldevicestobesoldandusedinaccordancewiththelegalprocedurestodecidewhetherthesaleanduseofsuchmedicaldevicescanbeapproved.Article 4Chinaimplementsclassifiedregistrationandadministrationofmedicaldevices.CategoryIdomesticmedicaldevicesaresubjecttoexaminationbymunicipallevel(food)drugadministrati

5、onauthoritiesoftheadministrativeareaswithdistricts,andmedicaldeviceregistrationcertificateswillbeissuedafterapprovalbysuchauthorities.CategoryIIdomesticmedicaldevicesaresubjecttoexaminationbythe(food)drugadministrationauthoritiesofprovinces,autonomousregionsandmunicipalities,andmedicaldeviceregistra

6、tioncertificateswillbeissuedafterapprovalbysuchauthorities.CategoryIIIdomesticmedicaldevicesaresubjecttoexaminationbytheStateFoodandDrugAdministration(SFDA),andmedicaldeviceregistrationcertificateswillbeDecreeofStateFoodandDrugAdministrationNo.16Aug.9,2004issuedafterapprovalbySFDA.Foreignmedicaldevi

7、cesaresubjecttoexaminationbySFDA,andmedicaldeviceregistrationcertificateswillbeissuedafterapprovalbySFDA.Unlessotherwisespecifiedhereunder,medicaldevicesfromTaiwan,HongKongandMacaoshallberegisteredbyreferencetothemeasuresfortheregistrationofforeignmedicaldevices.Thevalidperiodofeachmedicaldeviceregi

8、strationcertificateshallbefouryears.Article 5MedicaldeviceregistrationcertificatesshallbeprintedbySFDAinacentralizedway,whilethecorrespondingcontentsshallbecompletedbythe(food)drugadministrationauthoritiesresponsibleforexaminationandregistration.Registrationnumbersshallbearrangedinthefollowingform:X

9、與1(S)YJX(2)Z>0<xMNo.4X>5XXX>6,where,Mshallmeantheabbreviationoftheplacewheretheregistrationexaminationandapprovalauthorityislocated:Theletter"G,shallbeadoptedforCategoryIIIdomesticmedicaldevices,foreignmedicaldevicesandmedicaldevicesfromTaiwan,HongKongandMacao;Theabbreviationofthepr

10、ovince,autonomousregionormunicipalitywheretheregistrationexaminationandapprovalauthorityislocatedshallbeadoptedforCategoryIImedicaldevices;Theabbreviationoftheprovince,autonomousregionormunicipalitywheretheregistrationexaminationandapprovalauthorityislocatedplustheabbreviationofthelocalmunicipalleve

11、ladministrativeareawithdistrictsshallbeadoptedintheformofXMforCategoryIdomesticmedicaldevices(onlytheabbreviationsofthelocalprovince,autonomousregionormunicipalityshallbeadoptedifthereisnocorrespondingmunicipalleveladministrativeareawithdistricts);>2shallindicatetheformofregistration(Zapproval,Ji

12、mportandXpermit):“Z"isapplicabletodomesmedicaldevices;“J"isapplicabletoforeignmedicaldevices;“X"isapplicabletomedicaldevicesfromTaiwan,HongKongandMacao;xxx>3shallindicatetheyearofapprovalforregistration;>4shallindicatethecategoryofproductadministration;x><5shallindicatethe

13、typecodeofproduct;andxxx>6shallindicatetheserialnumberofregistration.Themedicaldeviceregistrationrecord(seeAppendix1oftheseMeasures)attachedtoeachmedicaldeviceregistrationcertificateshallbeusedtogetherwiththemedicaldeviceregistrationcertificate.Article 6Amanufacturerapplyingformedicaldeviceregist

14、rationshallundertakethecorrespondinglegalobligationsandholdamedicaldeviceregistrationcertificateaftertheapplicationisapproved.Thepersonhandlingthemattersrelatedtoapplicationformedicaldeviceregistrationshallbesubjecttoauthorizationbythemanufacturer,havethecorrespondingprofessionalknowledgeandbefamili

15、arwiththelaws,rules,regulationsandtechnicalrequirementsontheadministrationofmedicaldeviceregistration.Regardingapplicationfortheregistrationofforeignmedicaldevices,theforeignmanufacturershalldesignateanorganizationlocatedwithintheterritoryofChinatoactastheforeignmanufacturer'sagent,whoshallunder

16、takethecorrespondinglegalliability.TheforeignmanufacturershallalsoentrustacorporateorganizationthatislocatedwithintheterritoryofChinaandhasthecorrespondingqualificationsorentrustthemanufacturersorganinChinatoundertakeafter-saleserviceforthemedicaldevices.Article 7Themedicaldeviceunderapplicationforr

17、egistrationshallhaveanapplicableproductstandard,whichmayadoptanationalstandard,aprofessionalstandardoraregisteredproductstandardformulatedbythemanufacturer,buttheregisteredproductstandardshallnotbeinferiortotherelevantnationalstandardorprofessionalstandard.Registeredproductstandardsshallbeformulated

18、inaccordancewiththerequirementsofSFDAfortheadministrationofthestandardsofmedicaldevices.Article 8WhenamanufacturerappliesfortheregistrationofaCategoryIIorIIImedicaldevice,themanufacturershallsatisfytheproductionconditionsspecifiedbySFDAormeettherequirementsoftherelevantqualitysystem.Chapter 2. Testf

19、orMedicalDeviceRegistrationArticle 9CategoriesIIandIIImedicaldevicesaresubjecttoregistrationtestbythemedicaldevicetestorganizationsrecognizedbySFDAandtheGeneralAdministrationofQualitySupervision,InspectionandQuarantine.Suchmedicaldevicesshallbeprovedconformingtotheapplicableproductstandardsthroughte

20、stbeforethemedicaldevicesareusedforclinicaltrialoranapplicationissubmittedforregistration.ThelistofthemedicaldevicetestorganizationsrecognizedbySFDAandtheGeneralAdministrationofQualitySupervision,InspectionandQuarantine(hereinafterDecreeofStateFoodandDrugAdministrationNo.16Aug.9,2004referredto“medic

21、aldevicetestorganizations")willbeseparatelyannounced.Article 10ThemedicaldevicetestorganizationsshallconductregistrationtesttotheproposedproductsandissuetestreportswithinthescopeoftestapprovedbySFDAandtheGeneralAdministrationofQualitySupervision,InspectionandQuarantineandinaccordancewiththeprod

22、uctstandardsproposedbythemanufacturers(includingtheapplicablenationalstandards,professionalstandardsortheregisteredproductstandardsformulatedbythemanufacturers).Forthemedicaldevicesthathavenotbeenincludedintheauthorizedscopeoftestbythemedicaldevicetestorganizations,thecorrespondingregistrationexamin

23、ationandapprovalauthorityshalldesignateatestorganizationwiththenecessarytestcapacitytotestsuchmedicaldevices.TheregistrationtestofforeignmedicaldevicesshallbeconductedinaccordancewiththeRegulationsontheRegistrationTestofForeignMedicalDevices.Article 11Thetestedproductsinasameregistrationunitshallbet

24、ypicalproductsthatcanrepresentthesafetyandeffectivenessoftheotherproductsinthisregistrationunit.Article 12Thesimilarproductsmanufacturedbyasamemanufacturerwiththesamerawmaterialsmaynotbesubjecttobiologicalcompatibilitytestduringthebiologicalevaluationoftheproductsforre-registration,providedthatthepr

25、oductiontechnologyandtheexpectedpurposeoftheproductsremainunchanged.Thesimilarproductsmanufacturedbyasamemanufacturerwithrawmaterialsthathavepassedbiologicalevaluationmaynotbesubjecttobiologicalcompatibilitytestduringthebiologicalevaluationoftheproductsforregistration,providedthattheproductiontechno

26、logyandtheexpectedpurposeoftheproductsremainunchangedortherearenonewpotentialbiologicalrisks.Article 13ApplicationfortheregistrationofaCategoryIIorIIImedicaldevicemaybeexemptedfromregistrationtestifthismedicaldevicecansatisfyallthefollowingconditions:(1) Thebasicprinciple,mainfunction,structure,mate

27、rial,materialqualityandexpectedpurposeofthemedicaldeviceunderapplicationforregistrationaresameasthoseofthemanufacturermedicaldevicethathasalreadybeenapprovedforregistration;(2) Themanufacturerhaspassedtheexaminationofqualitymanagementstandardformedicaldevicemanufacturingorhaspassedthecertificationof

28、qualitysystemformedicaldevices,andthemanufacturercanprovideatestreportrecognizedbytheoriginalproductionconditionexaminationauthority;(3) Themedicaldeviceunderapplicationforregistrationhasseennochangesrelatedtosafetyandeffectivenessascomparedwiththemanufacturer'ssimilarproductthathasalreadybeenap

29、provedforregistrationandhaspassedregistrationtest,orthoughtherearechangesrelatedtosafetyandeffectiveness,thechangedpartsandtheotherpartsoftheproductwithsubsequentchangesrelatedtosafetyandeffectivenesshavepassedtestbyamedicaldevicetestorganization;(4) Themanufacturer'similarproductthathasalreadyb

30、eenapprovedforregistrationhasseennoadverseeventsduringthemonitoringoftheadverseeventsofmedicaldevicesinaccordancewiththerelevantregulations;(5) Themanufacturer'similarproductthathasalreadybeenapprovedforregistrationhasnorecordofnonconformitiesasdeterminedbythe(food)drugadministrationauthoritydur

31、ingselectiveexaminationforproductqualitysupervisionwithinoneyear;and(6) Ifthemedicaldeviceunderapplicationisaforeignmedicaldevice,thesaleofthemedicaldevicehasbeenapprovedbythemedicaldeviceadministrationauthorityoftherelevantforeigngovernment.Article 14Applicationforthere-registrationofaCategoryIIorI

32、IImedicaldevicemaybeexemptedfromregistrationtestifthismedicaldevicecansatisfyallthefollowingconditions:(1) Thebasicprinciple,mainfunction,structure,material,materialqualityandexpectedpurposeofthemedicaldeviceunderapplicationforregistrationaresameasthoseofthemanufacturersmedicaldevicethathabseaelnrea

33、apdpyrovedforregistration;(2) Themanufacturerhaspassedtheexaminationofqualitymanagementstandardformedicaldevicemanufacturingorhaspassedthecertificationofqualitysystemformedicaldevices,andthemanufacturercanprovideatestreportrecognizedbytheoriginalproductionconditionexaminationauthority;(3) Themedical

34、deviceunderapplicationforre-registrationhasseennochangesrelatedtosafetyandeffectivenessascomparedwiththeoriginallyregisteredproductthathaspassedregistrationtest,orthoughtherearechangesrelatedtosafetyandeffectiveness,thechangedpartsandtheotherpartsoftheproductwithsubsequentchangesrelatedtosafetyandef

35、fectivenesshavepassedtestbyamedicaldevicetestorganization;(4) Themedicaldeviceunderapplicationforre-registrationhasseennoadverseeventsduringthemonitoringoftheadverseeventsofmedicaldevicesinaccordancewiththerelevantregulationswithinthevalidperiodoftheoriginalmedicaldeviceregistrationcertificate;and(5

36、) Theoriginallyregisteredmedicaldevicehasnorecordofnonconformitiesasdeterminedbythe(food)drugadministrationauthorityduringselectiveexaminationforproductqualitysupervisionwithinoneyear.Article 15Anapplicationforthepostponementoftestmaybesubmittedforlargemedicaldevicesthathaveobtainedsalesapprovalfrom

37、themedicaldeviceadministrationauthorityoftherelevantforeigngovernment,havespecialrequirementsforthesiteofinstallationandaredifficulttobetested,andsupplementarytestshallbeconductedforsuchmedicaldevicesafteramedicaldeviceregistrationcertificateisobtained.Foraproductthatisunderapplicationforthepostpone

38、mentoftestandhasbeenapprovedforregistrationinaccordancewiththeprovisionoftheaboveparagraph,themanufacturermustcompleteregistrationtestafterthefirstmedicaldeviceisimportedandbeforethemedicaldeviceisputintouse.Themedicaldeviceshallnotbeuseduntiltheendofsatisfactorytest.Chapter 3. ClinicalTrialofMedica

39、lDevicesArticle 16ClinicaltrialdocumentsshallbesubmittedforapplicationfortheregistrationofCategoriesIIandIIImedicaldevices.ClinicaltrialdocumentsshallbesubmittedinthemannerspecifiedintheClassifiedRegulationsonClinicalTrialDocumentsforMedicalDeviceRegistration(seeAppendix12oftheseMeasures).Article 17

40、TheRegulationsontheClinicalTrialofMedicalDevicesshallbestrictlyfollowedforthemedicaldeviceswhoseclinicaltrialisconductedwithintheterritoryofChina.Article 18TheclinicaltrialdocumentsforamedicaldevicewhoseclinicaltrialisconductedwithintheterritoryofChinashallincludeacontractforclinicaltrial,aplanofcli

41、nicaltrialandareportofclinicaltrial.Whenit'snecessaryatthe(food)drugadministrationauthority'sdiscretion,the(fdrugadministrationauthoritymayaskthemanufacturertosubmittheinstructionsonclinicaltrial,theletterofconsenttoclinicaltrialandtheoriginalrecordofclinicaltrial.Chapter 4. Applicationforan

42、dExaminationandApprovalofMedicalDeviceRegistrationArticle 19Toapplyformedicaldeviceregistration,theapplicantshall,accordingtotheclassificationofmedicaldevices,submitanapplicationtothecorresponding(food)drugadministrationauthorityinaccordancewiththeprovisionsofArticle4oftheseMeasures.Theapplicantshal

43、lcompleteawrittenapplicationformedicaldeviceregistrationandsubmitapplicationdocumentsinaccordancewiththecorrespondingrequirementsofAppendix2,3,6,8or9oftheseMeasures.TheapplicationdocumentsshallbemadeinChinese;andtheapplicationdocumentstranslatedonthebasisofforeigndocumentsshallbeaccompaniedbytheorig

44、inaldocuments.ThemanualofmedicaldevicesubmittedbytheapplicantshallconformtotheRegulationsontheAdministrationoftheManuals,LabelsandPackingMarksofMedicalDevices.Theapplicantshallberesponsibleforthetruthfulnessofallthecontentsoftheapplicationdocumentssubmittedbyit.Article 20Aftera(food)drugadministrati

45、onauthorityreceivesanapplication,thisauthorityshalldisposeoftheapplicationrespectivelyaccordingtothefollowingcircumstances:(1) Ifthematterunderapplicationisbeyondthelimitsofthe(food)drugadministrationauthorityfunctionsandpowers,the(food)drugadministrationauthorityshallimmediatelydecidetorejecttheapp

46、licationandnotifytheapplicanttoapplytotherelevantadministrationauthority;(2) Iftheapplicationdocumentshavemistakesthatcanbecorrectedonthespot,the(food)drugadministrationauthorityshallallowtheapplicanttocorrectthemistakesonthespot;(3) Iftheapplicationdocumentsareincompleteordonotmeettherequirementsof

47、formalexamination,the(food)drugadministrationauthorityshallissueanoticeforthesupplementationorcorrectionofdocumentstotheapplicantonthespotorwithinfiveworkingdaystoinformtheapplicantofallthecontentsthatneedtobesupplementedorcorrectedonceandforall;theapplicationdocumentsshallbedeemedtohavebeenaccepted

48、fromthedateofreceiptifthe(food)drugadministrationauthorityfailstoinformtheapplicantofthecontentsthatneedsupplementationorcorrectionwithinthetimelimit;or(4) The(food)drugadministrationauthorityshallaccepttheapplicationdocumentsiftheapplicationdocumentsarecompleteandmeettherequirementsofformalexaminat

49、ionortheapplicanthassubmittedallthenecessarysupplementaryorcorrectivedocumentsinaccordancewiththerequirements.Afteracceptingorrejectinganapplicationformedicaldeviceregistration,the(food)drugadministrationauthorityshallissueanoticeofacceptanceoranoticeofrejectionthatisaffixedwiththe(food)drugadminist

50、rationauthority'sspecialsealanddalArticle 21Aftera(food)drugadministrationauthorityacceptsanapplicationformedicaldeviceregistration,the(food)drugadministrationauthorityshallconductsubstantiveexaminationoftheapplicationandmakeawrittendecisiononwhethertoregisterthemedicaldeviceunderapplicationform

51、edicaldeviceregistration.Iftheapplicationisprovedconformingtotheregulationsthroughexaminationandregistrationisapproved,the(food)drugadministrationauthorityshallissueamedicaldeviceregistrationcertificatetotheapplicantwithin10workingdaysafterthewrittendecisionofapprovalismade.Iftheapplicationisprovedn

52、onconformingtotheregulations,the(food)drugadministrationauthorityshallmakeawrittendecisionofnoregistration,indicatethereasonandinformtheapplicantofitsrighttoapplyforadministrativereconsiderationorbringanadministrativelawsuitaccordingtolaw.Article 22Themunicipallevel(food)drugadministrationauthorityo

53、fanadministrativeareawithdistrictsshalldecidetoapproveregistrationornotwithin30workingdaysafteracceptinganapplication.The(food)drugadministrationauthorityofaprovince,autonomousregionormunicipalityshalldecidewhethertoapproveregistrationornotwithin60workingdaysafteracceptinganapplication.SFDAshalldeci

54、dewhethertoapproveregistrationornotwithin90workingdaysafteracceptinganapplication.Iftest,expertevaluationorhearingisneededduringtheexaminationofanapplicationforregistration,theperiodoftest,expertevaluationorhearingshallnotbeincludedinthetimelimitspecifiedinthisArticle.The(food)drugadministrationauth

55、orityshallnotifytheapplicantofthesaidperiodneededbywriting.Article 23Applicationfortheregistrationofaforeignmedicaldevicethathasobtainednoforeignsaleslicenseformedicaldevicesshallbeexaminedinaccordancewiththerequirementsoftechnicalexaminationfortheregistrationofsimilardomesticproducts(SeeAppendixes8

56、and9oftheseMeasuresforthedocumentsthatneedtobesubmitted).Article 24Duringthetechnicalexaminationofapplicationdocumentsformedicaldeviceregistration,ifthe(food)drugadministrationauthorityfindsthatthemanufacturerneedstosupplementdocuments,the(food)drugadministrationauthorityshallissueanoticeforthesuppl

57、ementationofdocumentsonceandforall.Themanufacturershallfullysupplementthenecessarydocumentsonceandforallwithin60workingdaysinaccordancewiththerequirementsofthenotice.Theperiodusedforsupplementingmaterialsshallnotbeincludedinthetimelimitforsubstantiveexaminationbythe(food)drugadministrationauthority.

58、Theexaminationshallbeterminatedifthemanufacturerfailstosubmitsupplementarydocumentswithinthespecifiedtimelimitwithoutjustifiedreasons.DecreeofStateFoodandDrugAdministrationNo.16Aug.9,2004Article 25Incasetheexaminationofapplicationforregistrationisterminated,themanufacturershallputforthnonewapplicati

59、onwithinsixmonthsafterthetermination.Article 26Ifthemanufacturerhasanyobjectiontothecontentofthenoticeforsupplementingdocuments,themanufacturermayputforthitswrittenopinionstothe(food)drugadministrationauthoritywithinthespecifiedtimelimit,indicatethereasonofobjectionandprovidetechnicalsupportdocuments.The(food)drugadministrationauthorityshallmakeadecisionafterexaminingthedocumentssubmittedbythemanufacturer.Article 27Theregistr