进口医疗器械延续注册法规英文版Renewal of registration for overseas medical devices.docx
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进口医疗器械延续注册法规英文版Renewal of registration for overseas medical devices.docx
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进口医疗器械延续注册法规英文版Renewalofregistrationforoverseasmedicaldevices
Renewalofregistrationforoverseasmedicaldevices
I.Projectname:
initialregistrationofimportedmedicaldevices
II.Contentsoflicensing:
Renewalofregistrationforoverseasmedicaldevices
III.Basisforimplementation:
"RegulationsforSupervisionandAdministrationofMedicalDevices","ProvisionsforMedicalDeviceRegistration"
IV.Fees:
Nocharge
V.Quantityrestrictions:
Noquantitylimitforthelicensing
VI.Listofapplicationdocuments:
Datanumber
(1)Applicationformforregistrationofoverseasmedicaldevice;
Datanumber
(2)Medicaldevicemanufacturercertification;
Datanumber(3)Copiesoftheapplicant’sbusinesslicense,andthemanufacturersletterofauthorizationtoagentsforregistration;
Datanumber(4)Theoriginalregistrationcertificatesofmedicaldevices;
Datanumber(5)Documentsprovingoverseasmedicaldevicecompetentauthorities’approvaloradmissionofentryintothemarketofthecountry(region);
Datanumber(6)Applicableproductstandardsandinstructions;
Datanumber(7)Medicaldevicemanuals;
Datanumber(8)Productregistrationtestingreportissuedbymedicaldevicetestinginstitutions(forClassIIandIIImedicaldevices)
Datanumber(9)Productqualitytrackingreports;
Datanumber(10)Productwarrantyissuedbythemanufacturers
Datanumber(11)Manufacturer’spowerofattorneydesignatingChineseagents,theagent'sletterofcommitmentandbusinesslicenseorinstitutionalregistrationcertificate;
Datanumber(12)letterofentrustmentdesignatingafter-saleagenciesinChina,andtheagencies’letterofcommitmentandqualificationdocuments;
Datanumber(13)ForcircumstancesdescribedinArticle34ofthe"ProvisionsforMedicalDeviceRegistration",theapplicantshallprovidethecorrespondingexplanationsandcertifyingdocuments;
Datanumber(14)Self-assurancestatementofauthenticityofthedossierssubmitted;
Datanumber(15)Otherissues.
VII.Requirementsforapplicationdossiers:
(I)Generalrequirementsforapplicationdossiers:
1.Thefirstpageoftheapplicationdossiersshallbeadirectoryoftheapplicationitems,theorderofwhichshallbearrangedasperbyAnnexVIIofthe"ProvisionsforMedicalDeviceRegistration".Eachdossiershallhaveacoverpageindicatingthenameoftheproductandtheapplicant,andthedossiertitleshallbemarkedattheupperrightcorner.Thedossiersshallbedistinguishablewithclearmarkers,andthenameandserialnumberofthedossiershallbeindicated.Theentiredossiersshallbeboundintoabook.
2.TheapplicationdossiersshallbeinOnesetandprintedonA4paper,thecontentshallbecomplete,clear,andshallnotbealtered,thedocumentsissuedbytheGovernmentandotherinstitutionsshallbeprovidedintheoriginalsize.
3.Copiesofthedossiersshouldbeclear.
4.Theproductnamesinvariousitems(approvalsformarketing,standards,testreports,manuals)ofapplicationsdossiersshallcorrespondwiththenamesandsubstantialcontentsintheApplicationform.Tradename(ifany)shouldbemarked.TheapplicationdossiersshallbeinChinese,andtranslateddossiersshallbeaccompaniedwiththeoriginals.Chinesesignatureorsealfollowstheformatprescribedin[2004]Doc.No.499.
(II)Specificrequirementsforapplicationdossiers:
1.Applicationformforregistrationofoverseasmedicaldevice;
(1)Medicaldeviceregistrationapplicationformandthe"2010Electronicmedicaldevices(IVD)applicationsoftware(includingmanuals)"canbedownloadedat ;
(2)Medicaldeviceregistrationapplicationformisoneoftheimportantdataforregistrationapplication,thereforetheitemsshallcomplywiththerequirementsofinstructions.
2.Medicaldevicemanufacturercertification;
(1)Documentsprovingeligibilityinproducingmedicaldevices;
(2)Copiesshallbesignedandsealedbytheoriginalcertificateissuersornotarizedbythelocalnotaryorganizations;
(3)withinthevalidityperiod(ifany).
3.Copiesoftheapplicant’sbusinesslicense,andthemanufacturer’sletterofauthorizationtoagentsforregistration;
(1)copyofthebusinesslicenseoftheapplicant
①Copiesarepermissiblebutmustbestampedbythesealsofthecertificateholders;
②Andwithinthevalidityperiod.
(2)Letterofentrustmentforregistration
Shallbestampedbythemanufacturers.
4.Theoriginalregistrationcertificatesofmedicaldevices;
(1)ForcircumstancesdescribedinArticle33,Chapter5ofthe"ProvisionsforMedicalDeviceRegistration",acopyoftheoriginalregistrationcertificateofthemedicaldeviceshallbesubmitted;
(2)Forrenewofregistrationduetochanges,themanufacturershallsubmitacopyoftheoriginalregistrationcertificateofthemedicaldevice,whichshallbemarked“identicalwiththeoriginal”andstampedbythemanufacturer;andtheoriginalcertificateshallbereturnedwhilereceivingthenewones.Iftheoriginalregistrationcertificateislostordamaged,theapplicantshouldexplainthereasons.
5.Documentsprovingoverseasmedicaldevicecompetentauthorities’approvaloradmissionofentryintothemarketofthecountry(region);
(1)Copiesshallbesignedandsealedbytheoriginalcertificateissuersornotarizedbythelocalnotaryorganizations;
(2)withinthevalidityperiod(ifany).
(3)Suchasaddingnewspecifications,models,oradding/changinganewproductionsite.Certifyingdocumentsforadditionandchangeshallbeissuedbymedicaldeviceregulatoryauthoritiesofthecountry(region)ofoverseasapplicantsregisteredaddressorproductionsitestoallowthemarketingoftheproduct
6.Applicableproductstandardsandinstructions;
(1)Normativetext;
(2)Developmentinstructions(applicabletoregisteredproductstandards);
(3)Productstandardsanddevelopmentinstructionsshallbeinduplicate,togetherwithtwostatementsofstandardsconsistency(applicabletoregisteredproductstandards);
(4)Theappliedproductsshouldbeincludedintheproductstandardrange;
(5)Ifnationalandindustrystandardsareemployedasapplicableproductstandards:
①Themanufacturershallprovideastatementofcompliancewithnationalandindustrystandards,whichshallbestampedwiththeofficialsealofthemanufacturer;
②Astatementforbearingfullresponsibilitiesofthequalityofpost-marketedproductsproducedbymanufacturer,whichshallbestampedwiththeofficialsealthemanufacturer;
③Adescriptionofproductmodelsandspecificationclassificationsproducedbymanufacturer,whichshallbestampedwiththeofficialsealthemanufacturer.
(6)RegisteredproductstandardsshallbestampedwiththesealsofthemanufacturersortheirChineseagencies,ortheunitsentrustedbythemanufacturersfordraftingstandards,theletterofentrustmentshallindicatethat"themanufacturershallberesponsibleforproductquality",andstampedbythemanufacturer.
7.Medicaldevicemanuals;
(1)Productmanualsshouldbeprovided;omissionofwhichshallbeaccompaniedbyspecificationsissuedbymanufacturers,andstampedbythemanufacturer;
(2)TheproductmanualsofClassIIandIIImedicaldevicesshouldbesealedbythemanufactureroritsrepresentativeofficeinChina,whileClassImedicaldevicemanualscandowithoutseals.
8.Productregistrationtestingreportissuedbymedicaldevicetestinginstitutions(forClassIIandIIImedicaldevices)
(1)Thespecificationsandmodelsofthetestedproductsshouldbewithinthescopeoftheregistrationapplication;
(2)Testtypeshouldberegistrationtestornationalfull-performancesamplingtest;
(3)Originals;
(4)Shouldbewithinthevalidityperiod(asperArticle7inAnnexVIIofthe"ProvisionsforMedicalDeviceRegistration").
Note:
IftheArticle11,12and13ofthe"ProvisionsforMedicalDeviceRegistration"areimplemented,themanufacturershallprovideappropriatedocumentationstampedwithitsofficialsealorthesealsofitsChineseagencies.
(5)IftheArticle15ofthe"ProvisionsforMedicalDeviceRegistration"isimplemented,themanufacturershallapplyforsuspensionoftestandmakerelatedcommitments,whichshallbestampedwithitsseals.
9.Productqualitytrackingreports;
Shallbeissuedandsealedbytheagentofthemanufacturer
10.Productwarrantyissuedbythemanufacturers
Shallbestampedbythemanufacturers.
11.Manufacturer’spowerofattorneydesignatingChineseagents,theagent'sletterofcommitmentandbusinesslicenseorinstitutionalregistrationcertificate;
(1)Agent'sletterofentrustmentshallbesignedandsealedbythemanufacturer,andnotarizedbythenotaryorganizationinwhichcountry(region)itlocates.
(2)Letterofcommitmentshallbesignedandsealedbytheagent;
(3)Businesslicenseorregistrationcertificatesignedandsealedbycertificateowner.
12.Letterofentrustmentdesignatingafter-saleagenciesinChina,andtheagencies’letterofcommitmentandqualificationdocuments;
(1)Letterofentrustmentforafter-salesservicesignedandsealedbythemanufacturer;
(2)Letterofcommitmentsignedandsealedbytheagencyentrusted;
(3)Qualificationdocumentssignedandsealedbycertificate-ownedenterprises.
13.ForcasespertainingtoArticle34ofthe"provisionsforMedicalDeviceRegistration",theapplicantshouldprovidetheappropriatedocumentssignedandbythemanufactureroritsrepresentativeofficesinChina.
14.Self-assurancestatementofauthenticityofthedossierssubmitted;
(1)Issued,signedandsealedbythemanufactureroritsrepresentativeofficeinChina,andnotarizedinthemanufacturer’scountry(region);
(2)TheStatementshouldsubmitalistofdossiers;
(3)Includingacommitmentto
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- 进口医疗器械延续注册法规英文版Renewal of registration for overseas medical devices 进口 医疗器械 延续 注册 法规 英文 Renewal
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