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China CFDA Regulatory Approval Process for Medical

Devices
ToseetheirproductstotheChinesemarket,medicaldevice
andIVDmanufacturerswillneedtoobtainChinaFoodand
DrugAdministration(CFDA)(formerlyStateFood&Drug
AdministrationorSFDA)approval.Findoutmoreaboutthe
CFDAapprovalprocessinChina(/resources/marketchina)by
readingordownloadingthechartbelow.
Pleasecompletetheformbelowtoemailthefiletoyourself.
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The China (CFDA) medical device approval process explained

ThechartshownillustratestheCFDAapprovalprocessinChinaandisavailablefordownload
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inPDFformat.However,ifyouwouldliketoexplainthestepstosomeoneelseinanemail,you
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cancutandpastethetextbeloworsendthemalinktothispage.

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Step1
DetermineclassificationofyourmedicaldeviceinChinausingtheChinaFoodandDrug
Administration(CFDA)(/resources/regulationschina)OrderNo.15andCFDA'sclassification
database.ClassIIandIIIdevicemanufacturersshouldalsoidentifypredicates,aswellas
determinetheclinicaldatarequirementsandhowtosatisfythem.
Step2
AppointanAgentlocatedinChinawhowillcoordinateyourCFDAdeviceregistrations.
Step3
DemonstrateproofofhomecountryapprovalusingaCertificateofFreeSale(CFS)
(/services/worldwide/certificatefreesale)orCertificatetoForeignGovernment(CFG)
(/services/worldwide/certificatetoforeigngovernment).
Step4
Manufacturersmustsubmitanotarized"proofofqualificationofthemanufacturer."Common
waystosatisfythisrequirementinclude:ISO13485(/services/worldwide/iso13485consulting)
certificateEstablishmentRegistrationfromtheFDAforUScompaniesorManufacturing
LicenseforJapaneseorKoreancompanies.
Step5
PrepareTechnicalRequirementdocument.ForClassIIandIIIdevices,includedetailsof
additionaltestingtobeconductedinChina.*
Step6
ForClassesIIandIII,senddevicestoChinafortestingtobecarriedoutbyaCFDAauthorized
laboratory.Paytestingfees.
Step7
FordeviceswhichareclassifiedinClassesIIandIIIandarenotonaclinicaltrialexemptionlist,
prepareChinaClinicalEvaluation.**Datafromclinicaltrialsconductedmayberequiredfor
manydevices.

Step8

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ForClassIdevices,preparetechnicaldocumentationforClassIsubmission.SubmittoCFDA
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(nosubmissionfees).AlldocumentsmustbeinSimplifiedChinese.ForClassIIandIIIdevices,

prepareRegistrationDossier.SubmittotheCFDAandpayfees.DossierincludestheTechnical
Requirementdocument,applicationfortheImportMedicalDeviceRegistrationCertificate
(IMDRC,i.e.registration),notarizedproofofqualificationofthemanufacturer,CFS/CFG,Agent
authorizationletter,testreports,ChinaClinicalEvaluation(ifrequired),andotherdocuments.All
documentsmustbeinSimplifiedChinese.
Step9
ClassIsubmissionsundergoanadministrativereview.ClassIIandIIIsubmissionswillhavea
fullapplicationreviewconducted.Thiswillincludeatechnicalandadministrativereview.Novel
andhighriskproductsmayalsobesubjecttoanExpertPanelMeeting.CFDAmayconductan
onsiteQMSauditofmanufacturingfacilities..
Step10
ClassIdeviceswhichpassCFDAreviewwillreceiveavoucher.Vouchersarepublishedonthe
CFDA'swebsiteanddonotexpire.ForClassIIandIIIdevices,CFDAissuesIMDRCfollowing
successfulreview.YourIMDRCcertificateisvalidfor5years.PlaceCFDAregistrationnumber
onyourdevicelabeling,includingonyourIFU/usermanual.
Step11
YouarenowapprovedtosellyourdeviceinChina.
*ForeigntestreportsaregenerallyacceptedforClassIdevicesClassIIandIIIdevicesrequireacombinationofforeignandlocaltestreports.
**TheCFDArequiresaClinicalEvaluationforallClassIIandIIIdevices,unlessexempted.TheChinaClinicalEvaluationisuniqueandsignificantlymore
robustthanaCERsubmittedintheEUorUS.CERdatasuppliedforthesemarketswillgenerallynotbesufficientforChina.Askusfordetails.

Thisisasimplifiedoverviewoftheprocess.TheCFDAmaychoosetoaudityoursubmission
andrequestmoredocuments,whichwilladdtimetoyourapproval.

Chartupdated:31/03/2016

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