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CFDA Registration for Medical Devices & Cosmetics in China
EnteringtheChinesemarketcanbecomplicatedforforeignexporters,asChinahasmanydifferentrulesandregulations.Medicaldeviceandcosmeticscompanies,mustobtainaCFDAlicensebeforetheycanentertheChinesemarket.
TheCFDA(ChinaFoodandDrugAdministration)isresponsiblefortheregulationsandmanagementofmedicaldevicesandcosmeticinChina.Theimportregulationsformedicaldevicesandcosmeticsareverydifferent.ResearchinghowtogetaCFDAlicenseisthefirstthingexportersofmedicaldevicesandcosmeticsneedtodo,becausethisstepisverytimeconsuming.
CFDA Registration for Medical Devices
RulesenforcedbytheCFDAhavethepurposetoensure,thesafetyofconsumershealth.TheCFDAdiffersbetweenmedicalandbeautydevices.Themaindifferencebetweenthetwois:Beautydevicescanbeusedathome,andtheconsumerdoesn’tneedanyspecialknowledgerequiredforusingtheproduct.Medicaldevicesareusedbyindustryprofessionals.Medicaldevicesaredividedintothreedifferenttypes,dependingonthedevicesfunctionandtheriskforconsumers.ThefirstclasscanbeexaminedbytheCFDAbyroutinecheck,eventhoughitismerelya“routinecheck”ittakesupto9-12months.Thesecondclassisformedicaldevicesthatneedstobefurtherexamined,toensurethattheydonotposesariskforconsumers.Thesecondclassusuallytakes20-24monthstogetapproved.Lastisthethirdclass,whicharedeviceswhichpossesapotentialriskthesedevicesmustbeheavilycontrolledbeforeenteringthemarketusuallytheprocessingtimeforthesemedicaldeviceswilltakeupto30-36months.Giventheprocessingtimeformedicaldevices,theymustapplyfortheCFDAlicensefarinadvance,potentialdistributorswillhavetobeensuredthatthemedicalcompanyhasalicense,beforetheyarewillingtodoanybusiness,
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