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FDA医疗器械收费标准.doc

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FDA医疗器械收费标准.doc

上传人:梅花书斋 2022/9/11 文件大小:125 KB

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FDA医疗器械收费标准.doc

文档介绍

文档介绍:工厂年费的付款方法和步骤

 Inordertopaytheannualestablishmentfee,firmsmustaccessthe
工厂年费的付款方法和步骤

 Inordertopaytheannualestablishmentfee,firmsmustaccessthe
DeviceFacilityUserFee(DFUF)Websiteat.
(FDAhasverifiedtheWebsiteaddress,butFDAis
notresponsibleforanysubsequentchangestotheWebsiteafterthis
documentpublishesintheFederalRegister).TheWebsiteincludesa
shortinteractivequestionnairetohelpyouascertainwhetheranannual

requiredtopayanannualestablishmentregistrationfee,youmustpay


paymenthasbeenprocessed,youwillbeissuedapaymentconfirmation
number(PCN).Youwillnotbeabletoregisteryourestablishmentif

annualestablishmentregistrationfeeisnotlegallyregisteredinFY
2012untilithascompletedthestepsintheparagraphsthatfollowto
registerandpayanyapplicablefee.((f)(2).)
 Companiesthatdonotmanufactureanyproductotherthanalicensed
biologicarerequiredtoregisterintheBloodEstablishment
Registration(BER)'sCenterforBiologicsEvaluationand
Research(CBER)willsendestablishmentregistrationfeeinvoices
annuallytothesecompanies.
StepOne--Su