美國FDA公布醫(yī)療器械產(chǎn)品2022年年費標(biāo)準(zhǔn)

2021-09-28 16:49

美國FDA公布醫(yī)療器械產(chǎn)品2022年年費標(biāo)準(zhǔn):The enterprise shall conduct annual registration for fiscal year 2022 within the annual registration time range from October 1 to December 31, 2021.

All establishments that are required to register, must pay the annual registration user fee using the Device Facility User Fee (DFUF) system. After paying the annual registration user fee and obtaining the Payment Identification and Confirmation Numbers (PIN/PCN), the annual registration must be completed using the FDA Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM.). The annual registration user fee for FY 2022 is $5,672. The Federal Register (FR) Notice announcing the fee can be found at: https://www.federalregister.gov/documents/2021/08/02/2021-16408/medical-device-user-fee-rates-for-fiscal-year-2022.

You must pay the annual registration user fee and complete the annual registration (a two-step process) using two different systems. Both steps must be completed for your establishment to be considered registered for FY 2022

企業(yè)應(yīng)在2021101日至1231日時間支付2022年美國FDA年費并進行企業(yè)資料更新,2022年美國FDA財年費用為5672美元。公布該費用的《聯(lián)邦公報》(FR)公告可在以下網(wǎng)址找到:

https://www.federalregister.gov/documents/2021/08/02/2021-16408/medical-device-user-fee-rates-for-fiscal-year-2022

    關(guān)于2022年美國FDA注冊官方年費詳情可咨詢400-611-6855聯(lián)系。


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