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Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.

任何從事進口到美國的設備的生產、制備、傳播、合成或者加工的外國企業須為該企業確定美國代理人。

Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

外國企業美國代理人信息通過FDA統一注冊和登記系統（即FURLS系統）以電子方式提交，這是企業注冊過程的一部分。每個外國企業只能指定一名美國代理人。外國企業也可以指定美國代理人作為其官方聯系人，但這并不是強制性的。外國企業需要提供美國代理人的姓名、地址、電話、傳真號碼和郵箱地址。

The U.S. agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the U.S. agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the U.S. agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new U.S. agent to satisfy the regulatory obligation.

所指定的美國代理人需完成一個自動化流程，以確認他們同意擔任美國代理人。該自動化流程將向美國代理人發送電子郵件驗證請求。他們將被要求證實她/他同意成為代表國外企業的代表/聯絡人。若美國代理人拒絕同意（或在10個工作日內未作出答復），則將通知外國企業的官方聯系人/所有者運營商指定新的美國代理人以履行監管義務。

Responsibilities of a U.S. agent

美國代理人職責

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

美國代理人須居住在美國或在美國保持營業場所。美國代理人不能使用郵局信箱作為地址。美國代理人不能只使用應答服務。他們必須能夠接電話，或者在正常工作時間有員工可以接電話。

The responsibilities of the U.S. agent are limited and include:

美國代理人的職責是有限的，包括：

· assisting FDA in communications with the foreign establishment,

· 輔助FDA跟國外企業的溝通，

· responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,

· 就國外企業進口到美國或者提供進口到美國的器械的問題做出回應，

· assisting FDA in scheduling inspections of the foreign establishment and

· 協助FDA安排對外國企業的審查以及

· if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

· 若FDA不能直接或迅速地與外國企業聯系，FDA可以向美國代理人提供信息或文件，此類行為應被等同視為向外國企業提供相同的信息或文件。

Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

請注意：根據《醫療器械報告條例》（21 CFR部分803），美國代理人對不良事件的報告或遞交510(k)上市前通告（21 CFR部分807，子部分E）負有任何責任。