任何从事制造、制备、量产、复合或加工进口到美国的设备的外国企业都必须为该机构指定一名美国代理人（美国代理人）。
有关外国企业美国代理的信息使用FDA统一注册和上市系统（FURLS系统）以电子方式提交，并且是企业注册过程的一部分。每个外国机构只能指定一名美国代理人。外国机构也可以（但不被要求）指定其美国代理人为其官方通讯员。外国机构应提供美国代理人的姓名、地址、电话和传真号码以及电子邮件地址。
确定的美国代理人将被要求完成一个自动化流程，以确认他们已同意担任美国代理人。自动化流程会将电子邮件验证请求转发给美国代理。他们将被要求确认她/他同意代表外国机构担任代表/联络人。如果美国代理商拒绝同意（或未在 10 个工作日内回复），则将通知外国机构的官方代理/所有者运营商，并且必须指定新的美国代理以履行监管义务。
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.
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.
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.
美国代理人的责任 Responsibilities of a U.S. agent
美国代理人必须居住在美国或在美国设有营业地点，美国代理人不能使用邮政信箱作为地址。美国代理人不能只使用应答服务。他们必须有空接听电话，或者有员工在正常工作时间接听电话。
美国代理人的责任是有限的，包括：
协助FDA与外国企业沟通，
回答有关外国企业进口或提供进口到美国的设备的问题，
协助FDA安排对外国企业的检查，以及
如果FDA无法直接或迅速联系外国企业，FDA可能会向美国代理人提供信息或文件，此类行为应被视为等同于向外国企业提供相同的信息或文件。
请注意，美国代理人不负责根据医疗器械报告法规（21 CFR Part 803）报告不良事件或提交510（k）上市前通知（21 CFR Part 807，子部分E）。
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.
The responsibilities of the U.S. agent are limited and include:
assisting FDA in communications with the foreign establishment,
responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
assisting FDA in scheduling inspections of the foreign establishment and
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.
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).
BUREAUMED 美国办事处信息：
美国 (U.S)
BMC REGISTER INC.
13442 Blossom Avenue Apt 4A, Flushing, NY 11355
