FDA美国代理人_美国代理人/美代/US Agent办理费用及流程-需要什么材料

1.   FDA注册的日常维持，新；

2.   FDA较新动态的一时间告知及建议；

3.   随时为您提供与FDA注册和上市后监管等相关的事务的处理意见；

4.可代表您回答您美国客户的相关FDA问题（英文邮件，英文电话会议均可）；

5.接受FDA验厂时，以优惠的价格提供QSR820辅导、审核经验传授及全程英语陪审

6.选择有能力进行QSR820辅导（包括美国法规知识、国内审核经验和英语沟通能力）的美国代理人！

7.在完成注册后，启动QSR820体系，按照美国法规的要求实施管理，有备无患！

8.实在没有满足2条又被抽查到，立即联系我们，为你提供五天辅导方案确*审查！

提供医疗FDA注册，食品FDA注册、化妆品FDA注册，美国代理人服务、FDA验厂辅导、FDA警告性移除

FDA官方对于美国代理人的解释也可以参考看一下官网的原文：

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.

Responsibilities of a U.S. agent

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).

我公司办理医疗产品出口欧盟、美国、中东南美等国家的各种认证：