FDA為何需要 US Agent?

US Agent 的責任?

美國代理的責任

任何國外企業設施從事食品或是醫療的製造、處理、傳播、加工,而其產品最終進口到美國,這些國外企業設施必須指定一位美國代理。國外企業設施的美國代理資訊,必須上傳到FDA的網站,這是註冊過程中不可或缺的資訊。任何國外企業設施都必須指定一位美國代理,而這位美國代理不必然是企業設施的官方發言人或者是聯絡人。企業設施在FDA註冊時,必須提供美國代理的名字、地址、電話號碼、傳真號碼,還有e-mail帳號。

FDA會通知被指定的美國代理相關註冊資訊,而這位美國代理必須同意接受國外企業設施的指定。他必須通過e-mail的連結同意代理。如果這位指定的美國代理不同意,或者十天之內沒有回應,FDA會通知相關的國外企業設施,他們必須另外指定美國代理以符合法規要求

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).