Why do you need an FDA U.S. Agent?

U.S. Food & Drug Administration (FDA) requires you to appoint a United States Agent (FDA U.S. Agent) if:

    ✪    You are a Foreign Establishment (Located outside of United States) and

    ✪    You are engaged in:

          ✔ Manufacturing or

          ✔ Preparation or

          ✔ Propagation or

          ✔ Processing of a medical device that is

    ✪    Imported to the United States

 
Responsibilities of a U.S. Agent:

The responsibilities of U.S. Agent are limited and include:

    ✔    Assisting FDA in communication with your establishment

    ✔    Responding to questions concerning the devices that are imported or offered for import into the United States.

    ✔    Assisting FDA in scheduling inspections of your 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 or equivalent to providing the same information or documents to the foreign establishment.

Fees & Charges:

Contact us  for fees & charges..