Any manufacturer or importer intending to import a medical device into the United States requires a US FDA Agent, if there is no presence of company in the United States.
Pre-Requisites/Qualifications to Act as the US FDA Agent
As a prerequisite for providing the FDA Agent Services, he/she must be a resident of the United States or have a physical place of business in the U.S.
- Assisting the FDA in communications with your company
- Responding to the queries related to the imported products sold in the U.S.
- Helping the FDA in scheduling the inspections to your facilities
- As your U.S. Agent, freyr serves as a liaison between your company and The FDA
- Assistance in compliance with FDA norms
- Expert And dedicated team to handle your Regulatory responsibilities
- Provision of single source for representation in all the markets
- In case the US FDA is unable to contact you directly, then any document or information provided by the US FDA will Be considered equivalent to providing the same information or documents to your company