Medical Device U.S Agent Services

A U.S Agent is necessary for all Medical Device Establishment that are engaged in manufacturing, packing and labeling of Medical Device products and importing these products into the United States must identify a United States Agent (U.S Agent) .

There are 4 responsibilities of a U.S Agent are limited and include: 

1. assisting FDA in communications with the foreign establishment 
2. responding to questions from the FDA concerning the foreign establishment that imports into the U.S.
3. assisting FDA in scheduling inspections of foreign establishments.
4. if FDA is unable to contact the foreign establishment directly or expeditiously , FDA may provide information or documents to the U.S Agent , and in such action should be considered to be equivelant to providing the same information or documents to the foreign establishment. 

“FDA Registration Assistance’ is commited to providing the best service to you and your company. To appoint us as your United States Agent please CONTACT US.