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GeBiao is a Reliable U.S. Agent to Represent Your Medical Device Products.

 

FDA required that any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States agent (U.S. agent) for the establishment.

 

  • Each foreign establishment may designate only one U.S. agent;

  • The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent;

 

Responsibilities of GeBiao as Your U.S. Agent

 

  • Assist FDA in communications with the foreign establishment;

  • Respond to questions concerning your devices that are imported or offered for import into the United States;

  • Assist FDA in Quality System Regulation (QSR) scheduling inspections of the foreign establishment;

  • 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;

  •        Alert your company of new regulations as required.


Change U.S. FDA Official Correspondent and U.S. Agent

 

The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent.

It is prudent to separate commercial relationships from the responsibilities of your Official Correspondent for U.S. FDA communications because of potential conflicts of interests. Correct this by designating GeBiao as your Official Correspondent for U.S. FDA Communications and receive your Certificate of Registration issued by GeBiao.

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