FDA Registration

We provide assistance in the registration process of import companies and foreign suppliers located outside the United States, complying with all U.S. Food and Drug Administration (FDA) and FSMA regulations.

I WANT TO ENTER THE U.S. MARKET

Do I have to register my foreign company to sell and/or commercialize my products in the United States?

In order to sale or commercialize within the United States; any company that manufactures, handles packages, and stores food, beverages, drugs or medical devices for human or animal consumption, must register with the FDA and follow the certification process for the product.

Companies located outside the United States must have a Registered Agent (US company), to establish a direct communication channel with the FDA.

FDA REGISTRATION

If you manufacture, handle, pack, and store any product related to the following:

• Food and beverages
• Cosmetics
• Medication/Drugs
• Medical Devices
• Dietary Supplements

You must initiate the FDA registration process and follow an approval procedure. Upon receiving certification for the product, it will be authorized admission for distribution and sale in the United States.

What is an FDA Registered Agent?

The Registered Agent in the United States oversees receiving all notifications and requirements the FDA may have or further need from foreign companies or suppliers.

The agent is a person or entity located within the United States. The FDA will communicate with this designated agent, so he or she must always be available and reachable.

REGISTRATION REQUIREMENTS

• The company must be incorporated and established in its country of origin
• A Procedure Manual is required
• There must be a designated Agent before the FDA
• Completion of an FDA Registration Form