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FDA US Registration Agent

FDA Agents


U.S. Agent and Registration of Facilities Worldwide
for the United States Food and Drug Administration
Food facility login Register medical firm

FDA Registration and US Agent Representation.



It is our privilege to help companies worldwide do business in the USA. Our experience helps our clients with professional service to register your company with US FDA, classify and list your products and serve as US Agent. We provide efficient and personal service to you in complying with the registration requirements of the US FDA.

We are thankful for the kind words from a few of our clients, foreign and domestic:

"Thanks for your help, efficiency fast, impressive."

C Wen, Rende, TAIWAN"

"HOWWW That was Fast! Thanks for helping in this process, it was crucial for us to find someone that could help us with this a fast respounse and FDA Agents exceeded my expectations; it was not only fast but also easy and at a reasonable price. Thanks!"

A. Garza, Nuevo Leon, MEXICO"

"I would like to thank you very much for your swift and cost-effective services and will be very happy to recommend you. Some other companies I have been assisting have been using [other registrars/agents]and have found them costly and tardy compared to your highly efficient service!"


"I recommend "fdaagents" to all my friends! Fantastic, fast and professional services. They are working 100% for the clients interests and will not ask you for money if they consider that is not necessary. I am a very happy client. If you want a real help do not hesitate to contact them, nice, professional and helpful!"

Poltan Z., HUNGARY

"Thank you for all your help. We will look to you for additional assistance in any/all of our FDA needs. Thanks!!"

Jose C., [Drug Establishment Registration] NJ, USA

"Thank you so much for your extremely quick and efficient service. VERY IMPRESSED. Thanks again."


"It is so good to be dealing with a company that does what it promises, and does it so well. We can only thank you for the service that you have given and will gladly recommend your company to anyone looking for help with FDA registration. Regards."

Henry G., Dorset, UNITED KINGDOM

"Thank you very much Carl, excellent service¡¡¡¡ Servido compadrito¡¡¡¡¡"

Adolfo F., MEXICO

"Thank you so much for getting this updated so quickly for us Sandra! We appreciate it!"

Heidi B., Wisconsin, USA.

"Thanks for all of the staff in your company to help us to complete the [medical] registration. We are lucky to get you as our agent."

Benny L., Liaoning Province CHINA

"Thanks guys for such great service."

Kathy L., SK, CANADA

"Good afternoon Adrian. Thank you for your good services. We are very grateful for their quick response to us. God bless you."


  • Registers your domestic (US) or foreign (non-US) food or medical device or Drug facility with the FDA and provides Confirmation and, if applicable, US FDA Registration Number, and
  • Serves as your mandatory U.S. Agent required for foreign medical device or drug facilities under the laws and for food facilities Agent compliance is provided by US Agent Service, and
  • Includes all your qualified products in your registration as part of our registration processing

For FOOD and BEVERAGE and WINE companies, simply click "REGISTER FOOD" here or the "REGISTER FOOD" in the Menu above.

For MEDICAL DEVICE COMPANIES, the required ESTABLISHMENT REGISTRATION and MEDICAL DEVICE LISTING can be completed here. To start the process and complete the registration and listing forms, just click "REGISTER MEDICAL" here or in the menu above.

For DRUG COMPANIES, both Domestic or Foreign, please visit our "Contact" page to send us an email, and tell us your type of product or activity (example: sunscreen, hand sanitizers, API, Drug Analysis, etc.)

If you have any questions, simply visit our "Contact" page to send us an email


YES! You must register with the FDA and have a US Agent. Without your FDA Registration, your products will not be allowed into the USA and you are subject to civil and/or criminal penalties.

FDA Final Rules state: "FDA has determined that it will contact the foreign facility's U.S. Agent when an emergency occurs..." FDA Agents is an independent U.S. Agent, which means that others such as your competitors or importers do not become aware of what the FDA might be saying to you or asking you.

Since 2003, FDA Agents has served companies for FDA registration. We register foreign and domestic Food, Medical Device, or Drug Facilities with the FDA and serve as the U.S. Agent for foreign Medical Device or Drug facilities. For foreign food and beverage companies, FDA Agents utilizes US Agent Service to serve as U.S. Agent. Our Internet registration system is available 24 hours a day, 7 days a week. Working closely with our clients, FDA Agents is a private company qualified to register your Domestic or Foreign Food, Medical Device or Drug Facility and serve as your required U.S. Agent for foreign Medical Device Facilities and foreign Drug Facilities, and utilizes US Agent Service to serve as U.S. Agent, in compliance with FDA regulations.



  • FDA Agents handles FDA registrations: we register your food, medical device or drug facility with the FDA and advise of your mandatory FDA Registration Number;
  • FDA Agents serves as your mandatory "U.S. Agent" for foreign medical device or drug facilities; Agent compliance for foreign food facilities is provided by US Agent Service ("U.S. Agent" is not the same as the agent for customs or other import purposes; it is specific in the regulations and refers to a different person/company with different duties and responsibilities).
  • FDA Agents translates the registration questionnaire into your native language and translates it back into english for the FDA, as english is required by the FDA;
  • FDA Agents (and US Agent Service for food facilities) interacts between the FDA and you as your U.S. Agent for all alerts, notices and communications to comply with the Laws
  • FDA Agents (and US Agent Service for food facilities) CONFIDENTIALLY transmits all legally required notices and communications between the FDA and your food facility;


These are laws and regulations that you must comply with or your products will be refused entry into the USA. If the U.S. Government or the FDA suspects problems with your facility, they will contact you through your U.S. Agent. If news gets out that your facility or products may be involved, your business will suffer. We at FDA Agents have no other business except serving as YOUR U.S. Agent and we keep all communications between the FDA and you CONFIDENTIAL and PRIVATE. We only do FDA Registrations and have no other involvement in the food-import or medical-device or drug business.


By studying this site: FDA Agents registers your company. These laws are complex. If you fail to comply, your products will be denied entry into the U.S. and will be held at the port of entry at your expense until you do comply. Comply now, because without your FDA Registration Number, your shipments will not be allowed entry into the USA.

FDA Agents is a private company, not a part of, or affiliated with, the United States Government or the Food and Drug Administration.**