FDA Registration

Register your company and obtain the FDA number required to sell your products in the United States in 24 hours.

FDA registration service includes:

• Registration number

• U.S. Agent service

• Customer Support

• FDA Communications Support

• DUNS number assistance

The service and registration expire globally at the end of each even-numbered year.

All-inclusive fee: $169.00 US (expires on December 31st, 2024)

ATTENTION: According to recent regulatory changes, the U.S. Food and Drug Administration now requires all companies to obtain a UFI (Unique Facility Identifier) before issuing an FDA Registration Number. It will not be possible to renew or create a new Food Facility Registration if the company does not have a UFI. Currently, the only acceptable UFI is the DUNS number, issued by Dun & Bradstreet.

MTCB provides its customers with free assistance in obtaining the DUNS number.

FAQs

What’s the FDA Food Facility Registration?

FDA registration consists of a registration of the establishment involved in the trade of food, drugs, and other particular products, such as medical devices or tobacco derivatives. Registration must be done with the Food and Drug Administration (FDA): the agency that deals with the regulation of food and drugs in the United States of America.

Which companies need to register and obtain the FDA number?

Currently, the following must be registered with the FDA for companies based inside or outside the U.S.:

• Companies that manufacture, process, label, package, or distribute food for human or animal consumption in the U.S.;

• Pharmaceutical companies that produce, process, package, or market products for the US market;

• Companies that manufacture medical devices and Radiation Emitting Devices for the U.S. market;

• Companies that manufacture or market tobacco products for sale in the United States.

What’s a U.S. Agent?

A U.S. Agent is a fundamental figure for correctly carrying out the FDA registration of companies. He is a person who maintains an office in the United States, acting as a reference in case of communications (for example: in case of controls) from the Food and Drug Administration. Companies located outside the United States necessarily need a U.S. Agent.

Do you have an office in the U.S.?

Yes, we do have an office in the USA.

How long does it take to get FDA registration?

MTCB generally completes the registration in 24 hours.
In case your company is not present in the DUNS database and therefore does not have a DUNS number, registration may take 7 - 14 days, the time required for the issue of the DUNS number. In this case, you will be promptly notified so you can keep that into account if you decide to register.

How does the registration take place?

After carrying out a brief telephone conversation with the applicant company, the documentation to be filled in with all the details relating to the activity carried out will be delivered. After that, the registration will be activated, usually within 24 hours.

how much does it cost?

The registration service, including U.S. Agent service, support, and FDA communications assistance until the expiration date of December 31st, 2024 is $169.00 USD.

Fill in the form, we will contact you within 24 hours.

Other contacts:

• MT Consulting & Brokerage, LTD
  DNS House, 382 Kenton Road
  Harrow HA3 8DP
  United Kingdom

• Mail: info@mtconsultingltd.com