U.S. FDA registration & U.S. Agent services · Casper, Wyoming, USA info@regovant.com+1 307-301-7465
Regovant LLCFDA Registration & U.S. Agent
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FDA Registration for Companies Outside the U.S.

Wherever your facility is, the U.S. rules are the same: register it with FDA and name a U.S. Agent. Choose your country for local details, or start your registration now. $269 per facility per year, U.S. Agent included.

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Americas

Canada

CFIA-licensed food, maple, seafood, snacks

With U.S. Agent $269

Mexico

Packing houses, salsas, snacks, tequila

With U.S. Agent $269

Brazil

Coffee, açaí, juices, cosmetics

With U.S. Agent $269

Colombia

Coffee, cacao, fruit, panela

With U.S. Agent $269

Europe

United Kingdom

Biscuits, tea, sauces, spirits

With U.S. Agent $269

European Union

Olive oil, cheese, chocolate, wine

With U.S. Agent $269

France

Wine, cheese, chocolate, cosmetics

With U.S. Agent $269

Germany

Beer, sweets, bakery, supplements

With U.S. Agent $269

Italy

Olive oil, pasta, cheese, tomato products

With U.S. Agent $269

Spain

Olive oil, wine, canned seafood

With U.S. Agent $269

Türkiye

Dried fruit, nuts, sweets, olive oil

With U.S. Agent $269

Middle East & Africa

United Arab Emirates

Dates, honey, spices, free zones

With U.S. Agent $269

Saudi Arabia

Dates, honey, coffee, spices

With U.S. Agent $269

Israel

Tahini, hummus, dates, olive oil

With U.S. Agent $269

Egypt

Herbs, spices, dates, frozen vegetables

With U.S. Agent $269

Asia

India

Spices, rice, tea, snacks, supplements

With U.S. Agent $269

Pakistan

Basmati rice, spices, mangoes, pink salt

With U.S. Agent $269

Sri Lanka

Tea, cinnamon, spices, coconut

With U.S. Agent $269

Vietnam

Seafood, cashews, coffee, pepper

With U.S. Agent $269

Thailand

Rice, canned seafood, fruit, coconut

With U.S. Agent $269

Malaysia

Palm oil products, cocoa, coffee, snacks

With U.S. Agent $269

Indonesia

Coffee, cocoa, spices, coconut

With U.S. Agent $269

China

Tea, seafood, sauces, ingredients

With U.S. Agent $269

Taiwan

Tea, tapioca pearls, sauces, noodles

With U.S. Agent $269

Japan

Sauces, tea, noodles, sake, canned foods

With U.S. Agent $269

South Korea

Kimchi, sauces, ginseng, K-beauty

With U.S. Agent $269

Oceania

Australia

Honey, macadamias, wine, supplements

With U.S. Agent $269

New Zealand

Mānuka honey, dairy, wine, seafood

With U.S. Agent $269

What applies in every country

  • Register each facility that makes, packs or stores food for the U.S. with FDA. Each address is registered separately.
  • Name a U.S. Agent located in the United States. Regovant does this for you.
  • Have a D-U-N-S number for the facility's exact address. It is free from Dun & Bradstreet but can take weeks.
  • Renew on time: food facility registrations are renewed between October 1 and December 31 of every even-numbered year.
  • File Prior Notice for every food shipment before it arrives in the U.S.
  • Label in English: all information FDA requires must appear in English, in the U.S. format.

Cosmetics, medical devices and drugs have their own FDA registrations. See cosmetics (MoCRA), medical devices and drugs.

Questions

Are the FDA rules different for each country?

No. The same U.S. rules apply to every facility outside the United States: register with FDA, name a U.S. Agent, renew on time and file Prior Notice for each shipment. Our country pages explain how this fits with your local authority and common local questions.

My country is not listed. Can you still help?

Yes. We register facilities in any country and act as U.S. Agent for them. Start your registration or ask us a question, and we reply within one business day.

Does my local food authority approval replace FDA registration?

No. Approvals at home cover your own country. To sell food in the U.S., each facility that makes, packs or stores it must also be registered with the U.S. FDA.