FDA Registration, Renewal, and Representation to Export to the United States Without Risks

FDA registration: the first step to exporting to the United States

This is the mandatory registration with the FDA for companies that manufacture, process, package, or store regulated products in the United States.

Identifies and regulates foreign facilities

Allows the FDA to oversee product safety

Essential requirement to export without restrictions

Who is required to register?

Any company that wants to sell products in the United States, such as foods, beverages, supplements, cosmetics, pharmaceuticals, and more.

The biennial renewal is a mandatory process that companies must complete every two years (even-numbered years) to keep their FDA registration active.

Keeps your company’s FDA registration current

Prevents your company from being blocked at customs

Ensures uninterrupted export operations

Who is required to renew?

All foreign companies registered with the FDA must renew their registration between October and December of even-numbered years.

Complying with the FDA is not only a legal requirement but also a competitive advantage. A valid registration allows you to:

Export without customs blocks or holds

Gain the trust of distributors and customers in the United States

Avoid penalties and delays in bringing your products to market

If you belong to any of these sectors, it is mandatory to register and have an FDA Agent: