How is the DUNS Number Related to FDA Registration?

The export of products involves multiple stages, and in today’s world, ensuring safety is essential. Companies need to guarantee that their operations are transparent, reliable, and recognized on an international level. This is where the DUNS Number (Data Universal Numbering System) comes into play— a unique identifier assigned to businesses that can make a significant difference in international trade.

For companies that wish to export products to the United States, especially in regulated sectors such as food, beverages, cosmetics, and medical devices, complying with the Food and Drug Administration (FDA) regulations is essential. A key element in this process is the DUNS Number, which plays an important role in registering companies with the FDA and, ultimately, in the success of exports.

What is the FDA Registration?

The FDA Registration is a mandatory requirement for all companies that manufacture, process, package, or store food, beverages, cosmetics, or medical devices intended for the United States. This registration ensures that the FDA can oversee and monitor the products entering the U.S. market, ensuring that they meet the required safety and quality standards.

To register a company with the FDA, it is not only necessary to provide details about the entity, its products, and manufacturing procedures, but a DUNS Number is also required to uniquely identify the company.

How is the DUNS Number Related to FDA Registration?

The DUNS Number is mandatory in several types of FDA registrations, such as in the case of food and medical devices, to ensure that each company is uniquely and accurately identified. This relationship between the DUNS Number and FDA registration is a fundamental piece in facilitating the export process, and here’s how it impacts:

1. Unique and Verifiable Identification

The DUNS Number allows the FDA to have a reliable source of information about your company, verifying its existence and reputation through Dun & Bradstreet. When a company registers with the FDA using its DUNS Number, this number helps uniquely identify it, preventing duplications and errors in the records. This is particularly important for foreign companies looking to access the U.S. market and needing to establish credibility with authorities.

2. Registration of Foreign Facilities

For companies outside the United States that manufacture FDA-regulated products (such as food, beverages, medical devices, or pharmaceuticals), the DUNS Number is necessary to register manufacturing, processing, or storage facilities. The FDA uses this number to ensure that the company meets verification requirements, facilitating inspection and quality control.

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