US FDA NDC Code Registration


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US FDA NDC Code Registration Features included in your subscription: Registering a National Drug Code (NDC) with the U.S. Food and Drug Administration (FDA) is part of the drug listing process. The NDC is a unique identifier assigned to each drug product, and it is used for product identification and tracking in the United States. […]

US FDA Drug Import License Register


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Features included in your subscription: To import drugs into the United States, you must comply with the regulations set by the U.S. Food and Drug Administration (FDA). The FDA does not issue a specific “Drug Import License” but requires drug importers to register their establishments and follow specific procedures. Here’s an overview of the process […]

US FDA Agent Registration Service


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The U.S. Food and Drug Administration (FDA) requires foreign establishments that manufacture, process, pack, or store FDA-regulated products to have a designated U.S. Agent. The U.S. Agent serves as a point of contact between the FDA and the foreign establishment. Here is an overview of the FDA Agent service: 1. Purpose of the U.S. Agent: […]

US FDA 510 (k) Registration


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US FDA 510 (k) Registration Features included in your subscription: The U.S. Food and Drug Administration (FDA) 510(k) registration process is specifically related to the clearance of medical devices. The 510(k) pathway is used to demonstrate that a new medical device is substantially equivalent to a predicate device that is already legally marketed in the […]