FDA Registration

Certification Overview (Business Overview)

FDA (U.S. Food and Drug Administration) registration is a mandatory regulatory requirement for companies manufacturing, processing, packing, or holding products that enter the United States market — covering food, medical devices, cosmetics, radiation-emitting products, and pharmaceuticals. Failure to maintain valid FDA registration can result in product detention at U.S. ports, refusal of admission, import alerts, and enforcement actions.

NGV provides FDA registration agency services covering the full registration lifecycle:

Establishment registration: Creating and maintaining FDA-registered facility accounts; food facility registrations require biennial renewal during October 1 – December 31 of even-numbered years.

Product listing: Submitting product information, classifications, and labeling details to FDA databases.

U.S. Agent designation: Serving as or arranging the required U.S. Agent for foreign establishments — the designated contact point for FDA communications and regulatory inquiries.

Biennial renewal and updates: Managing ongoing registration maintenance, including changes to facility information, product listings, and compliance status.

Regulatory guidance: Interpreting FDA labeling requirements, testing mandates, good manufacturing practices (GMP), and import inspection procedures — helping clients understand and prepare for FDA expectations.

Scope of Certification

Food and beverage products: All human and animal food facilities must register with FDA under the Food Safety Modernization Act (FSMA). This includes manufacturers, processors, packers, and holders of food for consumption in the U.S.

Medical devices: Class I, II, and III medical device establishments — including manufacturers, contract manufacturers, specification developers, and repackagers — must register and list their devices with FDA.

Cosmetics: Voluntary registration under FDA's Voluntary Cosmetic Registration Program (VCRP); mandatory facility reporting and ingredient disclosure are required under MoCRA for cosmetic facilities targeting the U.S. market.