How do I register with the US FDA?

To export food, cosmetics, and medical devices to the United States, you must register your company and product information with the FDA (U.S. Food and Drug Administration). Without FDA registration, customs clearance will be denied by U.S. Customs.

The items managed by the FDA are more numerous than you might think. They include food (including dietary supplements and nutritional supplements), cosmetics (skincare, makeup, hair products), medical devices, pharmaceuticals, and even animal feed.

Food export procedures are simpler than you might think. Just remember these three steps: facility registration, designating a US Agent, and pre-notification.

Starting in 2024, U.S. cosmetics regulations are undergoing significant changes. Under MoCRA (Modernization of Cosmetics Regulation Act), facilities and products must now be registered with the FDA. This is the largest overhaul in 86 years.

Medical devices are categorized into Class I (low risk), Class II (moderate risk), and Class III (high risk) based on their level of risk. The required procedures and costs vary significantly depending on the class.

The FDA registration requirements for food, cosmetics, and medical devices vary. Check where your product falls and get prepared.

FDA registration is a specialized area. If it's difficult to proceed alone, actively utilize government support and professional agencies.