Registration Forms
Get Your Products Registered and Ready for the U.S. Market
To import and distribute your products in the U.S., the FDA requires specific registrations and listings. Please complete the relevant forms below so our team can help ensure your products meet all necessary compliance standards quickly and efficiently.
Drug Listing
Provide details about each drug product you intend to market in the U.S. This helps us prepare your submission to the FDA so your products are properly listed and cleared for distribution.
Drug Registration
Share your facility’s information to register as a drug establishment with the FDA. This is required before manufacturing, repacking, or importing drugs into the U.S. market.
Medical Device Establishment
Register your company and any manufacturing sites to comply with FDA requirements for medical device establishments. This step helps your devices enter the U.S. legally and safely.
Prior Notice
Complete this form to notify the FDA in advance of shipments of food products to the U.S. Prior notice is mandatory and helps avoid customs delays or holds.
Ready to Get Started?
Let Hykkon simplify your FDA and USDA registration process.
Complete the forms above or reach out to our expert compliance team today. Our team can help your products enter the U.S. market quickly, safely, and without hassle.
