Register Your Medical Device Establishment with The U.S. FDA
U.S. regulation consulting: determine device classification, registration route consulting service, application compilation and regulatory guidance;
Establishment registration for the medical devices that exempt from Premarket Notification;
From premarket notifications (510(k)) consulting to Quality Systems Regulation (21 CFR 820) implementation;
Prepare the 510(k) submission;
Handle FDA additional information requests.
Renew Your U.S. FDA Medical Device Establishment Registration
All medical device registration information must be verified with U.S. FDA annually between October 1st and December 31st of each year. GeBiao can help you renew your FDA registrations as well as facilitate payment to FDA of any necessary fees.
List Additional Medical Devices, Manufacturers, Importers or Proprietary Names with U.S. FDA
The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) requires companies to list new manufacturers (both domestic and non-U.S.), initial distributors (importers) or proprietary names with their Medical Device Establishment Registration. GeBiao can help you update your FDA registrations.
Order a Certificate of Registration
Companies registered with U.S. FDA often are asked by your customers and suppliers to verify your registration URN that allows their products to be sold to any company in the U.S. A Certificate of Registration URN printed by GeBiao serves to verify your compliance with the registration requirement of the U.S. Food, Drug and Cosmetic Act.