Facility Registrations for Medical Devices
FDA medical device facility registration/Device list registration,
US agent (FDA Agent)
What is FDA 510(k)?
U.S. and foreign businesses involved in the manufacture, distribution, etc. of medical devices sold in the U.S. are obligated/required to register facility information (Facility Registration) and device list (Listing) with the U.S. Food Drug Administration.
FDA medical device registrations must be renewed annually. In addition, there are a wide variety of facilities that require FDA medical device registration. In Japan, the system is divided into 4 categories (manufacturing and sales, manufacturing, repair, advanced medical equipment), but in the United States, there are 13 categories (manufacturing industry, export industry, etc.), and the system is different, so be careful.
U.S. Agent (FDA Agent)
Foreign facilities are required to appoint a US agent (US agent) with a US address. A US agent must be a US resident or a business establishment, and cannot be a PO Box or an answering machine. The US Agent acts as a point of contact for FDA communications to foreign facilities. You will receive important information such as FDA inspection notices and medical device questions.
Medical Device Facility Registration/
Device List Registration Support,
Registration Agency, U.S. Agent Agency
Globizz provides support for FDA medical device facility registration and device list registration, registration agency, and US agent agency. If you have any questions about FDA medical device facility registration, device list registration, or U.S. agents, please feel free to contact us.