FDA Registration and Listing

Description

Our FDA Registration and Listing Services help you register your establishment with the FDA and classify and list the devices that the facility will be offering for export to the United States. There are a number of important steps that need to be followed to expedite this process

The facility may engage the US Agent to help them with any of these processes

• The foreign establishment must obtain a DUNS number.  You can learn more about it here
• The U.S. Agent may assist in locating an initial importer and determining their fees and contract terms
• The manufacturer must fund the Annual Registration Fee, U.S. Agent fee and Initial Importer fee
• The U.S. Agent will set up the initial account in FURLS for the foreign manufacturer and assist in the paying the FDA the annual registration user fee. The payment process is faster when paid from a US Bank account.
• The U.S. Agent helps facilitate the payment of the Initial Importer so they can be selected during the registration process
• The U.S. Agent may assist the facility in filling out the establishment registration and completing the s U.S. Agent selection process
• The U.S. Agent assists in the selection of products that are able to be listed (exempt products). These are products that only require a device listing but no 510(k) or premarket approval. Those products can be listed right away

The official registration number may take 30 days to be received, however once the registration is submitted the company can export those devices that only require registration and listing.