FDA Registration

Establishment Registration. Device Listing.

Registration with the FDA is the first prerequisite for distributing or importing medical devices to the U.S.

Conditions for registration include:

  • Classification by product category
  • Device Listing (a list of all products that are to be imported into the U.S.)
  • Appointment of a U.S. agent (United States Agent)
  • Product approval submission for class II and II products

Foreign manufacturers of medical devices must name a “United States Agent” when registering in the U.S. The U.S. agent acts as a liaison between the FDA and the foreign company. Capamed Inc. assumes the role of “United States Agent”.

The Capamed Advantage:

  • Registration of the manufacturer with the FDA (Establishment Registration)
  • Product Classification and Device Listing
  • Instant availability of a U.S. agentfor foreign manufacturers
  • Preparation of your application for product approval