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