Exporting a medical device to USA has to complete “Establishment Registration”.
Annual Medical device Establishment Registration information should be submitted to FDA between October 1 and December 31, even if no changes in the registered address and products
The medical device establishment registration is a two-step process.
Foreign facilities must pay annual registration to FDA to complete the registration process. The registration is not complete unless you have and US Agent.
Following are the steps for Medical device Establishment registration.
- US Agent Appointment
- User fee payment to FDA
- Device Listing
Medical Device Listing should be completed within 30 days of completing the establishment