The Spain U.S. Chamber Of Commerce

Services

Trade Information and Services : Agency Service for FDA purposes - Medical Devices

The Spain-U.S. Chamber of Commerce acts as an agent in compliance with the FDA regulations for medical devices. To learn more about this regulations, please visit the FDA web page, or the specific regulation page, http://www.fda.gov/cdrh/index.html 

Once you have reviewed these documents, and have decided that you would like to become a member in order to access this free service, please complete the send the following information:

  1. Annexes A and B: Information Sheet (in Spanish)
  2. Agency Contract, dated and signed

To become a member, please visit our Member Page.