Foreign suppliers must first register with the United States Food and Drug Administration (FDA). Also, there is a listing requirement for medical devices and drug products. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577 https://www.m.itbhdg.com/compliance/