The procurement of initial FDA regulated devices demands a meticulous understanding of the applicable regulations and processes. Importers must guarantee compliance with all relevant standards to effectively navigate the regulatory landscape. This guide will provide a in-depth overview of the key steps involved in the initial import of FDA regulate… Read More

The FDA offers an essential service known as the Initial Importer Service specifically for medical devices. This service is aimed at simplify and streamline the shipping process of overseas medical supplies into the United States. Importers registered with the FDA can take advantage of this initiative to ensure that their imported medical devices c… Read More