Navigating FDA Requirements for Importing Medical Devices

The FDA’s “Importing Medical Devices” guidance explains what manufacturers and distributors must do before medical devices can enter the United States. The agency defines a medical device broadly as any instrument, apparatus, implant, reagent or similar article intended to diagnose, cure or prevent disease or affect the body’s structure or function without primary chemical action. If a product meets this definition, it is regulated as a medical device and must comply with FDA laws before, during and after importation. The page directs companies to resources that help determine whether a product is a device and clarifies that unclassified products can be reviewed under Section 513(g) of the Federal Food, Drug, and Cosmetic Act.

At the time of importation, FDA entry reviewers verify compliance with several requirements, including proper registration and annual listing of establishments, accurate device listing, and, when applicable, valid premarket submissions such as 510(k)s or premarket approval (PMA). Reviewers check the declared manufacturer, importer, product description and affirmation‑of‑compliance codes against the agency’s internal data systems; accurate entry data and relevant codes increase the chance that a shipment will be processed electronically without manual review. If information doesn’t match or if a device lacks required registration, listing or premarket clearance, the FDA may request additional information, detain the product or refuse entry. The guidance also explains that devices fall into Class I, II or III, with higher classes requiring more rigorous premarket submissions, and it provides links to classification and registration databases so importers can determine the necessary submission type before shipping.