Entering the U.S. medical device market can be a game-changer for manufacturers worldwide —but it requires strict compliance with FDA regulations. For newcomers, understanding the basics of registration, listing, and the role of key players like the Initial Importer and U.S. Agent is essential. This guide breaks down the process in simple terms to help you build a strong foundation for regulatory success.

Read More

Entering the U.S. market for medical devices offers significant growth opportunities —but it also brings complex regulations. From simple thermometers to advanced infusion pumps, every product that meets the FDA’s definition of a medical device must comply with registration and listing requirements.

Read More

A US Agent for FDA compliance is a person or entity based in the United States designated by a foreign manufacturer to act as its local liaison with the Food and Drug Administration...

Read More

Importing medical devices and certain cosmetic products and devices —such as RF skin-tightening tools, laser tattoo removers, or LED phototherapy panels— into the United States demands more than just logistics.

Read More

Modern medical devices and certain cosmetic “devices” such as RF skin-tightening tools often rely on Bluetooth, Wi-Fi, or cellular connectivity. While the FDA safeguards their safety and efficacy, the Federal Communications Commission (FCC) governs radio frequency (RF) emissions and spectrum use.

Read More