FDA / TFDA Registration
IMGT provides comprehensive regulatory support for FDA and TFDA registration in both the United States and Taiwan. Our services cover medical devices across Class I, II, and III, ensuring that clients receive appropriate guidance tailored to their product classification and regulatory pathway.
Obtaining FDA or TFDA approval is a critical first step for entering the U.S. and Taiwan medical markets. IMGT offers end-to-end support throughout the registration process—from regulatory strategy and documentation preparation to submission and communication with authorities—ensuring an efficient and compliant pathway to market entry.