May 2014

Authors: Seth J. Goldenberg, NAMSA and Yongha Na, Director, Medipert

Excerpt:

The Korean medical device market is growing rapidly and presents excellent opportunities in the area of development and distribution of medical devices. Understanding the device market in Korea is critical to making the best of these opportunities, as is a working knowledge of the device registration and licensing process there. Key steps for getting a device approved by Korea’s Ministry of Food and Drug Safety (MFDS) include 1) Establishing a license holder/distributor in Korea (application for licensing will be through this entity); 2) Testing your product at MFDS-sanctioned laboratories; 3) Submitting a technical file to MFDS (Class III or IV device) or to an MFDS-designated agent (Class II); and 4) Post-approval inspections. Once inspections are complete, product sales can begin.