Martial Arts, 'FDA Expert Invited US Medical Supplies Export Webinar' Held

[Asia Economy Reporter Hwang Yoon-joo] The Korea International Trade Association held a webinar titled ‘U.S. Medical Device Export Procedures from the Perspective of U.S. Food and Drug Administration (FDA) Experts’ on the 3rd, broadcast simultaneously from Seoul and Washington.

The webinar, held via the Zoom video conferencing platform, featured Michael Hinkle, attorney at U.S. law firm K&L Gates; Park Sung-won, attorney at law firm Reed Smith; Moon Jeong-hwan, Washington Center Director of Korea Innovation Center; and Kim Hyo-jin, TradeSOS consultant at the association’s trade counseling desk. They shared information on FDA application and approval procedures, item-specific considerations, and support projects related to the Emergency Use Authorization (EUA).

Attorney Michael Hinkle explained, "The FDA determines regulation not based on the product or device itself but on the reason or purpose for which it was made," adding, "EUA is the authorization granted even for pharmaceuticals that do not meet FDA conditions in emergency situations like the current one," elaborating on the FDA’s authority, regulatory targets, and approval requirements.

Consultant Kim Hyo-jin stated, "Masks, gowns, gloves, and other personal protective equipment for general or industrial use fall under EUA and discretionary enforcement guidelines," providing detailed guidance on the list of applicable items and how to use the U.S. electronic import clearance system.

Cho Hak-hee, Director of the International Business Division at the Korea International Trade Association, said, "Since April, the association has been operating the Global Bridge Project, which delivers information on domestic medical and hygiene product exporters to overseas networks, striving to translate the high interest in K-quarantine into exports," adding, "We will continue to discover new support projects going forward."