Medical Device Requirements in Korea

(ITA) The Department of Commerce’s International Trade Administration (ITA) helped U.S. medical device manufacturers overcome a Korean regulatory trade barrier that imposed onerous registration requirements on U.S. medical devices.

Why it matters

Without ITA’s assistance, U.S. companies with global supply chains would have been forced to register products by country of origin. This would have put them at a disadvantage compared to their domestic competition and prevented them from accessing Korea’s multi-billion dollar medical device market.

Problem

In 2009, South Korea’s Food and Drug Administration (KFDA) implemented regulations that required companies to register their goods by country of origin as a means of receiving approval. This resulted in costly redundancies as many U.S. companies with shifting global supply chains and were required to repeat the registration process if they relocated their production to a different country. As we noted previously, this put them at a severe disadvantage vis-à-vis Korean firms. Korea’s actions raised concerns under the World Trade Organization’s Technical Barriers to Trade Agreement, which requires that such regulations not be unnecessarily trade restrictive. AdvaMed, an association representing U.S. medical device companies, contacted ITA for assistance after it failed to receive a response from KFDA.

Solution

ITA, working closely with other U.S. Government agencies and AdvaMed, raised industry’s concerns with KFDA and successfully persuaded it to revise the relevant implementing regulations. Foreign medical device manufacturers and importers no longer need to re-register their products if they choose to relocate their production to another country.

Working closely with U.S. companies, ITA creates, expands and defends market access for U.S. goods and services overseas through the Trade Agreements Compliance Program. “We promote policy that develops a more favorable business climate for U.S. companies in global markets; we employ commercial diplomacy to resolve trade barriers; and we leverage our bilateral and multilateral trade agreements to ensure our trading partners live up to their commitments so that our businesses can compete on a level-playing field.” - Assistant Secretary for Market Access and Compliance, Michael C. Camuñez.