GLOBAL TRADE POLICY IN THE MEDICAL DEVICES AND EQUIPMENT SECTOR: CASE STUDIES ON TRADE-DISPUTE ANALYSIS OF ORTHO-K LENS IMPORTS FROM SOUTH KOREA TO THE EU

Abstract

The article aims to identify key regulatory trends, risks, and resolution mechanisms in the international trade of orthokeratology (Ortho-K) lenses, focusing on production discipline and trade compliance in the European Union. It is determined that the current expansion of Ortho-K trade is associated with the increasing demand for non-surgical myopia correction and rapid technological development in South Korea. It is argued that international trade in Ortho-K lenses is becoming a vital component of the cross-border medical devices sector and will continue to develop in light of rising youth myopia rates and the preference for reversible vision correction solutions. However, the industry must overcome significant challenges to sustain growth. These include technical compliance with EU Medical Device Regulations (MDR), alignment with international standards (ISO 13485, CE marking), and adherence to ethical production practices as required by Trade and Sustainable Development (TSD) chapters of free trade agreements. Based on theoretical and empirical generalizations, the article concludes that Ortho-K lenses have strong explicit and latent potential in the European market, particularly for pediatric and occupational use. Still, trade discipline is likely to intensify in the form of safety recalls and labour compliance investigations. The study emphasizes that successful market integration depends on a country’s ability to meet not only product safety and performance requirements, but also evolving expectations for social responsibility and sustainable production. Two disciplinary cases involving Lucid Korea’s trade with EU partners are used to illustrate these dynamics in practice.