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South Korea expands medical device manufacturing

August 1, 2024
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Why this is important to Wisconsin businesses: Wisconsin companies could find a wide range of opportunities, from supplying devices to providing clinical research.

The COVID-19 pandemic transformed South Korea’s medical device industry from import-dependent to a major exporter. But there’s still plenty of room for Wisconsin medical device companies to promote their products, and future prospects for supplying the telehealth sector.

According to South Korea’s Ministry of Food and Drug Safety, medical device production nearly doubled between 2019 and 2022, from $6.2 billion to $12.2 billion, as the country became a significant source for diagnostic kits during the pandemic. Exports increased 112% while imports rose 18% during that period.

China was a key supplier, particularly for specimen collection tools for the kits, but its role declined substantially as the pandemic crisis subsided. The U.S. remains the dominant medical device supplier to South Korea, with a market share of 40-50%, according to the U.S. Commerce Department’s International Trade Administration (ITA). U.S. manufacturers are valued for their higher-end products while domestic production in South Korea revolves mainly around lower- to mid-range devices, ITA said, in a December 2023 report.

Top prospects for Wisconsin companies are devices such as multifocal intraocular lenses, charged-particle accelerators, soft contact lenses, coronary artery stents, and diagnostic imaging equipment, ITA said.

One area that could be poised for significant growth is telehealth. Doctor-to-patient telehealth care is banned in South Korea. It was temporarily allowed during the pandemic but that ended on May 31, 2023. However, a limited pilot program began in June 2023 for older adults and people with disabilities who cannot visit health care clinics and for second-visit patients with infectious diseases or those living on remote islands. If the program expands over the coming years, it could present increasing opportunities for Wisconsin companies. In addition, as the government supports efforts to expand domestic production, U.S. companies may find opportunities to provide clinical research, product registration, medical device licensing, and market access services, ITA said.

Exporters should become familiar with South Korea’s requirements which include obtaining approvals from the Ministry of Food and Drug Safety and negotiating prices with the Korean Health Insurance Review and Assessment Service.

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