How do I export medical devices?
Korea's medical device industry is a strategically growing export sector in the global market, with world-class competitiveness across diverse fields including diagnostic equipment, dental devices, in-vitro diagnostic devices, surgical instruments, and rehabilitation devices. Korean medical devices receive high recognition in major markets including the US, EU, China, and Southeast Asia for their advanced technology, reasonable pricing, and stable quality. This guide provides practical information for Korean companies preparing medical device exports to understand regulatory frameworks in each country, establish efficient licensing strategies, and achieve successful overseas market entry.
Key Summary
The global medical device market is valued at approximately $580 billion as of 2024, with annual average growth of 5.5% projected through 2030, driven by an aging population increase, spread of chronic diseases, and demand for healthcare infrastructure modernization. Korean medical device exports set an all-time high of approximately $8 billion in 2023, and even after the explosive growth in COVID-19 in-vitro diagnostic kit exports, export diversification is being achieved in ultrasound diagnostic devices, implants, endoscopic equipment, and others. Major export countries are the US (25%), China (18%), Germany (8%), Japan (6%), and India (4%), in that order, with notable growth in Southeast Asian and Middle Eastern emerging markets. The proportion of Korean medical device companies with export ratios exceeding 40% of total sales is increasing, supported by the government's medical device export support policy and the Korea Health Industry Development Institute's (KHIDI) global expansion program. In-vitro diagnostics (IVD), digital healthcare, and AI medical devices are attracting attention as the next-generation growth drivers for Korean export medical devices.
Market Overview
The global medical device market is valued at approximately $580 billion as of 2024, with annual average growth of 5.5% projected through 2030, driven by an aging population increase, spread of chronic diseases, and demand for healthcare infrastructure modernization. Korean medical device exports set an all-time high of approximately $8 billion in 2023, and even after the explosive growth in COVID-19 in-vitro diagnostic kit exports, export diversification is being achieved in ultrasound diagnostic devices, implants, endoscopic equipment, and others. Major export countries are the US (25%), China (18%), Germany (8%), Japan (6%), and India (4%), in that order, with notable growth in Southeast Asian and Middle Eastern emerging markets. The proportion of Korean medical device companies with export ratios exceeding 40% of total sales is increasing, supported by the government's medical device export support policy and the Korea Health Industry Development Institute's (KHIDI) global expansion program. In-vitro diagnostics (IVD), digital healthcare, and AI medical devices are attracting attention as the next-generation growth drivers for Korean export medical devices.
Essential Certifications
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