South Korea’s medical device trade balance remained in surplus for the sixth straight year in 2025, reaching KRW 478.9 billion (USD 330 million), according to the Ministry of Food and Drug Safety (MFDS).
Domestic production totaled KRW 12.3558 trillion (approx. USD 8.6 billion), up 8.1% year-on-year. Exports rose 2.2% to USD 5.37 billion, while imports increased 9.3% to USD 5.04 billion.
After a sharp decline in 2023 due to the post-pandemic drop in diagnostic device demand, production and exports have rebounded since 2024. Production fell 28.1% in 2023, then grew 1.0% in 2024 and 8.1% in 2025. Exports declined 34.2% in 2023, then rose 1.4% in 2024 and 2.2% in 2025.
The domestic medical device market recovered to KRW 11.8769 trillion, up 12.6% year-on-year, returning to 2022 levels. The five-year compound annual growth rate stood at 6.8%.
In vitro diagnostics (IVD) also showed recovery. IVD production held steady at KRW 997.2 billion, while exports grew 6.0% to USD 738 million. Notably, production of high-risk infectious disease genetic test reagents surged 22.6% to KRW 327 billion, and exports rose 20.2% to USD 169 million. MFDS attributed this to a shift from COVID-19-focused products toward PCR-based diagnostics targeting gastrointestinal infections, HPV, and other non-respiratory diseases.
By product category, dental implants and ultrasound diagnostic devices led the market. Dental implant fixtures ranked first in production for the third consecutive year at KRW 2.4429 trillion, up 12.2%. General-purpose ultrasound imaging devices followed with KRW 753.8 billion.
In exports, general-purpose ultrasound imaging devices topped at USD 529 million, with dental implant fixtures second at USD 399 million.
Aesthetic medical devices showed strong growth. Production, exports, and imports of general electrosurgical units used for skin wrinkle improvement rose 36.9%, 48.9%, and 69.4%, respectively. Disposable hand-controlled electrosurgical electrodes also saw significant increases across all three metrics, with imports reaching USD 169 million—the highest among all medical device categories.
Tissue repair biomaterials (commonly known as dermal fillers) saw production, exports, and imports rise 7.9%, 1.6%, and 25.2%, respectively. MFDS linked this to aging demographics and growing demand for skin anti-aging treatments.
Export market diversification continued. Medical devices were exported to 203 countries, with the top four markets (US, China, Japan, Russia) accounting for 35.9% of total exports, down 2.9 percentage points from the previous year. Exports to Germany, India, Thailand, and France increased.
By country, exports to the US rose 5.4% to USD 800 million; Germany +8.6%, India +10.3%, Thailand +16.3%, and France +12.8%. Exports to China fell 25.8%.
The number of medical device manufacturers and importers grew 2.2% to 7,570, and employees increased 7.8% to 162,531, marking two consecutive years of growth.
MFDS stated it will support rapid market entry for innovative devices and strengthen industry competitiveness through global regulatory leadership and support.
Source: Read the original report | Published: May 28, 2026