Korea's medical device industry posted a trade surplus for the sixth straight year last year as growth in production and exports continued. The in vitro diagnostics segment, which had slumped after COVID-19 became endemic, showed signs of recovery, and dental implants and aesthetic medical devices appeared to drive growth.
The Ministery of Food and Drug Safety said on the 28th that an analysis of the "2025 medical device production, export, and import performance" showed last year's domestic medical device production totaled 12.3558 trillion won, up 8.1% from a year earlier.
Last year's exports rose 2.2% to $5.37 billion (7.6395 trillion won), while imports increased 9.3% to $5.04 billion (about 7.1606 trillion won). As a result, last year's medical device trade balance recorded a surplus of $330 million (about 478.9 billion won), marking a surplus for the sixth consecutive year since 2020.
Production and exports fell sharply in 2023 due to decreased demand for COVID-19 diagnostic devices, but posted gains for two straight years through 2024 and last year. The domestic medical device market size also increased 12.6% from a year earlier to 11.8769 trillion won, recovering to its 2022 level.
The in vitro diagnostic medical device segment, which had plunged after the end of the COVID-19 windfall, showed signs of recovery. Last year's in vitro diagnostic medical device production came to 997.2 billion won, holding at a similar level to the previous year, while exports rose 6.0% to $738 million.
In particular, production of reagents for genetic testing of high-risk infectious agents increased 22.6% to 327 billion won, and exports rose 20.2% to $169 million.
The Ministery of Food and Drug Safety attributed this to growing demand shifting away from COVID-19-related products toward polymerase chain reaction (PCR) products for diagnosing non-respiratory diseases such as gastrointestinal infections and human papillomavirus (HPV) infections.
By item, dental implant fixtures ranked first in production for the third straight year with 2.4429 trillion won. The growth rate in production was 12.2%. General ultrasound imaging diagnostic devices ranked second in production with 753.8 billion won.
In exports, general ultrasound imaging diagnostic devices increased 10.2% year over year to $529 million to rank first, followed by dental implant fixtures at $399 million.
Aesthetic medical devices also showed notable growth. Production of general electrosurgical units used for improving skin wrinkles and other purposes rose 36.9% to 180.4 billion won, while exports and imports increased 48.9% and 69.4%, respectively.
Disposable hand-controlled electrosurgical electrodes used together also saw production up 50.4%, exports up 82.0%, and imports up 57.3%. This item topped all medical device import categories last year, with $169 million imported.
Biomaterials for tissue restoration, commonly known as fillers, also saw increases across production (522.4 billion won), exports ($376 million), and imports ($77 million). The Ministery of Food and Drug Safety said the expansion of demand for skin aging care driven by an aging population had an impact.
Export market diversification also continued. Last year, Korean medical devices were exported to 203 countries including the United States, and the share accounted for by four countries—the United States, China, Japan, and Russia—fell 2.9 percentage points to 35.9% from 38.8% a year earlier.
Exports to the United States increased 5.4% to $800 million (about 1.205 trillion won), and exports to Japan also rose 5.1%, while exports to China fell 25.8% to $450 million (about 678 billion won). Exports to European and Asian countries such as Germany, India, Thailand, and France posted double-digit growth, continuing the trend of diversifying export markets.
The industry base for medical devices also expanded. The total number of medical device manufacturers and importers rose 2.2% year over year to 7,570 last year. There were 4,317 manufacturers and 3,253 importers. The number of employees increased 7.8% from a year earlier to 162,531, marking growth for the second straight year.
The Ministery of Food and Drug Safety said it will support the swift market entry of newly developed medical devices and strengthen global regulatory competitiveness to back the growth of the domestic medical device industry.