Diagnostic support accounts for the largest share of Korea's digital medical device market, a survey showed. The industry cited expanded licensing support and securing specialized personnel as the key challenges for the sector's growth.
The Ministry of Food and Drug Safety announced the results of its "2025 Digital Medical Device Market Survey" on Wednesday, conducted on 382 domestic digital medical device companies for the first time since the enforcement of the Digital Medical Products Act. The survey was based on responses from 274 of the companies subject to the comprehensive survey.
The survey found that diagnostic support was the main service area for digital medical device companies, accounting for the highest share at 35.8 percent. This was followed by testing (26.6 percent), information provision and management (15.3 percent), and treatment (12.4 percent).
By targeted disease, cardiovascular disease was the most common at 42.3 percent, followed by rehabilitation (37.2 percent), cancer (29.6 percent), mental health (23.4 percent), and diabetes (19.3 percent). In particular, the diagnostic support field was found to be concentrated in cardiovascular disease (48.0 percent) and cancer (34.7 percent).
Young workers and research and development personnel formed the core of the industry's workforce. By age group, those in their 30s were the most numerous at 38.9 percent, followed by those in their 40s (27.7 percent) and those aged 29 or younger (18.3 percent). By job function, R&D personnel accounted for the highest share at 33.3 percent.
Meanwhile, labor shortages remained a persistent issue. Of the responding companies, 48.9 percent said they faced difficulties securing personnel. The main reasons cited were a shortage of specialized and skilled personnel (63.4 percent) and a shortage of personnel with relevant educational backgrounds (14.2 percent).
In overseas markets, exports and imports showed similar levels. Companies with export experience accounted for 21.5 percent, while those with import experience accounted for 21.9 percent. Southeast Asia was the largest export market at 64.4 percent, followed by North America (37.3 percent), Central and West Asia (32.2 percent), and Northern and Western Europe (32.2 percent).
In contrast, imports were concentrated in Northern and Western Europe (63.3 percent) and North America (60.0 percent), indicating a high dependence on technology from advanced countries. Japan was the most preferred country for future market entry at 35.6 percent.
The industry cited expanding medical device licensing support as the most urgent task to invigorate business. Of the responding companies, 85.4 percent said support related to medical device licensing was needed, with high demand also for support regarding regulatory standards for AI-applied products (62.4 percent) and new health technology assessment and insurance coverage (48.5 percent).
The Ministry of Food and Drug Safety is currently holding regional regulatory support briefings and providing education and consulting through regulatory support centers in fields such as data clinical trials and security. However, the industry continues to call for expanded guidance on licensing procedures and regulatory standards for AI products. This is interpreted as stemming from the industry's demand for information and expanded guidelines on the new regulatory framework since the Digital Medical Products Act took effect in January last year.
"We plan to use the results of this survey in establishing policies to foster the digital medical device industry and in shaping licensing and regulatory support policies," a ministry official said.
