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A new system allowing certain “immediate market entry” medical technologies to be used in clinics without a separate new health technology assessment is reshaping South Korea’s artificial intelligence medical device sector. The lower barrier is expected to expand the size and competitiveness of K-AI medical devices, but debate remains over safety verification and accountability.
Industry officials said 113 of the 199 device items covered by the immediate-entry system are digital medical devices that include AI-based standalone software. Companies have welcomed what they call an opening of the AI medical device market, expecting faster commercialization to spur research and development and attract outside investment.
Park Chang Min, president of the Korean Society of Medical Artificial Intelligence and a radiology professor at Seoul National University Hospital, said the move reflects urgency as competitors such as the United States and China move quickly. “It can improve access to innovative technology for patients and clinicians, and give breathing room to domestic medical AI companies facing financial strain,” he said.
A medical device industry official said it was “clearly positive” that shortened procedures improve conditions for new entrants. Another industry official said companies may face higher expectations: “As the review period shrinks, the standards regulators demand will rise. The change is both an opportunity and pressure.”
Clinicians and patient-safety advocates raised broader concerns. Jeon Jin Han, policy director at the Association of Doctors for Humanism, said AI has already been a major beneficiary of early-entry policies such as deferrals of new health technology assessments. “The key issue is that medical technologies that have not gone through the new health technology assessment are hard to view as sufficiently verified for safety and effectiveness,” he said, adding that approval by the Ministry of Food and Drug Safety does not itself mean clinical effectiveness has been proven.
The system is intended to introduce and use strong medical technologies earlier. Critics warn that skipping the new health technology assessment — which can take up to 250 days — and allowing market entry based only on ministry approval could lead to adverse outcomes such as misdiagnosis.
Some experts also called for separate standards for generative AI-based medical devices. In a report, the Korea Health Industry Development Institute said generative AI medical devices need new evaluation criteria that consider potential indications, and that a management system is essential to monitor adverse events in real time and update products continuously.
The government said it is putting procedural safeguards in place. Seong Hong Mo, director of the medical device policy division at the Ministry of Food and Drug Safety, said AI medical devices already undergo strict review of safety and effectiveness at the approval stage, and that companies and medical institutions are required to report adverse events.
Seong said a separate oversight system is also in place for AI model updates. Under the Digital Medical Products Act that took effect last year, he said, companies must seek approval again if key performance or intended use changes significantly.
Experts said the policy’s success will depend on tighter post-market controls. Park said a clear mechanism must work to remove technologies from the market if they fail to prove effectiveness in clinical use or if misuse or side effects are confirmed. “Speed and safety are separate issues,” he said, adding that lower entry barriers must be paired with strong post-market monitoring and a clear exit structure.
* This article has been translated by AI.
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