South Korea has introduced a new system designed to significantly shorten the time it takes for innovative medical devices to reach hospitals — in some cases to as little as 80 days. The Ministry of Health and Welfare and the Ministry of Food and Drug Safety (MFDS) announced the “Market Immediate Entry Medical Technology” framework to accelerate patient access to new technologies.
Under the new system, innovative devices that pass MFDS-recognised clinical evaluation can enter the market immediately, without undergoing a separate New Medical Technology Assessment.
The New Medical Technology Assessment is intended to verify the safety and effectiveness of new technologies before they are introduced into clinical use. Although assessment deferral schemes had previously been introduced to support the medical device industry and enable faster access, complex procedures and lengthy reviews often delayed early adoption.
To address this, the two ministries created a pathway allowing medical technologies based on devices that have undergone internationally enhanced clinical evaluation during the MFDS approval stage to be used immediately, without an additional assessment. This required revisions to both the “Rules on New Medical Technology Evaluation” and the “Notice on Medical Device Approval, Notification, and Review.”
As a result, the market entry period for eligible technologies has been reduced from up to 490 days to a minimum of 80 days.
The MFDS and the Ministry of Health and Welfare identified 199 device categories eligible for immediate entry, including digital medical devices, in vitro diagnostics and medical robots.
We will streamline market entry procedures for new medical devices to revitalize the industry and support their early introduction.
Kwak Soon-heon, Health and Medical Policy Officer at the Ministry of Health and Welfare
Kwak added, “We will keep working with agencies to implement the system, remove unsafe technologies, and monitor non-covered service use to reduce patient burden.”
Lee Nam-hee, director-general at the Medical Device Safety Bureau at MFDS, said, “We expect these system improvements will ease company difficulties in entering the market with new technologies, such as AI-enabled medical devices. Patients will gain more treatment options and access to new technologies.”
Lee added, “While promoting faster entry, we must ensure patient safety. We will do so using enhanced clinical evaluation data during approval and certification.”
