Korean regulator designated 29 products as innovative medical devices in 2024
The Ministry of Food and Drug Safety (MFDS) said it designated 29 products utilizing technologies, such as big data, artificial intelligence (AI), mobile applications, and virtual reality (VR), as innovative medical devices in 2024.
KBR(https://www.koreabiomed.com)Since the system’s implementation in 2020, the total number of designated products has reached 88, reflecting a growing interest in advanced medical technologies. Applications for designation have also surged, increasing from 79 in 2023 to 108 in 2024, marking a 137 percent rise.
In 2024, medical device software continued to dominate, accounting for 79 percent of the designated products, followed by mechanical devices (17 percent), and in vitro diagnostic medical devices (4 percent).
To facilitate the swift adoption of these innovations in clinical settings, the MFDS has implemented preferential and phased reviews for designated products. Since 2022, the agency has operated the “Innovative Medical Device Lifecycle Safety Management Technical Support Program,” offering tailored, step-by-step support from designation to commercialization and market entry.
“In 2025, we will actively support the rapid market entry of innovative medical devices incorporating advanced technologies by applying GMP priority reviews to expand treatment opportunities,â MFDS Medical Device Safety Bureau Director Lee Nam-hee said. âAt the same time, we will continue to expand the scope of support to ensure that the public can use innovative medical devices with confidence.”