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<p>This study analyzed 1556 clinical investigation plan approvals granted by the Ministry of Food and Drug Safety (MFDS) in the Republic of Korea by integrating regulatory databases and comparing the clinical investigation characteristics of traditional and digital medical devices (2003–mid 2024). Indicators included clinical investigation purpose, device classification, number of participating institutions, design characteristics, annual approval trends, major product categories, and time required from plan approval to marketing authorization. According to the Korean MFDS four-class medical device classification system (Classes 1–4), digital medical devices, predominantly concentrated in Class 2 and 3 software, exhibited a high proportion of Pivotal clinical investigations (68%); traditional medical devices, distributed among high-risk Class 3 and 4 devices, had a relatively higher proportion of exploratory investigations. The number of plan approvals for digital medical devices surpassed that of traditional devices for the first time in 2023; cognitive therapy and diagnostic assistance software constituted the major product categories. The mean time from approval to marketing authorization was significantly shorter for digital medical devices than for traditional medical devices.</p>

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Landscape of regulatory clinical investigations status of traditional and digital medical devices in the Republic of Korea (2003–mid 2024)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月15日

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  • Eunyee Cho,
  • Jiwon Seo,
  • Eunji Jeon,
  • Chungkeun Lee,
  • Kwang Gi Kim

摘要

This study analyzed 1556 clinical investigation plan approvals granted by the Ministry of Food and Drug Safety (MFDS) in the Republic of Korea by integrating regulatory databases and comparing the clinical investigation characteristics of traditional and digital medical devices (2003–mid 2024). Indicators included clinical investigation purpose, device classification, number of participating institutions, design characteristics, annual approval trends, major product categories, and time required from plan approval to marketing authorization. According to the Korean MFDS four-class medical device classification system (Classes 1–4), digital medical devices, predominantly concentrated in Class 2 and 3 software, exhibited a high proportion of Pivotal clinical investigations (68%); traditional medical devices, distributed among high-risk Class 3 and 4 devices, had a relatively higher proportion of exploratory investigations. The number of plan approvals for digital medical devices surpassed that of traditional devices for the first time in 2023; cognitive therapy and diagnostic assistance software constituted the major product categories. The mean time from approval to marketing authorization was significantly shorter for digital medical devices than for traditional medical devices.