Overview of South Korean Guidelines for Approval of Large Language or Multimodal Models as Medical Devices: Key Features and Areas for Improvement

Abstract

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea, similar to the United States Food and Drug Administration and the United Kingdom's Medicines and Healthcare products Regulatory Agency, issued specific regulatory guidelines on January 24, 2025, for approving generative artificial intelligence (AI) technologies as medical devices [1].Although these guidelines use the term 'generative AI,' they predominantly focus on the approval of AI software tools based on large language models (LLMs) and large multimodal models (LMMs) [2], the latter of which can process various types of input data, such as texts, images, videos, audio, and bio-signals.Unlike the broader guidelines for approving AI models as medical devices, specific regulatory guidelines for LLMs/LMMs have arguably not yet been proposed in other countries.

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