South Korea Fast-Tracks AI Medical Devices with New Act

388 AI medical devices approved to date MFDS strengthens global cooperation and regulatory framework

2025-08-20     Sodam Park reporter
Digital medical device image recreated with Perplexity AI / Photo by Reporter Seonjae Choi

The enforcement of the Digital Medical Products Act in January has rapidly expanded the entry of AI-based medical devices into the South Korean market. The Ministry of Food and Drug Safety (MFDS) is driving this growth by introducing timely guidelines that balance industry innovation with patient safety.

The Act was designed to systematize the approval and safety management of advanced digital technologies—including artificial intelligence (AI), robotics, and virtual/augmented reality (VR/AR)—with the twin aims of accelerating healthcare innovation and safeguarding public health.

At a recent briefing, Young-kyu Kang, Head of the Digital Health Regulatory Support Division at the National Institute of Food and Drug Safety Evaluation, highlighted the impact of the law:

“Since the Act’s implementation, we have updated multiple AI guidelines to foster an environment where industry and regulation grow together. The results are already visible in the data.”

Young-kyu Kang, Head of the Digital Health Regulatory Support Division at the National Institute of Food and Drug Safety Evaluation, speaking at a press briefing / Photo by MFDS press corps

Clinical trial activity mirrors this growth. Approved clinical trial plans for AI medical devices now total 225, rising from just three in 2017 to 59 in 2023, 56 in 2024, and 22 in the first half of 2025.

An MFDS official noted, “Since releasing the world’s first AI medical device guidelines in 2017, we have provided regulatory guidance tailored to industry needs, enabling steady growth.”

To sustain momentum, MFDS has revised four key guidelines covering:

  • Clinical trial design for AI-applied digital medical devices

  • Approval and review of digital therapeutics

  • Devices using virtual or convergent technologies

  • Medical device software approvals

Beyond the South Korean policy, the MFDS has strengthened international cooperation. In December 2024, it co-published AI medical device trial guidelines with Singapore. In January 2025, through the International Medical Device Regulators Forum (IMDRF), it introduced the Good Machine Learning Practice (GMLP) framework, setting global standards for data independence, clinical representativeness, and risk monitoring.

Collaboration with other ministries is also expanding. Of the 25 projects under the Ministry of Science and ICT’s Dr. Answer 2.0 program, 20 have already received MFDS approval or trial authorization. Additional joint efforts with the Ministry of Health and Welfare and the Ministry of Trade, Industry and Energy aim to support R&D and provide regulatory consulting for digital therapeutics. MFDS is also working with the Korea Internet & Security Agency (KISA) to strengthen cybersecurity through vulnerability assessments and workforce training.

Looking ahead, MFDS will host a Digital Medical Device Approval and Review Seminar on August 27 at COEX in Seoul. The event will introduce new systems, explain revised guidelines, and collect feedback from industry stakeholders on regulatory challenges.