South Korea Strengthens Oversight of AI-Enabled Medical Devices with Updated MFDS Guidance

South Korea has taken another major step toward shaping the future of digital health regulation. In late November 2025, the Ministry of Food and Drug Safety (MFDS) released an updated guidance document providing clearer, more structured expectations for the development, approval, and lifecycle management of AI-enabled and software-based medical devices.

As artificial intelligence continues to transform diagnostics, treatment planning, and patient monitoring, regulatory authorities worldwide are adapting to ensure these technologies remain safe, effective, and accountable. MFDS’s latest update aligns South Korea with global harmonisation efforts while supporting technological advancement in a rapidly expanding sector.

A Framework Built for Modern AI and SaMD Innovation

The updated guidance strengthens the regulatory foundation for both standalone software (SaMD) and embedded AI functionalities. It introduces new clarity on several key areas necessary for responsible AI deployment in healthcare, including:

1. Algorithm Transparency and Explainability

MFDS emphasises the need for developers to clearly describe how algorithms make decisions, define model architecture, and disclose limitations. This is especially critical for high-risk clinical applications.

2. High-Quality Training Data and Validation

Manufacturers must demonstrate that training data is reliable, representative, and free from bias. Validation data must reflect real-world clinical scenarios to prove consistent performance across diverse patient populations.

3. Robust Performance Evaluation

The updated guidelines require detailed verification and clinical performance testing. This includes sensitivity analysis, error rate evaluation, and clearly justified performance metrics tailored to the device’s intended use.

4. Cybersecurity and Data Protection

To protect patient safety and data integrity, MFDS outlines strengthened cybersecurity expectations, covering secure data management, privacy safeguards, and protection against algorithmic manipulation.

5. Post-Market Monitoring Requirements

Manufacturers must maintain ongoing performance monitoring, including regular reporting, event tracking, and analysis of real-world outcomes. Adaptive AI models must have clearly documented change control plans.

6. Change Management for Learning AI Models

For devices capable of continuous or periodic learning, MFDS requires a structured change protocol. Manufacturers must define acceptable update ranges and criteria for when regulatory re-evaluation is necessary.

Why This Matters for MedTech Developers

These updates are designed to strike a balance between innovation and safety, ensuring that AI-enabled technologies can thrive while maintaining public trust. For organisations seeking market access in South Korea, the new requirements provide several strategic implications:

• Greater Regulatory Clarity: The guidance reduces ambiguity in AI evaluation, making expectations more predictable.

• Improved Global Alignment: MFDS is now more closely aligned with frameworks from IMDRF, FDA, and EMA, which supports smoother international submissions.

• Higher Evidence Expectations: Companies must prepare for more comprehensive data requirements, particularly for high-risk applications.

• Enhanced Post-Market Obligations: Lifecycle management is emphasised throughout, particularly for devices with adaptive or evolving algorithms.

  
  

These changes reinforce South Korea’s position as a leader in digital health regulation and one of Asia’s most forward-thinking MedTech markets.

A Step Forward for Digital Health Innovation

With the rapid acceleration of AI in healthcare, regulatory systems must evolve to maintain safety, performance reliability, and accountability. MFDS’s updated guidance is a crucial step toward achieving these goals, ensuring that AI-enabled medical devices entering the Korean market are supported by robust, scientific evidence and responsible lifecycle practices.

For developers, manufacturers, and authorised representatives, now is the right time to review compliance strategies, update documentation, and refine post-market monitoring systems to align with the new expectations.

South Korea’s strengthened regulatory oversight is not just a procedural update; it is a significant milestone for the region’s digital health ecosystem and a signal of continued commitment to global regulatory excellence.