With the rapid growth of artificial intelligence in healthcare, South Korea has emerged as a leading market for AI-based medical devices (Software as a Medical Device – SaMD).

However, these devices must meet strict clinical and regulatory requirements set by the Ministry of Food and Drug Safety (MFDS), especially when it comes to clinical validation and performance evidence.

In this guide, we explain the clinical trial requirements, approval process, and compliance strategy for AI medical devices in South Korea in 2026.

What is an AI-Based Medical Device?

AI-based medical devices are software-driven products that use algorithms or machine learning to: Diagnose diseases Predict medical conditions Assist clinical decision-making Analyze medical imaging or patient data

These are regulated as Software as a Medical Device (SaMD) under MFDS.

Regulatory Framework for AI Devices in South Korea

South Korea has introduced advanced regulatory pathways under: MFDS medical device regulations Digital Medical Product frameworks (recent updates) AI-specific evaluation guidelines

These frameworks focus on: Algorithm transparency Clinical validation Data integrity Lifecycle monitoring

When is a Clinical Trial Required?

Clinical trials are typically required when: The device is Class II, III, or IV with significant risk There is no predicate device available AI algorithm introduces new diagnostic functionality Clinical evidence is insufficient

Clinical Trial Approval Process (Step-by-Step)

Step 1: Pre-Submission Strategy

Step 2: Clinical Trial Protocol Development

Include: Study objectives Patient population Inclusion/exclusion criteria Evaluation metrics (accuracy, sensitivity, specificity)

Step 3: Ethics Committee Approval (IRB)

Step 4: MFDS Clinical Trial Application

Submit: Clinical trial protocol Device technical documentation Risk management file Investigator details

Step 5: MFDS Review & Approval

MFDS evaluates: Safety and risk profile Scientific validity of study Data collection methods

Step 6: Conduct Clinical Trial

Data collection from real patients

Monitoring and reporting

Adverse event tracking

Step 7: Clinical Study Report Submission

👉 Used for final device approval

Clinical Data Requirements for AI Devices

AI-based devices require more advanced data validation compared to traditional devices.

Key Requirements: Large and diverse datasets Training vs validation dataset separation Performance metrics: Accuracy Sensitivity Specificity Real-world clinical evidence

Unique Challenges for AI-Based Clinical Trials

1. Algorithm Transparency - MFDS may require explanation of AI decision-making

2. Data Bias & Validation - Biased datasets can lead to rejection
3. Continuous Learning Systems - Adaptive AI requires lifecycle monitoring
4. Cybersecurity Risks - Protection of patient data is mandatory

Clinical Trial Timeline in South Korea

Common Mistakes in AI Clinical Trials

Best Practices for Faster Approval

Engage with MFDS early (pre-submission consultation)

How OMC Medical Can Help

OMC Medical provides specialized regulatory support for AI-based medical devices in South Korea, including:

✔ Clinical trial strategy & protocol development
✔ MFDS submission support
✔ Technical documentation preparation
✔ AI compliance and validation guidance
✔ End-to-end regulatory consulting

👉 We help AI innovators achieve faster approvals with reduced risk

Get Expert Support

Planning to launch your AI medical device in South Korea?

Contact OMC Medical today for expert regulatory and clinical trial support.