Guiding Principles for Conducting Clinical Trials for Machine Learning-enabled Medical Devices
Guidance document establishing principles and requirements for conducting clinical trials on medical devices that incorporate machine learning technology. This addresses specific regulatory pathways for AI/ML-enabled medical devices.
Manufacturers and sponsors placing medical devices on the South Korea market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
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