Digital Medical and Health Support Devices in Korea: Regulatory Update
In accordance with the Digital Medical Products Act enacted in January 2025, the Ministry of Food and Drug Safety (MFDS) has officially introduced the Performance Certification System for digital medical or health support devices, effective January 24, 2026, and finalized the specific device categories under Notification No. 2026-4 . What Are Digital Medical or Health Support Devices? These refer to instruments, machines, apparatuses, software, or similar products employing digital technologies that are not classified as digital medical devices, but are used to support medical purposes or promote and maintain health. Such devices monitor, measure, collect, and analyze biometric signals, or record and analyze lifestyle habits to provide health management information (e.g., diet, exercise). Scope of Digital Medical or Health Support Devices: Heart (pulse) rate measurement using PPG (PhotoPlethysmoGram) sensors Oxygen saturation measurement using PPG sensors Body composition ...