Apple Watch’s New Sleep Apnea Notification Feature Approved in South Korea
South Korea’s Ministry of Food and Drug Safety (MFDS) has announced the approval status of medical products for August 2025. Last month, a total of 118 medical products received approval, comprising 33 pharmaceuticals, 6 quasi-drugs, and 79 medical devices. This represents 95% of the average monthly approvals from the previous year (124 products) and aligns with the monthly average for the first half of this year (117 products). Notably, the “Sleep Apnea Notification Feature (SANF)”—a portable respiratory analysis software—was approved in the digital medical device sector. SANF analyzes data collected from Apple Watch (Series 9 and later, Ultra 2 and later) to provide notifications for potential sleep apnea. GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties include KC EMC , KC Safety , KC Energy Efficiency , KC Automotive Components , KCsEx (ATEX, IECEx) , or MFDS (Korean Medic...