Samsung Makes Galaxy Watch Health Tracking Officially Certified
Samsung Electronics just crossed a regulatory milestone that most health apps never reach. The company’s Galaxy Watch 8 health features are now officially recognized as a digital medical and health support device by South Korea’s Ministry of Food and Drug Safety.
This matters because it’s not just another app update. It’s the first product registered under a new framework that launched in January 2025, designed specifically for AI-powered health tools that fall outside traditional medical device categories.
The clearance covers core Samsung Health functions: heart rate monitoring, blood oxygen tracking, and step counting. These aren’t new features, but they’re now backed by government vetting under the Digital Medical Products Act that took effect in early 2024.
The regulation aims to separate legitimate health tools from the noise. By creating a voluntary reporting system, regulators can publicly list certified products and weed out exaggerated claims before they reach consumers.
Samsung didn’t wait to be regulated. The company actively participated in shaping the new system and filed early. That’s strategic positioning in a market where credibility matters more as wearables shift from fitness trackers to genuine health monitors.
Galaxy Watch users already get continuous heart rate monitoring with alerts for irregularities. Blood oxygen readings now carry extra weight when they come with regulatory backing, especially for tracking respiratory changes during sleep.
The company is betting that regulatory approval will become table stakes in preventative health tech. For now, they’re ahead of competitors still figuring out compliance.
