South Korea will not regulate Samsung's Galaxy S5 as a medical device

By Aditi Pai
06:27 am

GalaxyS5South Korea’s health regulatory agency, the Ministry of Food and Drug Safety (MFDS), announced that Samsung does not need to clear the Galaxy S5, which includes a heart rate sensor, as a medical device, according to a report from Engadget.

The ministry will also adjust the regulatory framework in South Korea to accommodate fitness devices, because the ministry currently regulates any device that measure heart rate.

As South Korean officials expected a few weeks ago when they first announced they would review the device, the testing procedure for the Galaxy S5 didn't take long.

At the beginning of the year, Samsung received FDA 510(k) clearance for its S Health app in the US. The clearance was categorized as a cardiology signal transmitter, which MobiHealthNews suggested might mean the clearance will allow S Health to integrate data from other connected medical devices.

Samsung’s S Health app originally launched for Galaxy S III users in the UK in the summer of 2012, but didn't come to the US until the launch of the Galaxy S4. Although the S Health app in the UK connected to different medical devices including Lifescan’s OneTouch UltraMini/UltraEasy Blood Glucose Meter and Omron’s blood pressure monitors, when it arrived in the US, it did not.

Since Samsung received FDA clearance for the S Health app, Glooko has hinted that its cable, which connects glucometers to smartphones, might be a potential connected device for the S Health app.


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