Samsung S5 not a medical device, bypasses Korean regulation

Smartphone maker escapes the need to gain government approval, after South Korea's Ministry of Food and Drug Safety confirms the Galaxy S5 will not be classified a medical device despite its in-built heart rate sensor.
Written by Eileen Yu, Senior Contributing Editor

Despite sporting a heart rate sensor, Samsung's upcoming Galaxy S5 smartphone will not be classified a medical device by the Korean government--a status the smartphone maker will no doubt be celebrating. 

The confirmation from South Korea's Ministry of Food and Drug Safety means Samsung will not be tied to regulations that could delay the launch of its flagship model, slated for launch next month, reported local news wire Yonhap Agency

The ministry said it would revise current laws to better distinguish between heart rate sensors used for leisure and medical purposes. "Although the Galaxy S5 is technically a medical device under the current law, it will be excluded from the category after the revision," an official from the ministry said in the report, adding that the amendment would take about 25 days to complete. It added that other countries including the U.S. and Japan had already implemented similar product classification. 

The Galaxy S5 smartphone will be equipped with a built-in heart rate sensor, which can be connected to smartwatches to monitor the user's heart rate. The inclusion, however, had led to concerns it could hamper the April 11 launch of the device should the smartphone be classified a medical device, hence, requiring tests and approval from the ministry before it can be sold commercially. Medical devices are defined as equipment used to diagnose, treat, or prevent diseases, according to the Yonhap report.

First announced at last month's Mobile World Congress in Barcelona, Spain, the S5 will sport a 5.1-inch high-definition 1080p display, Snapdragon 800 2.5GHz quad-core processor, and a 16-megapixel camera. Besides the heart rate monitor, the smartphone will also have a fingerprint scanner.

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