Monday, March 17, 2014

Samsung's Galaxy S5 Not Medical Device: Health Agency

From Yonhap:

Samsung Electronics Co.'s newest smartphone Galaxy S5 will not be categorized as a healthcare instrument despite having a heart rate sensor, the medical ministry said Monday, freeing it from regulations that could have complicated its sales launch.
The Ministry of Food and Drug Safety said it plans to revise the current law to distinguish heart rate sensors used for leisure purposes from those serving 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. "It will take about 25 days for the amendment."

   The ministry added major countries such as the United States, Japan and Britain already follow similar categorization.

Samsung's Galaxy S5 smartphone is the first in the industry to come with a built-in heart rate sensor, which can also be connected to smartwatches to monitor one's heart rate such as during exercise.

The feature had sparked concerns over the release schedule of the Galaxy S5, as local law stipulates that medical devices, defined as equipment used to diagnose, treat or prevent diseases, must be approved by the ministry before being sold in the market.

http://english.yonhapnews.co.kr/business/2014/03/17/50/0501000000AEN20140317005000320F.html

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