Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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[Press Release, April 21, 2020] The World’s First Blood Pressure Measurement Mobile App Approved As Medical Device
  • Registration Date 2020-06-17
  • Hit 2474
[Press Release, April 21, 2020 / unofficial translation] The World’s First Blood Pressure Measurement Mobile App Approved As Medical Device - Conveniently measure your blood pressure from your wrist with a smart watch and mobile app - □ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) approved the world’s first software medical device (Software as a Medical Device, SaMD) on April 20, which uses a “mobile app” to measure blood pressure. ○ This medical device, “Blood Pressure App” developed by “Samsung Electronics,” is a software that uses a smart wristwatch (mobile platform) without wearing cuff* on your arm to conveniently measure blood pressure and inform your systolic/diastolic blood pressures as well as heart rates. * When wearing on the arm, it expands and contracts to measure the systolic/diastolic blood pressures ○ Particularly, this “blood pressure app” fulfills all blood pressure and heart rate accuracy standards, which are the same medical device performance standards with the existing automatic electronic blood pressure monitors that are generally used. ※ Automatic electronic blood pressure monitor: Electronic blood pressure measuring device that measures the arterial pressure non-invasively by using an expanding cuff on the arm, wrist, or thigh ※ Automatic electronic blood pressure monitor performance standards: ?(Blood pressure accuracy) Average difference ±5 mmHg or less, with standard deviation of 8 mmHg or less ?(Heart rate accuracy) ± 5 % or less □ To accelerate the development of cutting-edge SaMD products, the MFDS held a conference this January and listened to mobile app companies’ opinion on Korean/foreign software development trends and requirements for regulatory improvements. ○ Reflecting the industry’s opinions, the MFDS revised the “medical-use mobile app safety management guidelines” to enable the mobile app to get an exclusive approval without any approval for devices/equipment utilized as mobile platforms such as smartphones or tablet PCs in February 2020. ○ For reference, a total of 35 “mobile app” medical devices have been approved, including software for medical image analysis equipment*. * Software for medical image analysis equipment (example): Software that sends medical images captured via CT, x-ray to a health care provider’s mobile device such as their smartphone and zooms in, zooms out, and views the images. □ In line with the 4th Industrial Revolution era, the MFDS expects the development of mobile platform-based SaMD products to be facilitated further, and ○ It committed to support the quick commercialization of medical devices combined with cutting-edge technology.
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