The following documents were published by the Russian agency Roszdravnadzor and are in PDF format.
Korean Regulators Waive Registration Requirements for Some Mobile Medical Devices
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The South Korean Ministry of Food and Drug Safety (MFDS) has announced steps to loosen medical device registration requirements (link in Korean) for some fitness-related mobile medical products—including Samsung’s line of Galaxy mobile and wearable products for leisure and fitness use.
According to current Korean medical device regulations, no distinctions are made between devices such as heart rate monitors used in medical or sports and leisure settings. Previously, industry participants had voiced concerns that the MFDS would apply South Korean medical device registration requirements broadly to smart phones and mobile applications that do not fall neatly into regulated medical device categories; now it appears as though the MFDA plans to address mobile medical app regulation in a way similar to that in the US.
Specifically, heart rate monitors and pulse rate monitors intended for leisure and fitness will be excluded from MFDS classification requirements. Regulators are accepting comments regarding these exemptions through April 7, 2014.
The MFDS move should reassure developers of mobile medical apps and devices that major market regulators will favor more nuanced and deliberative approaches to oversight of the rapidly evolving telehealth arena.