Mar 18, 2014
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.
The Korean Ministry of Food and Drug Safety (MFDS) has exempted (link in Korean) all Class I low-risk medical devices from quality system requirements previously necessary to obtain market authorization in South Korea.
South Korea’s Ministry of Food and Drug Safety (MFDS) has made three significant amendments to the country’s Medical Devices Act that will affect some market registrants going forward.
First, MFDS has introduced Summary Technical Documentation (STED) requirements for Class IV medical device registrants. Registrants with Class I, II and III devices may voluntarily submit application materials in STED format. Mandatory STED submissions for Class IV device applicants will become effective in January 2014.