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Moon administration to ease medical device regulations to spur innovation

2018-07-20 0 Dailymotion

President Moon Jae-in went to a local hospital on Thursday... where he announced the first step in a series of efforts for innovative growth.<br />The president again called for extra efforts to remove excessive and unnecessary regulations, this time starting with the medical field.<br />Cha Sang-mi reports. <br /> The chair of the Korean Society of Type 1 Diabetes, who has a son with the disease, explained how she had to look abroad to order a device to check her little son's blood sugar without having to poke his finger to draw blood over ten times a day.<br /> Her efforts were praised by President Moon Jae-in who was on a visit Thursday to a university hospital for a event related to his policy of pursuing innovative growth.<br />President Moon said this is just one of many cases where regulations keeping devices off the market for too long have caused patients and their families to despair.<br /><br /> "When it comes to the people's safety and bioethics, we should definitely take a careful approach. But when devices are already certified, we need to significantly lower the regulatory barriers and reduce the time it takes to get them on the market."<br /> <br /> "The government regulates the medical device sector for the safety of the people. But the regulation process means bringing a new device from development to the market can take up to 5-hundred-20 days."<br /><br /> President Moon condemned the technical evaluation process as harder than actually inventing or developing a device. <br />He said he welcomes efforts to save lives and vowed to break with the sector's outdated practices and regulations.<br />He also promised to, first, allow high-tech medical devices to be launched quickly under a separate assessment procedure; second, to minimize the licensing process for already-certified invitro diagnostic devices by simply getting permission from the Ministry of Food and Drug Safety, which would cut the time it takes from over a year to less than 80 days.<br />Lastly, President Moon pledged to make the difficult licensing process easier by offering an integrated service for all three related agencies. <br />Cha Sang-mi, Arirang News. <br />

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