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FDAnews Device Daily Bulletin
Oct. 18, 2012 | Vol. 9 No. 205
Changes in South Korean Device Regulations Add New Hurdles
New South Korean requirements for medical devices introduced this year make the country’s already strict regulation of foreign devicemakers even more rigorous, an expert says. One of the requirements — notification no. 2011-82 — calls for a safety and efficacy report and more stringent review of any device that does not have an equivalent in the Korean market, Brian Gilburg, vice president of business development at Emergo Group, said in a recent webinar.
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