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Medical device and IVD manufacturers that want to sell their products in South Korea will have to follow the requirements of the Medical Devices Act, a set of regulations put forth by the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration). For more information on getting approval for the South Korean Market, download the chart.
With 50 million residents and high per capita spending on healthcare, South Korea is one of the largest Asian healthcare markets, roughly equal in
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