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The regulatory authority in South Korea is the Ministry of Food and Drug Safety (MFDS).
South Korea classifies medical devices according to risk (Classes I, II, III, and IV).
The entire process takes approximately five to ten months, depending on the device and class. The company must also obtain GMP certification, a three to five month process that can be done in parallel.
Product Licenses do not expire and GMP certificates are valid for three years.
An authorized representative is required to register devices in South Korea.
Last updated on January 10, 2018.
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For more information on registration in South Korea, check out the following articles on our blog:
Country at a Glance: South Korea