The regulatory authority in South Korea is the Ministry of Food and Drug Safety (MFDS). CLASSIFICATION SYSTEM:
South Korea classifies medical devices according to the EU model of risk-based classification (Classes I, IIa, IIb, III, and IV). TIMEFRAME:
The entire process takes approximately six months. The company must also obtain GMP certification, a two to three month process that can be done in parallel. LICENSE VALIDITY:
Licenses are valid for three years. AUTHORIZED REPRESENTATIVE:
An authorized representative is required to register devices in South Korea.
Last updated on January 22 2015.
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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