SOuth KOrea
REGULATORY AUTHORITY: The regulatory authority in South Korea is the Ministry of Food and Drug Safety (MFDS). 

CLASSIFICATION SYSTEM: South Korea classifies medical devices according to risk (Classes I, II, III, and IV).

TIMEFRAME: 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.

LICENSE VALIDITY: Product Licenses do not expire and GMP certificates are valid for three years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required to register devices in South Korea.

Last updated on January 10, 2018.



ARE YOU INTERESTED IN REGISTRATION IN SOUTH KOREA? REQUEST A FREE QUOTE>​

For​ more information on registration in South Korea, check out the following articles on our blog:
Country at a Glance: South Korea
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