SOuth KOrea
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application. 

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.



Interested in obtaining fast market approval for your medical device or IVD 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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