Medical Device Registration and Approval in South Korea

General country-specific regulatory information is provided on this page for medical device registration and approval in South Korea. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including South Korea, to expedite the preparation of your medical device or IVD registration application.

Medical device regulations and classification in South Korea

 REGULATORY AUTHORITY: The medical device 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.

For more information on Medical Device Registration in South Korea, check out the following articles on our blog!

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