Ministry of Food and Drug Safety (MFDS), South Korea

The Ministry of Food and Drug Safety (MFDS) is South Korea's national authority for medical devices, medicines, food, and other regulated products. MFDS sets the medical device framework, grants higher-risk approvals, oversees quality and post-market controls, and works with designated bodies on defined review and certification functions. Manufacturers entering South Korea usually need a Korean license holder or importer.

Is MFDS the same as KFDA?

KFDA is the former English acronym for the Korea Food and Drug Administration. The authority was reorganized and renamed the Ministry of Food and Drug Safety in 2013, so MFDS is the correct current name. Legacy certificates, articles, and search queries may still use KFDA.

How are medical devices classified in South Korea?

South Korea uses Classes I, II, III, and IV, progressing from low to high risk. Class and product type determine whether notification, certification, or approval is required and which organization handles the review. A device's intended use, mode of action, invasiveness, duration, and novelty influence classification and the applicable product code.

What are notification, certification, and approval?

Lower-risk products can use notification or certification routes, while higher-risk or specified devices require MFDS approval. The responsible body and technical-review steps depend on classification and device category. The dossier may include device description, intended use, specifications, testing, risk management, clinical or performance evidence, quality documentation, and Korean labeling.

What is Korea GMP (KGMP)?

Medical device manufacturers must satisfy Korea Good Manufacturing Practice requirements when applicable. KGMP assessment is connected to the manufacturing site and device group and may involve document review and inspection. Product authorization and KGMP planning should run together because a mismatch in manufacturer, site, or scope can delay commercialization.

Does a foreign manufacturer need a local license holder?

A manufacturer outside Korea normally relies on a qualified Korean importer or license holder for submission and local regulatory responsibilities. The local party supports authority communications, importation, changes, renewals, vigilance, and recalls. Agreements should address ownership and transfer of authorization records and ongoing access to technical evidence.

How do I find official MFDS rules?

Use the MFDS English website and its medical device regulations library. When there is a discrepancy, verify requirements in the current Korean source text. MFDS lists +82-43-719-1564 for English-language assistance.

Related South Korea regulatory topics

See our South Korea medical device registration overview for the complete market-access pathway.