Getting MFDS compliance wrong leads to a customs block or a recall. Covers cosmetics notification vs. functional cosmetics registration, Health Functional Food licensing vs. general food import, and the filing path for overseas brands.
Why MFDS matters
The Ministry of Food and Drug Safety (MFDS) oversees cosmetics, food, Health Functional Food, medical devices, and more. For these categories, Korean customs checks MFDS notification/licensing status at the border. Without the paperwork, clearance is refused outright.
A particular trap: products sold abroad as a general health food are frequently classified in Korea as Health Functional Food — a regime regulated closer to pharmaceuticals — so this needs careful checking.
Requirements by category
| Category | Regulatory type | Procedure | Timeline |
|---|---|---|---|
| General cosmetics | Notification | Responsible distributor registration + item notification | 2–4 weeks |
| Functional cosmetics (whitening, anti-wrinkle, sunscreen) | Review | Functional cosmetics review or report | 1–6 months |
| General food | Notification | Import declaration + inspection | Handled at customs clearance |
| Health Functional Food | Licensing / recognition | Functional ingredient recognition + item notification | 3–12+ months |
| Medical devices | License / certification / notification | Varies by grade | 3–12+ months |
Cosmetics in practice
For an overseas brand to sell cosmetics in Korea, a responsible cosmetics distributor must be designated first. That role must be held by a Korean entity.
Under KONIVO's Plan B structure, KONIVO can act as the responsible distributor on your behalf. Under Plan C/D, your own entity registers as the responsible distributor directly.
Labeling
A Korean-language label is mandatory for both cosmetics and food. Rather than changing the original label, it's standard practice to attach a supplementary Korean label (a sticker).
Required items: product name, net content, country of manufacture, manufacturer (or responsible distributor), full ingredient list (cosmetics), expiration date, precautions, and more. A missing item gets the shipment sent back at customs.
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