Health Functional Food Registration in South Korea: Import, Sale and Manufacture

Common situations

Pick the question closest to your case: each one gives the conclusion first, then what changes it, the documents involved and the expected timeline.

1. We are an overseas supplement brand — how do we get our products registered for sale in South Korea?

   Short answer Your products enter Korea through a registered importer, which registers your overseas factory and declares each shipment; the products must qualify as health functional food (HFF, 건강기능식품) under Korean ingredient standards.

   • If you appoint a Korean importer The importer holds the imported food import and sales business registration (수입식품등 수입·판매업 영업등록) and files the overseas facility registration and import declarations.
   • If you set up a Korean company It registers as an import and sales business with premises that meet facility standards.
   • If an ingredient is not on the published list of the Ministry of Food and Drug Safety (MFDS, 식품의약품안전처) Individual recognition of the ingredient (개별인정형 원료) is needed before the product can be sold as health functional food.

   Documents

   Import and sales business registration, overseas facility registration, import declaration, Korean labelling, ingredient and manufacturing method data

   Timeline

   Import and sales business registration 3 days; shipment inspection 2 to 10 days depending on the type

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2. We are a Korean company planning to import health functional food — what do we register?

   Short answer Obtain imported food import and sales business registration from the regional MFDS office (지방식품의약품안전청) for your premises, then register each overseas factory and declare each shipment.

   • If you will also sell to consumers yourself Check whether a separate sales business report applies to your outlets.
   • If you only import as an agent for others A different business category (import declaration agency) may apply.

   Documents

   Business registration application, premises meeting facility standards, overseas facility registration, import declaration

   Timeline

   Business registration 3 days

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3. Can our overseas company act as the importer itself without a Korean entity?

   Short answer The import and sales registration requires business premises in Korea that meet facility standards, so in practice an overseas company without a Korean presence uses a registered Korean importer or sets up a Korean company.

   • If you open a Korean subsidiary or branch with premises It can register as an import and sales business.
   • If you have no Korean presence Work through a registered Korean importer.

   Documents

   Korean entity documents and premises, or an importer agreement

   Timeline

   Registration 3 days once premises and documents are ready

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4. Does our overseas factory need to be registered with MFDS before we export to Korea?

   Short answer Yes. The overseas manufacturing facility must be registered with MFDS before the first import declaration, either by the importer or by the facility operator.

   • If the facility is registered Registration lasts 2 years and can be extended before it expires.
   • If it is not registered MFDS can refuse to accept the import declaration.

   Documents

   Overseas facility registration application, proof the facility is licensed or registered in the exporting country

   Timeline

   Before the first import declaration; valid for 2 years

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5. Our supplement uses an ingredient that isn't in Korea's health functional food code — can we still sell it?

   Short answer Not as health functional food until MFDS recognizes the ingredient based on safety and functionality data.

   • If the ingredient is on MFDS's published list Use it within the published standards.
   • If it is not A manufacturer or registered importer applies for recognition with safety and functionality data.
   • If the ingredient is claimed to treat or prevent disease It cannot be recognized as a health functional food ingredient.

   Documents

   Ingredient recognition application, safety data, functionality data, specifications

   Timeline

   Recognition must be obtained before sale; in practice, plan for an extended review

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6. We want to sell supplements online to Korean customers — what do we file?

   Short answer Selling health functional food requires a sales business report to the city/county/district office (시장·군수·구청장) for each outlet, with hygiene training completed first.

   • If you sell products made or imported by others File an HFF general sales business (건강기능식품일반판매업) report.
   • If you sell your own brand made by a specialized HFF manufacturing business File an HFF distribution sales business (own-brand) (건강기능식품유통전문판매업) report with the contract manufacturing agreement.

   Documents

   Sales business report, training certificate, contract manufacturing agreement (HFF distribution sales business)

   Timeline

   Decision within 3 days; deemed accepted if no notice is given; training every year

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7. We want our own supplement brand made by a Korean manufacturer — what licence do we need?

   Short answer If a specialized HFF manufacturing business makes the product and you sell it under your brand, you file an HFF distribution sales business report rather than getting a manufacturing licence.

   • If you only commission production File the HFF distribution sales business report with the contract manufacturing agreement.
   • If you are a venture company commissioning production A venture HFF manufacturing business (건강기능식품벤처제조업) licence from the regional MFDS office is another route.

   Documents

   Sales business report, contract manufacturing agreement, training certificate

   Timeline

   Sales report decided within 3 days

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8. We plan to manufacture health functional food in Korea — what are the requirements?

   Short answer A manufacturing licence from the regional MFDS office is needed for each site, with a quality manager (품질관리인), facilities meeting the standards and HFF GMP (우수건강기능식품제조기준) compliance.

   • Once licensed File a product manufacturing report (품목제조신고) for each product with its manufacturing method and other documents; MFDS responds within 10 days, otherwise the report is deemed accepted.
   • If the applicant is a foreign national Documents are legalized by a Korean consulate or apostilled.

   Documents

   Licence application, product types and manufacturing method, facility layout and equipment list, quality manager appointment, standards documents

   Timeline

   Product manufacturing report: 10 days

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9. How long does import inspection take, and what if a shipment fails?

   Short answer It depends on the inspection type, from 2 days for document review to 10 days for laboratory testing; a failed shipment must be returned, redirected or destroyed.

   • If the shipment passes The import declaration certificate is issued and the goods can be distributed.
   • If it fails Within 1 year of notice, return or re-export it, convert it to approved feed, give it for non-food public use, or destroy it.

   Documents

   Import declaration, Korean labelling, inspection documents

   Timeline

   Document review 2 days, on-site 3 days, random sampling 5 days, laboratory testing 10 days

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10. Our product is a vitamin gummy — is that health functional food in Korea?

    Short answer Health functional food is food made with ingredients that have a useful function for the human body; the current definition has no dosage-form requirement, so gummies and drinks can qualify.

    • If it uses functional ingredients MFDS has published or individually recognized It can be sold as health functional food under the relevant licences.
    • If it does not It cannot be sold as health functional food.

    Documents

    Formula and ingredient list for classification

    Timeline

    Classification before any filing

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