Nutrition Product Registration & Regulatory in South Korea

Nutrition Product Registration & Regulatory Services in South Korea

End-to-End strategic regulatory service provider for Nutrition industry in South Korea. We support product registration and regulatory submissions in South Korea for food, dietary supplements, and health supplements. Our team works closely with MFDS to meet local compliance requirements.

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Health & Dietary Supplement Registration – MFDS Korea

Artixio is a trusted and leading global regulatory service provider company. With our global experts team and integrated solutions, we help our clients to successfully launch their product by reducing the time to market entry. We provide end-to-end services for nutrition products in the South Korea including product branding and launching strategies, product registration in compliance with regulatory requirements of South Korea, and market strategy as well.

South Korea Food Product Registration & Regulatory Guidance

The regulatory agency of South Korea, Ministry of Food and Drug Safety (MFDS) established a Food Safety Management System to provide safer food.

In South Korea, the Standards and specifications for Health functional food, was established to set criteria for manufacturing processing, production, import, distribution and preservation of health functional food products.

As per the MFDS South Korea, Health functional foods are products manufactured and processed with functional ingredients or elements useful for human health. Here the term “Functional” means adjustment of nutrients in the human body structure or function, or those that bring useful health effects for e.g., in physiological reaction, etc.

The term “functional ingredient” means any ingredient with functionality used in manufacturing of health functional food such as raw materials from animal, plant or raw material originated from microorganisms; its extracts and purified substances; vitamins and minerals; or their synthetics or composites, etc;

Approval of functional ingredient for Health Functional Food

The approval criteria of functional ingredient is as follows:

Product Registration approval Process
For Food & Supplements in Korea

The approval procedure for functional ingredient with the MFDS, South Korea is as follows:

The applicant must submit application to Korea Food and Drug Administration (Korea FDA) to get the functional ingredient approved and notified in South Korea market.

In the step of notification of approval, the Commissioner of the FDA will issue the “Certificate of Functional Ingredient for Health Functional Food”, to the applicant when recognizing the ingredient.

Registration of foreign food facilities In south Korea

For foreign food facilities exporting their products to Korea, registration to MFDS is mandatory and MFDS on-site inspection is carried out to verify sanitation status of foreign food facilities and to certify eligible establishments as a ‘Good Foreign Food Facility’.

The registration as a foreign food facility to MFDS must be completed before import declaration.

Importers or business operators of foreign food facilities are subject to registration

Applicant must online application through the Imported Food Information Maru

Letter of consent for registration or an official document proving business registration (in English) is required for submission.

The processing period for application is 3 days.

Registration procedure takes place through following steps

South Korea Regulatory Support for Nutrition & Supplements

Stepwise guidance approval of a nutrition product in South Korea
Strategies for compliance with MFDS requirements
Support throughout product lifecycle
Product registration and notification requirements
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FAQs

What is the approval timeline for functional ingredient in South Korea?

For the approval of functional ingredient in South Korea, 120 days are required from the date of receiving the documents.

Is there a provision by FDA to modify the contents of the certificate of functional ingredient? If yes, what is the procedure for it?

A person who intends to modify the contents of the certificate must submit the “Application of modification on Certificate of Functional Ingredient for Health Functional Food” to the commissioner of the FDA. Then the commissioner of the FDA will determine whether he accepts the modification under the condition without changing ingredient after reviewing the validity of modification reasons.

What is the applicable fees for approval application of Functional Ingredient for Health Functional Food?

For approval application of Functional Ingredient for Health Functional Food, the applicable fees is 100,000 won.

What is the processing time for application of modification on Certificate of Functional Food Ingredient for Health Functional Food?

5 days processing period is required for application of modification on Certificate of Functional Food Ingredient for Health Functional Food.

Nutrition Product Registration & Regulatory Services in South Korea

Nutrition

Services We Offer

Solution by Countries

Our Industries

Health & Dietary Supplement Registration – MFDS Korea

South Korea Food Product Registration & Regulatory Guidance

Approval of functional ingredient for Health Functional Food

Product Registration approval Process
For Food & Supplements in Korea

Registration of foreign food facilities In south Korea

Registration procedure takes place through following steps

South Korea Regulatory Support for Nutrition & Supplements

Why Artixio?

FAQs

Regulatory Expertise Across
Multiple Countries

Industries we serve

Pharmaceuticals

Cosmetics

Nutrition

Medtech

Biologics

Veterinary

Blogs

CDSCO Medical Device Approval

Computer Software Assurance(CSA) In

In Vitro Diagnostics: Meaning,

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Nutrition Product Registration & Regulatory Services in South Korea

Nutrition

Services We Offer

Solution by Countries

Our Industries

Health & Dietary Supplement Registration – MFDS Korea

South Korea Food Product Registration & Regulatory Guidance

Approval of functional ingredient for Health Functional Food

Product Registration approval Process For Food & Supplements in Korea

Registration of foreign food facilities In south Korea

Registration procedure takes place through following steps

South Korea Regulatory Support for Nutrition & Supplements

Why Artixio?

FAQs

Regulatory Expertise Across Multiple Countries

Industries we serve

Pharmaceuticals

Cosmetics

Nutrition

Medtech

Biologics

Veterinary

Blogs

CDSCO Medical Device Approval

Computer Software Assurance(CSA) In

In Vitro Diagnostics: Meaning,

Request a Consultation

Product Registration approval Process
For Food & Supplements in Korea

Regulatory Expertise Across
Multiple Countries