Regulatory Affairs Consulting Services in South Korea

Efficient regulatory affairs solutions in South Korea for product approvals and seamless market entry. Local regulatory support for approvals, compliance, and lifecycle management in South Korea for life sciences industries.

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Regulatory Authorities in South Korea

Authority	Scope
Ministry of Food and Drug Safety (MFDS)	Central regulatory body responsible for the oversight of food, pharmaceuticals, medical devices, cosmetics, and related products in South Korea.
National Institute of Food and Drug Safety Evaluation (NIFDS)	An affiliate of the MFDS, NIFDS conducts scientific evaluations and research to support regulatory decisions, particularly in the assessment of pharmaceuticals and biologics.
Medical Device Information & Technology Assistance Center (MDITAC)	MDITAC assists in the certification and approval processes for medical devices, especially those classified as Class I and II, by reviewing technical documents and ensuring compliance with regulatory standards.

Regulatory Affairs Process In South Korea

South Korea follows a structured and category-specific yet commonly aligned regulatory framework under the supervision of the Ministry of Food and Drug Safety (MFDS). While the process varies by category type, the general approval pathway typically includes the following key steps:

Step 1 - Product Classification

Before submission, the applicant must identify the correct product category (e.g., drug, device, cosmetic) and classification (e.g., Class I–IV for medical devices, general vs. functional for cosmetics) to determine the documentation required.

Step 2 - Pre-market authorization application

Submit the comprehensive dossier containing:

Safety and efficacy data (clinical or non-clinical, as applicable)
Manufacturing process details
Quality control measures
Risk management and labeling information
GMP or KGMP compliance documentation

Step 3 - Good Manufacturing Practice (GMP) Compliance

Manufacturers must comply with Korean Good Manufacturing Practice (KGMP) or equivalent standards. This includes on-site inspections and documentation audits, especially for Class II–IV medical devices, biologics, and pharmaceuticals.

Step 4 - Technical Review and Evaluation

The MFDS or designated reviewing bodies (e.g., NIFDS for drugs, MDITAC for devices) assess the submitted documents including the validation of clinical performance, technical safety, product labeling, and manufacturing standards.

Step 5 - Product Approval

If the application meets all regulatory criteria, the MFDS issues one of the following depending on product type:

Product Approval Certificate (pharmaceuticals, biologics)
Device Certification or Approval (medical devices)
Functional Cosmetic Approval
Health Functional Food Certification
Veterinary Product License

Step 6 - Post-Market Obligations

Once approved, the company must undergo:

Different Types of Drug Approvals Process in South Korea

❖ New Drug Approval (NDA) or Biological License Application (BLA): New Drug Approval (NDA) or Biological License Application (BLA) is mandatory for all the new drugs that have never been sold in South Korea.

❖ Generic Drug Approval: General Drug Approval is a simple process for registration of generic drugs (drugs that are already approved with brand name).

❖ Biosimilar Drug Approval: Biosimilar Drug Approval is the process required for authorizing drugs similar to already approved brand name biological products.

❖ Conditional Approval: It is required for drugs that address urgent medical needs, such as treatments for rare diseases or pandemics. These may receive expedited review with post-marketing surveillance requirements.

Why Artixio

Are you looking for regulatory affairs company in South Korea?

Artixio supports a smooth, end-to-end registration process for pharmaceuticals, medical devices, cosmetics, nutrition, biologics, and veterinary products. Our highly experienced consultants bring deep knowledge of MFDS requirements and tailor regulatory affairs strategies that ensure compliance, enable faster market entry, and support long-term product success.

FAQs

Which documents are required to register a product in South Korea?

Technical documents with detailed information on product design, manufacturing processes, clinical data evidence demonstrating safety and efficacy, proof of compliance with KGMP standards, labeling information translated in Korean, as required.

What are the major compliance risks in the South Korean regulatory landscape?

Major risks include incomplete documentation, discrepancies between Korean and English submissions, inadequate risk management plans, and delays in PMS data reporting. Therefore, regular audits and local language compliance checks are important.

Are there any special regulatory pathways for innovative products or orphan drugs?

Yes, MFDS offers accelerated approval pathways for innovative therapies, orphan drugs, and pandemic-related products. These pathways may reduce review timelines, but require rigorous clinical and safety data upfront.

How frequently do post-approval changes need to be reported to MFDS?

All post-approval changes including administrative, qualitative, or manufacturing related changes must be reported according to MFDS change management guidelines. Some changes require prior approval, while others need only notification.