South Korea Product Registration & Certification
Important Notes
- MFDS Approval: All pharmaceuticals, medical devices, cosmetics, and Health Functional Foods require approval, licensing, or notification from the Ministry of Food and Drug Safety.
- Product Classification & Licensing Pathway: Medical devices are classified into I-IV under the Medical Device Act, corresponding to "Notification," "Conformity Review," or "Approval." Drugs require new drug or generic drug approval.
- Local License Holder: Foreign manufacturers must appoint a local Korean company (importer or subsidiary) as the "License Holder" to submit applications and assume all legal responsibilities for the product.
- Technical Documentation & Local Testing: Korean technical documentation is required. Class II+ devices usually require local testing (e.g., electrical safety, EMC) in MFDS-accredited Korean labs. Drugs must comply with the Korean Pharmacopoeia (KP).
- Pricing & Health Insurance Reimbursement: Drugs and some devices must apply to the National Health Insurance Service for inclusion in the reimbursement list ("Positive List"), undergoing rigorous health economic evaluation and price negotiation.
- Labeling & Advertising Language: All labels, instructions, and advertising materials must be in Korean, with accurate information and claims strictly matching MFDS approvals.
South Korea Requirements
- Highly Digitalized & Efficient Regulation: MFDS processes are highly transparent, digitalized, and time-bound, known for efficiency and predictability, but with strict and detailed technical requirements.
- NHI-Dominated Payment System: With near 100% coverage by the National Health Insurance, inclusion in the reimbursement list is critical for success, but subject to global reference pricing and strict cost-effectiveness evaluation.
- High Emphasis on Local Clinical Data: Approval of new drugs and high-risk devices strongly prefers local clinical trial data or pharmacokinetic studies involving Korean populations.
- Competitive Landscape of Innovation & Generics: The government provides fast-track review and premium incentives for innovative products, while a strong local generic drug and device industry competes fiercely in established markets.
- Consumer Enthusiasm for "K-Beauty" & Health Functional Foods: The cosmetics and Health Functional Food markets are vast and mature, with consumers seeking premium ingredients, technological innovation, and brand narratives, but highly sensitive to claim authenticity.
Medical Devices Registration
Regulatory Requirements
- Medical Device License
- Risk-based classification (Class I, II, III, IV)
- Complete Korean technical documentation
- Korean Good Manufacturing Practice Certification (KGMP)
- Korean labeling and instructions for use
- Compliance with Korean Medical Device Act
- Certificate of Free Sale
- CE Certificate of Conformity or FDA Approval
- Clinical Evaluation Report (Class III, IV devices)
- Performance verification data
- Test reports from accredited Korean laboratories
Main Process
- Product classification determination
- Technical documentation preparation and translation
- KGMP certification acquisition
- MFDS license application submission
- Korean licensed agent appointment
- Technical documentation assessment
- Product sample testing
- License certificate acquisition
Registration Timeline
10-26 months
Official Fees
₩8,000,000 - ₩80,000,000 (including application, evaluation, testing and license fees)
Service Fees
$22,000 - $65,000
Regulatory System Overview
MFDS
Ministry of Food and Drug Safety (MFDS)
Primary regulatory authority in South Korea, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals, cosmetics and health functional foods. Supervisory body over Korea Food & Drug Administration (KFDA).
KFDA
Korea Food & Drug Administration (KFDA)
Technical agency under MFDS, responsible for specific technical reviews, on-site inspections, laboratory testing and regulatory enforcement
NIFDS
National Institute of Food and Drug Safety Evaluation (NIFDS)
Research institute under MFDS, responsible for food and drug safety evaluation, standard development and scientific research, providing technical support for regulatory decisions
Medical Devices Registration Process
Product Classification
Determine risk classification according to Korean medical device regulations (Class I, II, III, IV)
Technical Documentation
Prepare complete Korean technical documentation including specifications, test reports, clinical data
KGMP Certification
Obtain Korean Good Manufacturing Practice certification
Licensed Agent Appointment
Appoint Korean licensed agent located in South Korea
MFDS License Application
Submit complete medical device license application to Ministry of Food and Drug Safety
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Notification
- Complete Product Information File
- Product Safety Assessment Report
- Compliance with Korean Cosmetics Act
- Korean product labeling
- Good Manufacturing Practice certificate
- Product stability test reports
- Microbiological testing reports
- Ingredient safety data
- Efficacy proof for functional cosmetics (if applicable)
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Product information file preparation
- Cosmetic notification submission
- Label compliance review
- Functional assessment (if applicable)
- Market access completion
Registration Timeline
4-8 months
Official Fees
₩800,000 - ₩5,000,000 (including notification and annual renewal fees)
Service Fees
$7,000 - $18,000
Regulatory System Overview
MFDS
Ministry of Food and Drug Safety (MFDS)
Primary regulatory authority in South Korea, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals, cosmetics and health functional foods. Supervisory body over Korea Food & Drug Administration (KFDA).
KFDA
Korea Food & Drug Administration (KFDA)
Technical agency under MFDS, responsible for specific technical reviews, on-site inspections, laboratory testing and regulatory enforcement
NIFDS
National Institute of Food and Drug Safety Evaluation (NIFDS)
Research institute under MFDS, responsible for food and drug safety evaluation, standard development and scientific research, providing technical support for regulatory decisions
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Korean permitted substances list and restrictions
Safety Assessment
Complete cosmetic safety assessment report by qualified safety assessor
Product Information File
Prepare complete product information file in Korean
MFDS Notification
Submit product information through MFDS Cosmetic Notification System
Functional Assessment
Functional cosmetics require additional efficacy documentation
Health Functional Foods Registration
Regulatory Requirements
- Health Functional Food Certification
- Functional ingredient certification
- Scientific justification for efficacy claims
- Compliance with Korean Health Functional Food Act
- Korean labeling and instructions
- Good Manufacturing Practice certificate
- Ingredient analysis reports
- Stability study data
- Clinical study data (if applicable)
- Functional assessment report
Main Process
- Product classification determination
- Functional assessment completion
- Technical documentation preparation
- Certification application submission
- Label compliance review
- MFDS technical evaluation
- Certification approval acquisition
Registration Timeline
7-14 months
Official Fees
₩3,000,000 - ₩15,000,000 (including application, evaluation and certification fees)
Service Fees
$14,000 - $38,000
Regulatory System Overview
MFDS
Ministry of Food and Drug Safety (MFDS)
Primary regulatory authority in South Korea, fully responsible for registration approval, quality supervision and market surveillance of medical devices, pharmaceuticals, cosmetics and health functional foods. Supervisory body over Korea Food & Drug Administration (KFDA).
KFDA
Korea Food & Drug Administration (KFDA)
Technical agency under MFDS, responsible for specific technical reviews, on-site inspections, laboratory testing and regulatory enforcement
NIFDS
National Institute of Food and Drug Safety Evaluation (NIFDS)
Research institute under MFDS, responsible for food and drug safety evaluation, standard development and scientific research, providing technical support for regulatory decisions
Health Functional Foods Registration Process
Product Classification
Determine product falls under general food or health functional food category
Functional Assessment
Prepare scientific evidence and research data for functional ingredients
Technical Documentation
Prepare ingredient analysis, safety evidence, efficacy claims in Korean
MFDS Certification
Submit health functional food certification application to MFDS
Efficacy Claim Review
Ensure efficacy claims comply with Korean authorized list and scientific requirements