South Korea Medical Device Registration & Certification
Important Notes
- MFDS Approval: All medical devices require approval or licensing from the Ministry of Food and Drug Safety (MFDS).
- Product Classification & Licensing Pathway: Medical devices are classified into I-IV under the Medical Device Act, corresponding to "Notification," "Conformity Review," or "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 medical device.
- 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.
- Pricing & Health Insurance Reimbursement: Some medical 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 Specific 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 for medical devices.
- NHI-Dominated Payment System: With near 100% coverage by the National Health Insurance, inclusion in the reimbursement list is critical for medical device success, but subject to global reference pricing and strict cost-effectiveness evaluation.
- High Emphasis on Local Clinical Data: Approval of high-risk medical devices strongly prefers local clinical trial data or performance evaluation involving Korean populations.
- Competitive Landscape of Innovation & Local Manufacturing: The government provides fast-track review and premium incentives for innovative medical devices, while a strong local medical device industry competes fiercely in established markets.
- Advanced Healthcare Infrastructure & High Adoption: South Korea has one of the world's most advanced healthcare IT infrastructures and high adoption rates of innovative medical technologies, with hospitals and clinics actively seeking premium diagnostic and therapeutic devices.
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. Supervisory body over Korea Food & Drug Administration (KFDA) medical device operations.
KFDA
Korea Food & Drug Administration (KFDA)
Technical agency under MFDS, responsible for medical device 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 medical device 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