Medical Device Regulation in South Korea
South Korea's Ministry of Food and Drug Safety (MFDS) regulates medical devices under the Medical Devices Act. The four-class risk-based system requires notification, certification, or approval depending on risk. Korea has actively adopted IMDRF harmonization and has bilateral recognition discussions with major regulators.
Device Classification
Class 1 (lowest risk): notification to MFDS regional office. Class 2 (low-moderate risk): certification by Accredited Certification Institutions (ACIs). Class 3 (moderate-high risk): MFDS approval with technical review. Class 4 (highest risk, life-sustaining): MFDS approval with strictest evidence requirements including clinical data.
Official classification guidance →Standards & Key Principles
Applicable Standards
Key Principles
- Risk-based classification with notification, certification, or approval pathways
- GMP compliance mandatory for manufacturing and import
- Korean Authorized Representative (연락책임자) required for foreign manufacturers
- Korean-language labeling mandatory
- IMDRF harmonized clinical evaluation principles adopted
- Re-examination period for novel Class 3/4 devices
Pre-Market Requirements
Self-declaration notification to MFDS regional office. Declaration of conformity with applicable standards required.
Certification by Accredited Certification Institutions (ACIs) against applicable standards with GMP compliance.
Full technical dossier review by MFDS including clinical data, risk management, GMP inspection. Class 4 requires clinical investigation data.
Foreign manufacturers must appoint a Korean representative (연락책임자) to handle submissions and post-market obligations.
Post-Market Requirements
Novel Class 3/4 devices subject to post-approval re-examination. MAH must collect and submit safety/effectiveness data.
Serious adverse events reported to MFDS within 15 days (deaths/serious injuries) or 30 days (other events).
Ongoing post-market surveillance required. Recalls reported to MFDS; MFDS may mandate recalls for safety issues.
International Recognition & Reliance
FDA marketing authorization data accepted as supporting evidence for MFDS Class 3/4 approval applications.
CE marking documentation accepted as supporting evidence; bilateral discussions ongoing under IMDRF.