South Korea MFDS Regulatory Requirements for Medical Devices and IVDs

Navigating South Korea’s Medical Device Regulatory Process

South Korea’s robust medical device market is a prime opportunity for foreign manufacturers, particularly manufacturers of high-end devices. That being said, complying with the regulatory process will require some legwork. Korea has its own quality management system requirements and does not currently offer an equivalency registration pathway for existing market approvals. Manufacturers need to establish their device’s classification and equivalency according to Korean rules, ensure technical documentation formatting, and satisfy translation requirements for regulatory submissions.

Regulatory authority

Medical devices sold or distributed in Korea are regulated by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & Drug Administration (KFDA). MFDS enforces regulatory requirements according to the Korean Medical Devices Act (MDA) and the Enforcement Decree of the IVD Act.

Device classification

Medical devices and IVDs registered in Korea are classified into four tiers of increasing risk (Class I, II, III, and IV). Classification rules are closely based on the Global Harmonization Task Force (GHTF) classification system. Class II, III, and IV devices also need to identify a predicate device registered with MFDS. Regulatory requirements for your device will be determined by its classification and equivalency status.

Registration process

Class I devices in Korea must be notified to the Medical Device Information & Technology Assistance Center (MDITAC), with some exceptions for specific device types. Notification submission requirements include technical documentation in Korean, but are exempt from test reporting and KGMP certification. MDITAC reviews certifications for most Class I and II devices; MFDS reviews all Class III and IV submissions. Class II, III, and IV devices must submit full technical documentation in Summary Technical Documentation (STED) format in Korean, test reports, and KGMP certification. Without a predicate device, Class II-IV device submission may require clinical data and additional Clinical Data Review (CDR). Labeling and instructions for use must also be submitted in Korean.

Quality management system (QMS) requirements

South Korea outlines its own QMS requirements under Korean Good Manufacturing Practice (KGMP). Certification to KGMP is required for Class II, III, and IV devices and must be renewed every three years. ISO 13485 certificates are not accepted in lieu of KGMP certification.

In-country representation

Foreign manufacturers must appoint a Korea License Holder (KLH) to represent their company and devices to the MFDS. Your KLH holds your device registration and appears on the device labeling. They must also be a licensed importer and will purchase and import your devices to Korea, among other ongoing regulatory and quality compliance activities.

Expert Support for MFDS Registration & Market Entry in Korea

Considering MFDS registration for your medical device or IVD? Our team of experts can help you strategize and coordinate market entry in Korea. Contact us to learn more about Korean registration.