South Korea MFDS Medical Device Registration

Regulatory Framework of the MFDS

The medical device market in South Korea is overseen by the Ministry of Food and Drug Safety (MFDS). The primary legal basis for this oversight is the Medical Device Act (MDA) and its associated Enforcement Decree of the Medical Device Act. This regulatory framework manages the entire lifecycle of products to ensure they meet national standards for safety and quality. Under the MDA, manufacturers must navigate a structured registration process, including product classification and a detailed review by the MFDS, to verify compliance before commercialization.

Risk Classification and Technical Requirements

South Korea utilizes a risk-based classification system, as defined in the Enforcement Decree of the MDA, which determines the complexity of the registration pathway. Devices are divided into four classes:

• Class I: Represents the lowest risk, typically requiring only a notification to the MFDS.
• Class II: Moderate-risk products that require more detailed technical documentation.
• Class III & IV: High-risk and implantable technologies that undergo the most rigorous scientific review by the MFDS.

For Class II, III, and IV devices, manufacturers must submit a technical dossier that proves the safety and effectiveness of the product. This documentation includes technical specifications and testing reports which are reviewed by the MFDS prior to granting a medical device license.

Requirements for Overseas Manufacturers

For manufacturers whose registered place of business is outside of South Korea, it is mandatory to appoint a legal entity based in South Korea to act as the holder. The holder serves as the primary liaison with the MFDS, managing registration applications, communications regarding technical queries, and legal importation. They are also responsible for ensuring that all product labeling and instructions for use (IFU) are provided in the Korean language and for reporting any adverse events to the MFDS to protect public health.

Market Access and Maintenance of Licenses

Achieving market access requires the successful completion of the MFDS review process and the issuance of a registration certificate. Once a license is granted, it remains valid unless significant regulatory changes or safety concerns prompt a review. The holder must ensure that any administrative updates are promptly filed to maintain uninterrupted market access. Furthermore, a vigilance system must be established to monitor device safety and coordinate corrective actions or recalls with the manufacturer when necessary.

Proregulations' South Korea MFDS Registration Services

Our standardized process facilitates efficient navigation of the requirements defined by the MDA and its Enforcement Decree:

• Holder representation and license management
• Product classification and regulatory strategy development
• Technical dossier preparation and review for Class II, III, and IV
• Korean labeling and IFU localization
• Post-market vigilance and incident reporting assistance
• Liaison with the MFDS and health authorities

If you are interested in our South Korea MFDS registration services and wish to secure your market position, please feel free to contact us.