Ministry of Food and Drug Safety (MFDS) - Medical Device Regulation in South Korea

1. Overview of MFDS

The Ministry of Food and Drug Safety (MFDS) is the central regulatory authority in South Korea. Its mission is to promote public health by ensuring the safety, efficacy, and quality of medical devices, pharmaceuticals, and food products.

2. Regulatory Framework

The medical device sector is governed by the Medical Device Act (MDA). All devices must adhere to strict requirements for registration, manufacturing, and distribution.

3. Classification System

Devices are categorized into four classes based on risk:

• Class I (Low Risk): Minimal potential for harm (e.g., stethoscopes, manual wheelchairs). Notification to NIDS is required.
• Class II (Moderate Risk): Low potential risk (e.g., MRI, pulse oximeters). Requires certification or approval.
• Class III (High Risk): Significant risk (e.g., respiratory apparatus, anesthesia systems). Requires MFDS approval.
• Class IV (Very High Risk): Greatest potential risk (e.g., pacemakers, stents). Requires intensive MFDS approval.

4. Market Entry Requirements

To sell a device in South Korea, manufacturers must:

1. Appoint a Korean License Holder (KLH): Mandatory for foreign entities.
2. Obtain KGMP Certification: Compliance with Korean Good Manufacturing Practices.
3. Product Registration: Submission of technical documentation and clinical data (for higher risk classes).

5. Post-Market Surveillance

MFDS monitors adverse events and tracks devices through the Unique Device Identification (UDI) system to ensure long-term safety.