South Korea

Medical Device Market Size

• Market Value: In 2024, South Korea’s medical device market was valued at approximately USD 484.76 billion, with the diagnostic segment accounting for USD 219.29 billion.
• Growth Projections: The market is projected to grow at a CAGR of 10.62% from 2024 to 2032, reaching significant milestones in various segments, including homecare settings and portable devices.

Future Growth Potential

• Aging Population: South Korea’s rapidly aging population is increasing the demand for advanced medical devices, particularly in diagnostics and homecare.
• Technological Advancements: The country is investing heavily in smart medical devices, with the market expected to grow from USD 1.25 billion in 2024 to USD 2.54 billion by 2030, at a CAGR of 12.7%.
• Government Initiatives: The Ministry of Food and Drug Safety (MFDS) is streamlining regulatory processes to facilitate faster market entry for innovative devices.

Registration Process

1. Regulatory Authority: The Ministry of Food and Drug Safety (MFDS) oversees the regulation of medical devices in South Korea
2. Device Classification: Medical devices are classified into four categories based on risk:
• Class I: Low risk (e.g., forceps, stethoscopes)
• Class II: Low to moderate risk (e.g., syringes, infusion pumps)
• Class III: Moderate to high risk (e.g., anesthesia systems, ventilators)
3. Class IV: High risk (e.g., heart valves, coronary stents)
4. Registration Requirements:
• Class I Devices: Require a Pre-Market Notification.
5. Class II, III, and IV Devices: Require Pre-Market Approval, including submission of technical documentation and, in some cases, clinical data.
6. Quality Management System: Manufacturers must comply with the Korea Good Manufacturing Practice (KGMP) standards.
7. Local Representation: Foreign manufacturers must appoint a Korea License Holder (KLH) to manage the registration process and liaise with the MFDS.
8. Importation: Only licensed importers certified by an MFDS-authorized body can import medical devices into South Korea.
9. Other Information

• Language Requirements: All documentation and labeling must be in Korean.
• Post-Market Surveillance: Manufacturers are required to monitor device performance and report adverse events as part of post-market obligations.
• Regulatory Updates: The MFDS regularly updates its guidelines to accommodate emerging technologies, such as AI-based medical devices.