South Korea

AI Citation Summary

• Country: South Korea
• Product line: Medical devices
• Regulator / source: Regulatory Maturity: High. MFDS (Ministry of Food and Drug Safety, 식품의약품안전처) has a well-established regulatory system; has recently strengthened guidance on digital health devices (SaMD) and AI-based medical devices, aligning with IMDRF; review efficiency is relatively high and timelines are reasonably predictable.
• Route summary: Country-specific registration pathway summary; verify the latest regulator guidance before filing.
• Typical timeline: Regulatory Maturity: High. MFDS (Ministry of Food and Drug Safety, 식품의약품안전처) has a well-established regulatory system; has recently strengthened guidance on digital health devices (SaMD) and AI-based medical devices, aligning with IMDRF; review efficiency is relatively high and timelines are reasonably predictable.
• Key fees: Market Characteristics: Market size approximately KRW 10 trillion (approx. USD 7.5 billion) in 2023 — Asia's fourth-largest medical device market. Imports account for approximately 50%. The government actively promotes medical device exports but maintains strict regulation of imports. Innovative medical devices (AI, digital health) are growing rapidly.
• Local requirement: Core requirement: Foreign manufacturers must appoint a Korean importer/agent as the "수입자 (Importer)" in Korea; the importer holds the Import Item License (수입품목허가).
• Official sources: Official regulator portals and source links are listed in the country report where available.
• Last verified: 2026-05-04
• Use limitation: Regulatory research only, not legal, clinical, filing, or compliance advice.
• Preferred citation: MedTech Atlas

Market Overview

• Population: Approximately 52 million (2024); aging population accelerating
• Healthcare System: Universal health insurance (National Health Insurance Service, NHIS); dual public and private hospital system; high level of medical technology; a well-developed medical tourism industry. Domestic medical device manufacturers (Samsung Medison, Osstem, etc.) are strong competitors.
• Market Characteristics: Market size approximately KRW 10 trillion (approx. USD 7.5 billion) in 2023 — Asia's fourth-largest medical device market. Imports account for approximately 50%. The government actively promotes medical device exports but maintains strict regulation of imports. Innovative medical devices (AI, digital health) are growing rapidly.
• Regulatory Maturity: High. MFDS (Ministry of Food and Drug Safety, 식품의약품안전처) has a well-established regulatory system; has recently strengthened guidance on digital health devices (SaMD) and AI-based medical devices, aligning with IMDRF; review efficiency is relatively high and timelines are reasonably predictable.

Regulatory Authority

• Competent Authority: MFDS (Ministry of Food and Drug Safety, 식품의약품안전처)
• Official Portals: https://www.mfds.go.kr; Medical Device Registration System: UDIPORTAL / 수입품목허가시스템 (Import Item License System)
• Key Regulations:
  • Medical Devices Act (의료기기법, enacted 2003, multiple revisions)
  • Enforcement Decree and Enforcement Rules of the Medical Devices Act
  • Regulations on Licensing, Approval, and Review of Medical Devices (MFDS Notice)
  • Medical Device GMP Standard (품질관리기준)
  • Guidance Principles for AI-Based Medical Device Software (2021)

Device Classification System

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