Medical Device Regulations South Korea

Medical Device Classification in South Korea

Risk-based classification

In South Korea, medical devices are regulated under a risk-based classification system with four categories: Class 1, Class 2, Class 3, and Class 4, where the requirements for product registration increase with the level of risk. The classification ensures that the regulatory scrutiny is proportionate to the device's potential impact on patient safety.

Classification Overview

Class 1: Low-Risk Devices
Examples: Bandages and surgical instruments without measuring functions.
Requirements: Pre-market notification to the National Institute of Medical Device Safety Information (NIDS).
Exemptions: No technical file review or Quality Management System (QMS) certification is required.

Class 2: Low to Medium-Risk Devices
Examples: Thermometers and infusion pumps.
Requirements: Pre-market approval, including technical documentation review and a valid QMS certification.

Class 3: Medium to High-Risk Devices
Examples: Orthopedic implants and diagnostic imaging equipment.
Requirements: Pre-market approval with detailed technical documentation and QMS compliance.

Class 4: High-Risk Devices
Examples: Pacemakers and heart valves.
Requirements: The approval process must be stringent, involving in-depth technical documentation and strict QMS conformity.

QMS Requirements and KGMP Certification
South Korea mandates Korean Good Manufacturing Practices (KGMP) certification for Class 2, 3, and 4 device manufacturers. Unlike other regulatory systems, an ISO 13485 certificate alone cannot meet the QMS requirements. KGMP certification involves auditing the manufacturing process to ensure compliance with South Korea's specific standards.

The Ministry of Food and Drug Safety (MFDS) oversees this certification, and manufacturers must maintain compliance to market their products successfully in South Korea.

Registration Routes South Korea

Medical Device Regulations South Korea

South Korea offers two distinct registration pathways for Class II medical devices: certification or pre-market approval. The route choice depends on whether a substantially equivalent device already exists in the Korean market.

Certification Route
This pathway applies to devices with a substantially equivalent counterpart already available in South Korea.

• Submission Requirements: Manufacturers must prepare a submission with comparative data demonstrating equivalence to the existing device.
• Review Process:
  • Certification is conducted by the National Institute of Medical Device Safety Information (NIDS).
  • After certification, final approval is granted by the Ministry of Food and Drug Safety (MFDS).
• Advantages: This route is generally faster, relying on the equivalence assessment with a previously approved device.

Pre-Market Approval Route
Devices without a substantially equivalent counterpart in the Korean market must undergo this more detailed process.

• Submission Requirements: A complete technical file must be submitted, including extensive data on performance, safety, and efficacy.
• Review Process: The MFDS conducts an in-depth documentation review, ensuring the device meets all regulatory requirements.
• Challenges: This route typically takes longer due to the comprehensive evaluation process.

•  Korean Ministry of Food and Drug Safety (MFDS)
•  Standards of Medical Device Good Manufacturing Practices (English)
•  Medical Devices Act 
•  Enforcement Decree of the IVD Act