Korean Medical Device Registration (MFDS & MDMS)

Medical Device Registration in South Korea

To market medical devices or in vitro diagnostic devices in South Korea, manufacturers must obtain approval or registration from the Ministry of Food and Drug Safety (MFDS).

All regulatory activities, including product registration and lifecycle management, are managed through the Medical Device Management System (MDMS), the official digital platform used by Korean authorities.

The MDMS Platform

The Medical Device Management System (MDMS) is the central database for:

• Device registration and approval
• Submission of technical documentation
• Manufacturer and importer registration
• Post-market updates and reporting

All applications and regulatory communications with MFDS are processed through MDMS.

Regulatory Pathways

Depending on device classification, different regulatory routes apply:

Class I Devices

• Notification-based process
• Simplified registration through MDMS

Class II Devices

• Certification by a notified certification body
• Submission through MDMS

Class III and IV Devices

• Full MFDS approval required
• Detailed technical documentation and review process

Key Requirements

To complete registration in Korea, manufacturers must ensure:

• Appointment of a Korea License Holder (KLH)
• Compliance with Korea Good Manufacturing Practice (KGMP)
• Preparation of technical documentation aligned with MFDS requirements
• Submission of all required data through MDMS

Our Services

ALTRION supports manufacturers throughout the entire Korean regulatory process, ensuring efficient and compliant interaction with MFDS and MDMS.

Regulatory Strategy

• Device classification and pathway definition
• Registration planning and timeline optimization

MDMS Submission

• Preparation and submission of registration dossiers
• Management of MDMS workflows and documentation

KGMP Compliance

• Support for KGMP certification
• Audit preparation and coordination

Regulatory Communication

• Liaison with MFDS authorities
• Management of queries and additional information requests

Post-Market Activities

• Updates, modifications, and renewals
• Incident reporting and compliance monitoring

Our Approach

We combine local regulatory expertise with international experience to provide a structured and reliable pathway into the Korean market.

By managing MDMS submissions and regulatory processes directly, we ensure transparency, efficiency, and full compliance throughout the entire product lifecycle.