Korea License Holder (KLH) Services

MFDS medical device registration strategy

Medical devices placed on the South Korean market are subject to MFDS regulatory requirements. ALTRION helps manufacturers define an appropriate MFDS medical device registration strategy, taking into account device classification, intended purpose, technology and risk profile. This strategic phase helps identify the most efficient market access pathway and supports better preparation before submission activities begin.

Korean medical device classification assessment

Classification is one of the first steps in the Korean regulatory process. ALTRION supports Korean medical device classification assessment for Class I, II, III and IV medical devices, helping manufacturers understand how the device category affects documentation, registration requirements, testing activities and regulatory timelines. A correct classification helps reduce uncertainty and supports a more coherent submission strategy.

Technical documentation review and gap analysis

Technical documentation must be reviewed before entering the Korean registration process. ALTRION supports technical documentation review and gap analysis, helping manufacturers identify missing, incomplete or inconsistent information. This activity improves submission readiness and helps align the available regulatory file with the expectations of the Korean framework.

Korean labeling and IFU requirements

Medical devices commercialized in South Korea may require Korean language labeling and Instructions for Use. ALTRION supports manufacturers with Korean labeling and IFU requirements, helping verify that product information is aligned with local expectations and consistent with the device’s intended use, classification and regulatory documentation. This step is especially important for avoiding inconsistencies between technical documentation, user-facing materials and registration data.

Local testing and certification activities

Depending on device type, classification and technology, local testing or certification activities may be required. ALTRION supports the coordination of local testing and certification activities, helping manufacturers understand which requirements may apply and how they fit into the broader MFDS registration pathway. This support helps companies manage practical regulatory steps more efficiently during Korean market access projects.

KGMP-related regulatory pathways

Quality system documentation and KGMP-related obligations may be part of the Korean medical device registration process. ALTRION assists manufacturers with KGMP-related regulatory pathways, supporting the evaluation of applicable quality and documentation requirements. This service is particularly relevant for manufacturers that need to align Korean regulatory activities with existing international quality systems and compliance processes.

Support for software medical devices and digital health products

ALTRION also supports software medical devices and digital health products within Korean market access projects. These products may require specific attention to classification, technical documentation, intended purpose, software-related evidence and local regulatory expectations. ALTRION helps manufacturers assess the correct pathway and prepare the relevant documentation for the Korean regulatory environment.

Change notifications, renewals and amendments

Regulatory compliance in South Korea does not end with the initial registration. ALTRION supports the management of change notifications, renewals and amendments, helping manufacturers maintain compliance when product data, documentation, labeling, technical information or commercial arrangements change. This ongoing support helps ensure that Korean registrations remain aligned with the current status of the device.

Post-market surveillance and regulatory maintenance

After market entry, manufacturers must continue to manage post-market obligations and regulatory maintenance. ALTRION supports post-market surveillance activities and ongoing regulatory maintenance, helping companies monitor compliance, manage updates and maintain a clear regulatory position in South Korea. This life-cycle approach supports long-term market continuity and better control of regulatory responsibilities.

Coordination with Korean importers and distributors

Access to the Korean market often requires coordination with local importers, distributors and business partners. ALTRION supports communication and regulatory coordination with Korean importers and distributors, helping manufacturers keep commercial activities aligned with regulatory requirements. This support is useful for companies entering South Korea for the first time as well as for companies seeking to optimize existing Korean registrations and regulatory processes.

Regulatory project management for multi-country strategies

South Korea is frequently considered a strategic entry point for broader Asia-Pacific medical device expansion. ALTRION supports regulatory project management for multi-country market access strategies, helping manufacturers align Korean regulatory activities with international commercialization objectives involving the European Union, Switzerland, the United Kingdom, Middle East markets, ASEAN countries, Latin America and United States FDA projects.