Regulations on Unique Device Identification Management
Regulations governing the implementation and management of unique device identification (UDI) systems for medical devices. This establishes requirements for device identification and traceability throughout the supply chain.
Manufacturers and sponsors placing medical devices on the South Korea market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗