Regulation on the Permission, Notification, Review, Etc. of Medical Devices
Comprehensive regulation governing the approval, notification, and review processes for medical devices in South Korea. This establishes the pathways and requirements for obtaining market authorization for medical devices.
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 ↗