Enforcement Rule of the Act on In-Vitro Diagnostic Medical Devices
Enforcement rule establishing operational requirements for in vitro diagnostic medical devices under South Korean law. This specifies approval procedures, quality standards, and post-market surveillance requirements for IVD 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 ↗