Guidance for Additional Considerations to Support Conformity Assessment of In Vitro Companion Diagnostic Medical Devices
Regulatory guidance supporting conformity assessment procedures for in vitro companion diagnostic medical devices. This provides additional considerations and requirements for the review and approval of IVD companion diagnostics.
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 ↗