MFDS Issues Practical Guidance on Using MDSAP Materials in Korea Device Inspection and GMP Pathways
MFDS has issued guidance on responding to MDSAP-related review scenarios for medical devices in Korea. For manufacturers and Korean import-license holders that already operate under MDSAP, the guidance is relevant to how audit reports and CAPA records may be used to support or simplify Korea-facing inspection and GMP processes.