In 2019, the South Korea Ministry of Food and Drug Safety (MFDS) introduced UDI requirements starting with the highest-risk class of medical devices. The database, known as Integrated Medical Device Information System (IMDIS) has regulatory requirements for UDI by device class and Track and Trace supply reporting. The ‘Understanding UDI Series’ highlights key concepts for issuing agencies, product data elements and regulations for marketing medical devices in South Korea.
