Food and drug safety ministry revises medical-device casebooks

The food and drug safety ministry said it revised two medical-device casebooks, adding frequently asked questions and answers arising in day-to-day work.

The ministry prepared the revisions with the Korea Medical Device Safety Information Institute. First issued in 2024, the casebooks now include questions and answers that commonly arise in actual administrative processing. The ministry said the additions would improve the guides' usefulness for the industry.

The ministry said, "We will continue to build a medical-device safety-management environment that helps resolve difficulties in registering integrated information and reporting supply records, and improves work efficiency."

The casebooks cover registration and management of medical-device integrated information and supply reporting and management.

The guidance says licensed, certified or notified devices need a model-specific UDI-DI registered only once, at their first shipment.

Supply reporting applies to grade 3 and 4 implantable medical devices and reimbursed therapeutic materials supplied to medical institutions. The supply-reporting guide tells users to delete existing data before submitting a report again when previously submitted records have not been removed.

Users can access the revised casebooks through the user-guide menu of the ministry's medical-device UDI tracking management system and get assistance through the medical-device integrated information center call center.