Medical devices exported to South Korea are subject to new packaging and labeling requirements under guidance issued by the Ministry of Food and Drug Safety that went into effect in January. The new regulations, in the pipeline for a year, had been expected. They clarify labeling requirements to mandate the inclusion of expiration dates, usage plans, and whether a device is intended solely for the purpose of conducting research. The regulations also expand the number and type of medical devices subject to regulation.
A separate set of guidelines is designed to regulate the supply in South Korea of scarce and urgently needed devices. They require manufacturers to submit surveys proving demand for their devices. In addition, manufacturers need to submit detailed plans for why a device is needed, explanations of the reasons for supplying such devices, and references to particular patients or healthcare institutions.