New packaging and labeling requirements on medical devices imported to South Korea that went into effect in January have been revised by the country’s Ministry of Food and Drug Safety (MFDS). The revised regulations clarify the type of medical devices subject to the requirements, provide guidance on labeling products used for testing and research and soften requirements for approval of an imported non-registered medical device for personal use. The requirements also specify the information applicants must provide when applying for exemption from the requirements. They mandate the provision of a disposal plan and expiration date for the device.
A separate set of revised guidelines regulates 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.