MFDS Announces Operational Guidance on Digital Medical Device Labeling and Guidelines on Clinical Trials Using Digital Technologies

Since the Digital Medical Products Act was brought into effect on January 24, 2025, the Ministry of Food and Drug Safety (MFDS) has been sequentially preparing and releasing detailed guidelines applicable to digital medical devices. Most recently, MFDS announced an operational guidance on labeling for digital medical device software (SaMD), which includes matters that companies manufacturing or importing SaMD must review from a practical perspective, as well as guidelines on the collection of clinical trial data using devices incorporating digital technologies. For more details, please click ‘View more’ below.