Korea’s Ministry of Food and Drug Safety (MFDS) revised its digital medical device labeling guidelines on June 10. The update follows industry difficulties after the Digital Medical Products Act took effect in January 2025. Key changes include a grace period permitting previous labeling through January 23, 2027, and flexible guidance on recording version numbers and manufacturing dates for software products. Software disclosure requirements were also clarified, as key information must be disclosed via websites, user interfaces, or subscriber emails. Additionally, AI-enabled devices must now disclose learning methods, training data, and predicted performance ranges.
The Indian government is contemplating a move that would enable hospitals to directly import approximately 80 varieties of advanced medical equipment. This suggestion originates from the Central Drugs Standard Control Organisation (CDSCO) and encompasses equipment like MRI machines, CT scanners, PET-CT systems, SPECT/Gamma cameras, mammography units, and advanced X-ray machines. The intention behind this step is to expedite the acquisition process and improve diagnostic facilities through a streamlined importation procedure. Healthcare experts say easier access to advanced equipment could also reduce patient waiting times. The initiative remains under review, with stakeholder feedback expected before any final policy decision is made.