Hong Kong – Korea’s Ministry of Food and Drug Safety (MFDS) is looking to establish an international common set of guidelines for AI medical devices after its election to the first Chair of Artificial Intelligence Medical Devices (AIMDs) at a meeting of the International Medical Device Regulators Forum (IMDRF).
Australia's Therapeutic Goods Administration (TGA) proposed classifying active implantable medical devices (AIMDs), their accessories and active devices for controlling, monitoring or influencing the performance of an active device and software as high-risk class III devices. However, the agency has rethought the notion of up-classifying all implant device accessories after blowback from industry.