Australia’s medical device market regulator, the Therapeutic Goods Administration (TGA), has published guidance on its approach to medical software and mobile medical applications.

Based on the TGA guidance, it does not appear that the agency is planning any near-term requirements specifically targeting medical software or apps; any software or app product that meets the TGA’s definition of a medical device must go through the same registration and approval process as more conventional types of devices.

However, the TGA mentions its ongoing participation in an International Medical Device Regulators Forum (IMDRF) working group deliberating how best to regulate stand-alone medical software and apps either under existing frameworks or through new requirements. If IMDRF members determine that these products require their own market authorization process, the TGA will revise its own approach to medical software and mobile app registration in Australia.

Stewart Eisenhart