TGA Offers Guidance on Regulating Software as a Medical Device

Australia’s Therapeutic Goods Administration is reviewing how it regulates software as a medical device (SaMD) and has issued guidance on its latest thinking.

TGA’s regulatory scope does not include software that doesn’t meet the definition of a medical device, including mobile apps that only serve as sources of information or tools that help a patient maintain a healthy lifestyle, the agency said.

Examples of SaMD include software that makes a diagnosis using patient information, X-ray image processing software and smart phone apps that calculate a patient’s required insulin doses using their blood glucose levels.