Regulation of software based medical devices

Software-based medical devices are medical devices that incorporate software or are software. Software is becoming increasingly important in medical devices, and as a medical device in its own right. Many devices are now available to inform users, drive or replace clinical decisions, or directly provide therapy to an individual. This increase in the number and availability of these devices meant new Australian regulations were needed to ensure patient safety.

This document provides information on the regulation in Australia for software and apps which meet the legislated definition of a medical device according to section 41BD of the Therapeutic Goods Act 1989, unless otherwise excluded. It does not apply to mobile apps that are simply sources of information, or tools to manage a healthy lifestyle. This information will help manufacturers and sponsors understand how the TGA interprets requirements, and thus indicate how they can comply with the regulations.

Main sections:

· Baby movement apps

· Communication program

· Software as a Medical Device (SaMD)

· Regulation of Digital Therapeutics (DTx)

· International regulatory activities

· Risks of harm

· Artificial intelligence chat, text, and language