The Therapeutic Goods Administration of the Australian Department of Health released a document on 13-Sep-2013 entitled “Regulation of medical software and mobile medical ‘apps’.” This explains at a high level Australia’s approach to regulation of medical software. It indicates a risk based approach is taken and that all medical devices are expected to meet the Essential Principles for safety and performance and any above Class 1 also require Conformity Assessment certification.
The full guidance is at the link provided. TGA – Regulation of medical software and MMApps