Australian Regulation of Medical Software and Apps

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

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