TGA Compliance Principles 2026–2027: What the Update Means for Industry
Recent Regulatory Update In January 2026, the Therapeutic Goods Administration (TGA) released its Compliance Principles for 2026–2027, outlining how the regulator intends to moni
Australia’s Essential Principles are changing: what Manufacturers and Software as a Medical Device (SaMD) Developers need to know
Australia’s medical device landscape is continuing to evolve, and one of the most significant developments on the horizon involves the Essential Principles (EPs) – the core
Australia’s SaMD Classification Changes: A Guide for Innovators
Australia’s Therapeutic Goods Administration (TGA) has been progressively reforming its medical device regulations, with software-based devices (SaMD) a major focus. The most sig
Keeping up with AI: Australia’s Next Chapter in Medical Device Regulation
Artificial intelligence isn’t just a buzzword in healthcare anymore — it’s already here, powering diagnostics, guiding treatment decisions, and transforming how medical devic
Navigating the Updates to TGA Guidance on Excluded Software and Essential Principle 13B
In July 2024, the Therapeutic Goods Administration (TGA) released significant updates to their guidance documents on Excluded Software and Essential Principle 13B. These updates ai
