Understanding Australia’s Consent to Supply Mechanism for Medical Devices
Over the past several years, Australia’s medical device regulatory framework has undergone significant change. From the transition to the European Medical Device Regulation (
TGA Now Accepting UK Conformity Assessed (UKCA) Certification as Comparable Overseas Evidence: What This Means for Medical Device Sponsors
The Australian Therapeutic Goods Administration (TGA) has updated its comparable overseas regulatory framework to formally recognise UKCA certification from UK Approved Bodies as a
From Voluntary to Mandatory: The Evolution of Post-Market Surveillance in Australia
Over the past 12–18 months, Australia has undergone a significant transformation in how Post-Market Surveillance (PMS) for medical devices is structured and regulated. What was o
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
Advertising Medical Devices in Australia: Why Regulatory Scrutiny Has Intensified in 2026
Recent regulatory communications from the Therapeutic Goods Administration (TGA) reinforce a sustained focus on advertising compliance for medical devices. Digital marketing channe
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
Understanding the TGA’s Proposed Changes to IVD Classification – What Could This Mean for Manufacturers?
In May 2025, the Therapeutic Goods Administration (TGA) outlined proposed changes to the way in vitro diagnostic (IVD) medical devices are classified in Australia. The proposal was
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
Understanding the TGA’s Reforms on Point-of-Care Medical Device Manufacturing
The landscape of medical device manufacturing is evolving rapidly, with technological advancements enabling healthcare facilities to produce devices on-site, tailored to individual
