Are You Ready for a TGA Post-Market Review? Post-Market Surveillance (PMS) Obligations for Australian Sponsors
Inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG) is not the end of an Australian sponsor’s regulatory responsibilities. Once a medical dev
ISO 20417:2026 Has Been Published: What Medical Manufacturers Need to Know
The second edition of ISO 20417, Medical devices – Information to be supplied by the manufacturer, has now been published, replacing the 2021 edition. The updated standard includ
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
How Medical Devices Are Classified in Australia (and Why It Matters)
Medical device classification is one of the most foundational decisions in bringing a device to market. It determines what evidence you need, how your device is assessed, and the r
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
