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 device is supplied in Australia, sponsors have ongoing post-market obliga
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 includes several technical revisions that clarify and refine the requirement
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 (EU MDR) to the implementation of Australia’s Unique Device Ident
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 acceptable overseas evidence for medical device applications. The updat
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 once largely a sponsor-driven system is evolving into a more integrated
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 monitor and enforce compliance across the therapeutic goods sector over th
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 channels, wellness-style positioning, and software-driven technologies are d
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 regulatory requirements you must meet. Because of its impact across the
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 safety and performance requirements that all medical devices must sat
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 introduced by the TGA in an online presentation and accompanying mate
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 significant reforms took effect from 25 February 2021, introducing new cl
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 devices interact with patients and clinicians. But with innovation comes re
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 patient needs. Recognising this shift, the Therapeutic Goods Administ
What You Need to Know About Australia’s Unique Device Identification (UDI) System in 2025
Australia’s medical device regulatory landscape continues to evolve, and 2025 has brought significant updates to the Unique Device Identification (UDI) system that manufacturers, developers, and regulatory professionals need to understand. What
Understanding Requirements for Medical Devices Containing Medicinal, Microbial, Recombinant, or Animal Origin Substances
Recombinant, or Animal Origin Substances Recent regulatory updates for medical devices containing medicinal, microbial, recombinant, or animal origin substances took effect on 1 July 2024. These changes align Australia’s classification framewor
TGA Recall Reforms: A Closer Look at the PRAC
Earlier this month, we shared an update on Linkedin regarding the Therapeutic Goods Administration (TGA) recall reforms and the introduction of the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC). Given the significance of these
KD&A Can Help You From the Start – Medical Devices Steps to Market
Do you have a medical device and don’t know what to do? Medical devices include a wide range of products from bandages to heart valves and in most regions, the term medical device also includes in vitro diagnostic (IVD) devices. If you are lost in
New Regulatory Changes for Medical Devices Containing Medicinal Substances, Animal, Microbial, or Recombinant Materials
As of 1 July 2024, new regulatory requirements for medical devices containing medicinal substances, or materials derived from animal, microbial, or recombinant sources will take effect. The Therapeutic Goods Administration (TGA) has released draft gu
