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
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
Australian Medical Device Conformity Assessment Regulations updated by the TGA
In July 2021 the Therapeutic Goods Administration (TGA) published significant updates to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
Personal Protective Equipment (PPE) Regulation as a Medical Device by the TGA
Due to the COVID-19 pandemic, the demand for PPE has significantly increased. In response to the greater demand, the TGA has issued guidance on the regulation of face masks, gloves
Changes to the Australian Register of Therapeutic Good (ARTG) inclusion process for non-measuring, non-sterile Class I medical devices
The TGA has changed the inclusion process by which non-measuring, non-sterile Class I medical devices are included in the ARTG. The changes came into effect October 2020.
TGA’s Medical Device Regulatory Changing Landscape
In 2020, the TGA are implementing a range of changes to the medical device regulations due to a number of reasons; some of which include changes to the European device regulations
Importance of Data Integrity and Document Management
In recent years there has been increased emphasis on data integrity, as this is a critical factor for the manufacturer in measuring the quality of their product and their credibili
Tips for transitioning to ISO 13485:2016
As the March 2019 deadline for ISO 13485:2016 is fast approaching, now is the time to start actively planning for the transition. When planning for the transition, it is important
