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
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
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
KD&A in Sydney
KD&A have established an office in Sydney to better assist in the development and support of clients in Eastern Australia.
KD&A Opens New Sydney Office in March 2014!
To assist in the development and support of clients in Eastern Australia KD&A is opening a new office in Sydney. We also have a new location for our Adelaide office. We look forwar
