Navigating the Updates to TGA Guidance on Excluded Software and Essential Principle 13B
In July 2024, the Therapeutic Goods Administration (TGA) released significant updates to their guidance documents on Excluded Software and Essential Principle 13B. These updates ai
Updates to Medical Device Regulations
Various changes have been made to the regulation of numerous types of medical devices by the TGA, including software-based medical devices, prescription spectacle lenses, medical d
Extension applied for acceptance of ISO 13485 manufacturer’s evidence for Class 2 and Class 3 IVD medical devices
International Standard ISO 13485:2016 Medical devices – QMS – Requirements for regulatory purposes was issued by the International Organisation for Standardisation in 2016. The
Medical Device Software – Potential for Consistent Regulation in Asia
The Asian Harmonization Working Party (AHWP) has published a white paper on medical software for comment. The AHWP has developed the paper in conjunction with the EU and the US wit
