NEWS
Clarifying and Strengthening the Regulation of Medical Device Software Including Artificial Intelligence (AI)
The regulator’s mid-2025 review acknowledges that the existing, technology-agnostic, risk-based framework remains fundamentally appropriate for SaMD and AI-enabled medical devices ...more
News
December 10, 2025•5 min read
AusBiotech 2025 International Conference
AusBiotech 2025 offered a valuable reflection point for the biotechnology sector, particularly regarding GMP and regulatory compliance. ...more
News ,GMP
December 01, 2025•3 min read
Temporary GMP Exemptions for Bacteriophage Therapies in Australia
The proposed temporary GMP exemption by the TGA for personalised bacteriophage therapy manufacture in Australia marks a significant regulatory development for the emerging phage‑therapy sector. ...more
News
November 02, 2025•6 min read
New Regulations to Strengthen Medical Device Patient Safety
The introduction of mandatory reporting requirements for medical device-related adverse events marks a significant step forward in enhancing patient safety in Australia. ...more
News
October 26, 2025•4 min read
Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025
Understanding the Therapeutic Goods Legislation Amendment Effective from 1 October 2025 ...more
Therapeutic Goods Administration ,News
October 13, 2025•3 min read
Common Mistakes That Slow Regulatory Approvals—And How to Avoid Them
For therapeutic goods manufacturers, biotechnology companies, and testing laboratories, navigating the regulatory landscape can be complex and challenging. ...more
News
October 08, 2025•5 min read
