TGA Clarifies Exclusion for Digital Mental Health Software
The Australian Therapeutic Goods Administration (TGA) published guidance on 16 March 2026 clarifying when software products intended…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 1–9 of 16
New UK CE Certificate Rules for ARTG Inclusion Applications
The TGA has released the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025, introducing new…
Updated TGA Essential Principles Checklist
The Therapeutic Goods Administration (TGA) has released an updated version of the Essential Principles (EP) checklist for medical devices…
TGA Publishes List of AI-Enabled Medical Devices
On 4 September 2025, the Therapeutic Goods Administration (TGA) released a public list of medical…
TGA Focuses on AI and Software-Based Medical Devices
The Therapeutic Goods Administration (TGA) has published a new regulatory focus on artificial intelligence (AI) and other software-based medical…
Digital Scribes: TGA Guidance Overview
The Therapeutic Goods Administration (TGA) has published guidance on the regulation of digital scribes, also…
Medical Device Regulatory Frameworks: New Zealand vs. Australia
To better understand how the medical device frameworks of Australia and New Zealand function in practice, it is essential…
TGA PMS and Vigilance Requirements for Medical Devices
TGA PMS and Vigilance Requirements for Medical Devices.
ISO 13485 Medical Devices: Global Regulatory Compliance
ISO 13485:2016 standards play a fundamental role in global regulatory compliance for medical devices. Nearly 30 years after the initial…
Showing 1–9 of 16