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 provisions regarding…
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Updated TGA Essential Principles Checklist
The Therapeutic Goods Administration (TGA) has released an updated version of the Essential Principles (EP) checklist for medical devices and…
TGA Publishes List of AI-Enabled Medical Devices
On 4 September 2025, the Therapeutic Goods Administration (TGA) released a public list of medical devices…
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 devices.
Digital Scribes: TGA Guidance Overview
The Therapeutic Goods Administration (TGA) has published guidance on the regulation of digital scribes, also known…
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 to…
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…
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Global Medical Device Classification Frameworks and Regulations
Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
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