TGA Archives

Sep 26, 2023

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Specific Aspects

The new article highlights the aspects related to Class IIb spinal implantable medical devices and also highlights some other points related to the recent changes to the applicable classification rules impacting the regulatory status of spinal implantable medical...

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Introduction

Sep 22, 2023

Australia

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Introduction

The article provides an overview of the new classification approach adopted in Australia with respect to implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian healthcare product regulatory authority, has...

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Class IIb to Class III

Sep 21, 2023

Australia

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Class IIb to Class III

The new article describes in detail the approach to be applied with respect to the changes to existing entries due to the new classification rules. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...

TGA Guidance on Active Medical Devices: Introduction

Sep 20, 2023

Australia

TGA Guidance on Active Medical Devices: Introduction

The new article provides a brief overview of the regulatory status of active medical devices by TGA, the regulatory agency of Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...

Aug 16, 2023

Australia and Oceania

TGA on requesting reconsideration

The article describes the approach to be applied when requesting that a regulatory decision be reconsidered. Table of Contents The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of healthcare products, has...

TGA on application audits (review and outcomes)

Aug 16, 2023

Australia and Oceania

TGA on application audits (review and outcomes)

The new article highlights aspects related to the application review process and regulatory decisions the authority will make based on its assessment. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...

RegDesk Regulatory Roundup

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Specific Aspects

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Introduction

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Class IIb to Class III

TGA Guidance on Active Medical Devices: Introduction

TGA on requesting reconsideration

TGA on application audits (review and outcomes)

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