Feb 2, 2023

TGA Guidance on Reclassification of Medical Devices in Direct Contact with the Heart, CCS, and CNS

The article provides an overview of the new classification rules for certain medical devices recently introduced in Australia. Table Of Contents: The guidance is intended to provide medical device manufacturers and other parties involved in manufacturing medical...

TGA Guidance on Reclassification of AIMD for Therapy with a Diagnostic Function

Jan 27, 2023

Australia and Oceania

TGA Guidance on Reclassification of AIMD for Therapy with a Diagnostic Function

The article provides an overview of the new classification rules to be applied. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a set of guidance documents dedicated...

TGA Guidance on AIMD Reclassification: Notification Process

Jan 27, 2023

Australia and Oceania

TGA Guidance on AIMD Reclassification: Notification Process

The new article describes in detail the approach to be applied by the parties responsible for medical devices when notifying the authority about the products subject to reclassification they are going to supply. Table of Contents The Therapeutic Goods Administration...

TGA Guidance on Reclassification of Active Implantable Medical Devices: Overview

Jan 27, 2023

Australia and Oceania

TGA Guidance on Reclassification of Active Implantable Medical Devices: Overview

The new article provides an overview of the recent changes to the classification rules for active implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has...

FDA Guidance on Post-Approval Studies: Reports Format and Content

Nov 30, 2022

Australia and Oceania

FDA Guidance on Post-Approval Studies: Reports Format and Content

The new article provides additional details regarding the applicable regulatory requirements for the content and format of interim and final post-approval study reports. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...

FDA Guidance on Clinical Outcome Studies: Specific Aspects

Nov 30, 2022

Australia and Oceania

FDA Guidance on Clinical Outcome Studies: Specific Aspects

The new article highlights certain specific aspects related to clinical outcome studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...

Our Regulatory Blog

Never miss a thing! The latest regulatory news and updates are always on our feed.

TGA Guidance on Reclassification of Medical Devices in Direct Contact with the Heart, CCS, and CNS

TGA Guidance on Reclassification of AIMD for Therapy with a Diagnostic Function

TGA Guidance on AIMD Reclassification: Notification Process

TGA Guidance on Reclassification of Active Implantable Medical Devices: Overview

FDA Guidance on Post-Approval Studies: Reports Format and Content

FDA Guidance on Clinical Outcome Studies: Specific Aspects

Take The First Step Towards Medical Devices Registrations

Categories

Categories

Tags