RegDesk Regulatory Roundup -- Medical Device and Pharma

Sep 20, 2023

FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers: Non-Clinical Animal and Clinical Performance Testing

The new article covers regulatory matters related to non-clinical animal testing and alternatives thereto, as well as clinical performance testing and the approach to be applied when determining whether it is reasonably needed to collect additional data. Table of...

FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws and Washers: Modifications

Sep 20, 2023

FDA

FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws and Washers: Modifications

The new article addresses the aspects related to modifications to existing medical devices already placed on the market and allowed for use in the US. The document describes in detail various types of changes and explains the way their regulatory status should be...

Sep 20, 2023

MHRA

MHRA Guidance on Registration Reliant on Expiring CE Certificates: Specific Scenarios

The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...

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...

FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers: Computational Modeling and Engineering Analysis

Sep 19, 2023

FDA

FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers: Computational Modeling and Engineering Analysis

This article describes in detail the approach to be applied with respect to computational modeling and engineering analysis to be conducted in the course of non-clinical testing of the products in order to assess their materials and characteristics. Table of Contents...

Sep 19, 2023

MHRA

MHRA Guidance on Registration Reliant on Expiring CE Certificates: Extensions

This article addresses the aspects related to the extensions to the timelines introduced in order to allow marketing products before compliance with the new regulatory requirements will be achieved. Table of Contents The Medicines and Healthcare Products Regulatory...

RegDesk Regulatory Roundup

FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers: Non-Clinical Animal and Clinical Performance Testing

FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws and Washers: Modifications

MHRA Guidance on Registration Reliant on Expiring CE Certificates: Specific Scenarios

TGA Guidance on Active Medical Devices: Introduction

FDA Draft Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers: Computational Modeling and Engineering Analysis

MHRA Guidance on Registration Reliant on Expiring CE Certificates: Extensions

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