medical - RegDesk

Sep 26, 2023

HSA Guidance on IVD Registration Submissions: Essential Principles and Device Description

The new article addresses aspects related to the way conformity to the applicable Essential Principles should be demonstrated and also outlines the key points to be considered when providing a general device description. Table of Contents The Health Sciences Authority...

HSA Guidance on IVD Registration Submissions: Introduction

Sep 22, 2023

Asia

HSA Guidance on IVD Registration Submissions: Introduction

The present article provides an overview of the most important aspects related to submissions for in vitro diagnostic medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...

FDA Guidance on Informed Consent: Compensation, Contacts and Voluntary Participation

Sep 21, 2023

United States

FDA Guidance on Informed Consent: Compensation, Contacts and Voluntary Participation

The new article highlights the aspects related to compensation for participation in a clinical investigation, contact details to be communicated by study participants, and also the voluntary nature of participation and subjects’ rights associated thereto. Table...

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...

FDA Revised Guidance on Off-the-Shelf Software: Applications

Sep 21, 2023

United States

FDA Revised Guidance on Off-the-Shelf Software: Applications

The new article highlights the aspects related to the marketing applications related to the products incorporating software submitted under the various legal frameworks. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...

RegDesk Regulatory Roundup

HSA Guidance on IVD Registration Submissions: Essential Principles and Device Description

HSA Guidance on IVD Registration Submissions: Introduction

FDA Guidance on Informed Consent: Compensation, Contacts and Voluntary Participation

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

FDA Revised Guidance on Off-the-Shelf Software: Applications

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