RegDesk Regulatory Roundup

Oct 13, 2023

FDA Guidance on Physiologic Closed-Loop Control Technology: Overview

The article highlights the key points related to the regulatory status of the products in question and describes the approach to be followed. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...

FDA Guidance on Antimicrobial Susceptibility Test System Devices: Specific Aspects

Oct 12, 2023

FDA

FDA Guidance on Antimicrobial Susceptibility Test System Devices: Specific Aspects

The article addresses the aspects related to the existing legal framework associated with AST system devices and highlights the key points to be considered. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...

FDA Guidance on Antimicrobial Susceptibility Test System Devices: Overview

Oct 12, 2023

FDA

FDA Guidance on Antimicrobial Susceptibility Test System Devices: Overview

The article provides an overview of the regulatory requirements set forth under the existing framework and highlights the key points associated thereto. Table of Contents The FDA, the US healthcare product regulatory authority, has released a guidance document...

CE Marking Guide for Medical Devices in the European Union

Oct 12, 2023

Africa

CE Marking Guide for Medical Devices in the European Union

This article highlights what CE marking is, how to obtain it, and the steps to follow to comply with EU regulations. Table of Contents Medical devices manufacturers willing to market products in the European Union (EU), must comply with the regulations established...

Overview of Medical Device Regulations in 2023

Oct 12, 2023

Asia

Overview of Medical Device Regulations in 2023

This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...