RegDesk Regulatory Roundup

MHRA Guidance on Future Regulations: Specific Aspects

Nov 19, 2024

Great Britain

MHRA Guidance on Future Regulations: Specific Aspects

The new article provides additional clarifications regarding the upcoming changes to the UK regulatory framework.

FDA Draft Q&A on Translation of GLP Study Reports: Overview

Dec 19, 2023

FDA

FDA Draft Q&A on Translation of GLP Study Reports: Overview

The new article provides an overview of the existing legal framework for the translation of GLP study reports

Sep 22, 2023

MHRA

MHRA Guidance on IVD Regulations: Overview

The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK...

COFEPRIS Guidance on Changes to Sanitary Registry: Specific Aspects

Sep 20, 2023

Mexico

COFEPRIS Guidance on Changes to Sanitary Registry: Specific Aspects

This article details the process of modifying existing registration entries for medical devices permitted for marketing and use in Mexico. Table of Contents Mexico’s medical device regulatory authority, COFEPRIS, has released guidance on changes to the sanitary...

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...