April MedTech regulatory reform update: international recognition, IVDs and AI

Posted by: , Posted on: - Categories: Conferences and events, Improving Our Services, Med Tech Regulations, Medical Devices

Last time I wrote was just before we headed to Washington DC for the 25th Session of the International Medical Device Regulators Forum (IMDRF), hosted by the US Food and Drug Administration (FDA). The first two days were a workshop …

DSUR Submissions and Fees are Changing from 1 June 2024

Posted by: and , Posted on: - Categories: Clinical Trials

February 2025: We have updated some details in this blog post to reflect changes to the payment system and annual progress reports (APRs). The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the …