RegDesk Regulatory Roundup

Oct 25, 2023

MHRA

MHRA Guidance on Innovative Devices Access Pathway: Overview

The article provides an overview of the new regulatory framework introduced in the United Kingdom as a pilot project.

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...

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...

Jun 8, 2021

MHRA

MHRA Guidance on Registration of Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published guidance describing the registration process medical devices must go through before placing them on the market in Great Britain...

FDA Guidance on Patient-Reported Outcome Measures

Mar 16, 2021

FDA

FDA Guidance on Patient-Reported Outcome Measures

The Food and Drug Administration (FDA) has published a guidance document dedicated to the patient-reported outcome measures and the way they should be used in medical product development to support labeling claims. Together with the Patient Preference Information...