RegDesk Regulatory Roundup

Nov 29, 2023

Czech Regulation on Advertising Medical Devices: Specific Aspects

The article describes in detail the aspects related to the responsibilities of the parties involved in the distribution process.

Latvian New Rules on Clinical Trials: Overview

Oct 20, 2023

EU MDR/IVDR

Latvian New Rules on Clinical Trials: Overview

The article provides an overview of the new regulation and highlights the key points associated thereto.

Oct 12, 2023

Canada

Health Canada Guidance on Medical Device Application Types: IVDDs

The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices. Table of Contents Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device...

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...

Streamlining Medical Device Development: Investigational Device Exemptions and 21 CFR 812

Oct 12, 2023

CDRH

Streamlining Medical Device Development: Investigational Device Exemptions and 21 CFR 812

This article highlights the key elements of 21 CFR 812, Investigational Device Exemptions and their impact on the medical device industry. Table of Contents The FDA oversees the regulation of medical devices in the United States to ensure their safety and...