FDA
The new article describes in detail the general requirements by FDA for informed consent to be followed by study sponsors and other parties involved in clinical investigations. Table of Contents The United States Food and Drug Administration (USFDA), the US...
MHRA
The new article highlights the aspects related to conformity assessment of In- Vitro Diagnostic medical devices. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has...
MHRA
The new article addresses the aspects related to the conformity assessment procedures in vitro diagnostic medical devices should undergo in order to ensure their safety and proper performance. Table of Contents The Medicines and Healthcare Products Regulatory...
FDA
The new article highlights the aspects related to the language to be used for informed consent, and also to the description the authority expects the parties responsible for clinical investigations to provide to potential study participants. Table of Contents The Food...
Mexico
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...
Bahrain
The article provides an overview of the regulatory requirements for custom-made medical devices intended to be used in Bahrain and also describes in detail the documentation to be submitted by an interested party when applying for marketing approval. Table of Contents...
