Africa
The new article describes in detail the approach to be applied with respect to in vitro diagnostic medical devices, provides an overview of the classification principles, and highlights the key points to be considered in this respect. Table of Contents The South...
FDA
The new article highlights the aspects related to additional submission types that could be used in specific cases and also describes the approach to be applied when no relevant submission type is used. Table of Contents The Food and Drug Administration (FDA or the...
IMDRF
The new article highlights the aspects related to the support stage – a period when healthcare providers use a medical device while being fully supported by its manufacturer. Table Of Contents: The International Medical Device Regulations Forum (IMDRF), a...
FDA
The article provides an overview of the questions and answers document issued by the US regulating authority and highlights the key points related to Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in healthcare...
Europe
The new article highlights the aspects related to serious adverse events, how they should be documented and reported, and the annual reporting requirements and procedures. Table of Contents The Swiss regulating authority in healthcare products (Swissmedic) has...
