Europe
The guidance addresses aspects related to the safety measures to be developed and introduced by the parties responsible for performance trials in order to ensure the safety of study participants while maintaining the accuracy and reliability of the study results....
Africa
The new article highlights the aspects related to the classification rules to be applied with respect to in vitro diagnostic medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA) has published a guidance document dedicated...
Europe
The new article describes in detail the approach to be applied with respect to notifications, databases, liability insurance, and other aspects related to performance studies involving in vitro diagnostic medical device Table of Contents The Swiss regulating authority...
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...
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...
