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...
The new article provides a brief overview of the regulatory approach towards software-based products intended to be marketed and used in Australia. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
The new article highlights the aspects related to the general approach to the changes related to software products and also describes the most important concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...
Periodic Safety Update Reports (PSURs) are critical documents for medical device and in vitro diagnostic product manufacturers. These reports are a key component of a manufacturer’s post-market surveillance and risk management program, providing ongoing...