The article provides an overview of the existing regulatory framework for software-based medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in healthcare products, has published guidelines on the...
The new document describes in detail the aspects related to the existing types of clinical trials, as well as the way an interested party should submit an application. Table of Contents Switzerland’s regulating authority in the sphere of healthcare products,...
The new article highlights the key points related to the specific categories of changes and describes the way the regulatory status of such changes should be determined based on the nature of such changes, the impact they are expected to have on the safety and...
The new article highlights the aspects related to the applicable policy and outlines the key points to be taken into consideration. Table of Contents The Food and Drug Administration (FDA), the US regulating authority in the sphere of healthcare products, has...
The article highlights the key points related to the regulatory requirements for performance studies involving in vitro diagnostic medical devices. Table of Contents Swissmedic, a Swiss Agency for Therapeutic Products, has published an information sheet dedicated to...