Asia
The article describes the regulatory procedures to be followed when changing a registrant of a medical device. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document...
FDA
The article provides an overview of the applicable regulatory requirements for ethical considerations in the context of clinical investigations of medical devices initially intended to be used for children. Table of Contents The Food and Drug Administration (FDA or...
Australia and Oceania
The new article highlights the key points related to the regulatory evidence for cardiovascular devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulatory agency in the sphere of healthcare products, has published a guidance...
FDA
The new article highlights the key points related to the principles for the choice of clinical study design, such as bias and variability and the way they can affect the accuracy and reliability of the results. Table of Contents The Food and Drug Administration (FDA...
Asia
The article provides an overview of the regulatory requirements for specific Change Notification applications. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document...
FDA
The new article describes in detail the aspects to be considered when identifying a medical device recall to distinguish it from other actions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
