Asia
The article provides an overview of the applicable regulatory requirements concerning the cancelation of medical device registration. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
FDA
The new article covers the aspects related to stratification for subject selection, as well as to site selection in the context of pivotal clinical investigations. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Australia and Oceania
The new article describes in detail specific aspects related to the regulatory requirements for clinical evidence for cardiovascular devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
FDA
The new article describes in detail the principle of necessity and the way it should be applied. The article also covers the aspects related to risk categories for interventions or procedures without a prospect of direct benefit. Table of Contents The Food and Drug...
Brazil
The new article described in detail the aspects related to the evidence required for software products based on novel technologies, as well as to the determination of the regulatory status of the products depending on their functions and features. The Brazilian...
FDA
The new article highlights the key points related to the study objectives and subject selection in the context of pivotal clinical investigations. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
