Asia
The article provides an overview of the Singaporean regulatory requirements for advertising medical devices marketed in the country. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
FDA
The article provides an overview of the regulatory provisions related to the definition of a medical device as set forth by the existing legislation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Brazil
The article addresses the aspects related to the products used for the provision of telemedicine services. Table of Contents The Brazilian regulating authority in the sphere of healthcare products (ANVISA) has published a guidance document dedicated to the regulatory...
FDA
The new article highlights the key points to be considered for the placebo effect in the context of clinical investigations and also outlines the measures to be taken to mitigate this effect and its impact on the study results and data collected in the course of a...
Australia and Oceania
The new article describes in detail the aspects related to the clinical evidence required for meshes, patches, and tissue adhesives. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products,...
FDA
The new article highlights the key points related to study procedures in pediatric clinical investigations, and also provides a summary of the key points addressed in the guidance. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
