Brazil
The new article provides details regarding the regulatory matters related to the responsibilities of the parties involved, telemedicine, accessories, and languages in the context of software as a medical device. Table of Contents The Brazilian regulating authority in...
Asia
The new article provides an overview of the regulatory framework for the importation of unregistered products to be used in the course of exhibitions. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare...
FDA
The new article provides additional details regarding the parental/guardian permission to be obtained before commencing an investigation, and also regarding the supporting data a study sponsor shall provide. Table of Contents The Food and Drug Administration (FDA or...
Australia and Oceania
The article describes in detail the approach to be applied for clinical evidence for implantable pulse generator systems and also highlights the key points to be considered in this respect, including the matters related to the scope of evidence to be provided. Table...
FDA
The new article highlights the key points to be taken into consideration with respect to endpoints in clinical studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
FDA
The new article highlights the main points related to the assessment of applicable risk, as well as the concept of direct benefit for study participants. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
