Australia
The article provides an overview of the regulatory requirements various sterility products are subject to in order to be allowed for marketing and use in Australia.
Swissmedic
The article outlines the key points related to Swissdamed, the country’s new information system for healthcare products.
Australia
The new article addresses the regulatory matters related to digital mental health tools, explaining the requirements such products are subject to in accordance with the existing legal framework.
FDA
The article highlights the key points regarding the approach to be followed in order to ensure healthcare professionals and patients are provided with accurate, factually correct, and up-to-date information about healthcare products.
FDA
The new article further describes in detail the scope of matters covered by the guidance, as well as the relevant legal background.
Australia
The new article clarifies the exclusion requirements for the software products intended to be used for communication purposes, as well as for administration of healthcare facilities.
