Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory matters related to in vitro diagnostics (IVD) analyzers and accessories thereto. Table of Contents...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document on infusion pumps. Table of Contents The document addresses the most important...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to software intended to be used with in vitro diagnostic medical devices during the outbreak of...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance describing the electronic submission template to be used for medical device 510(k) submissions. The document is...
Asia
The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for promoting and advertising medical devices. The document is intended to provide...
