Russia Roszdravnadzor, the Russian regulating authority in the sphere of medical devices, has published a regulation on state control (supervision) over the circulation of medical devices. The document sets forth the rules and requirements in the sphere of state supervision...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to surgical staplers and staples. In particular, the document is intended to provide additional...
Asia The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to software medical devices in the context of a life cycle approach. The document provides...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to surgical staplers and staples for internal use. The document provides additional recommendations...
Australia and Oceania The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document describes in detail the procedures to be followed...
