FDA The article describes in detail the way the medical device manufacturer may apply for exemptions from general reporting requirements, as well as the information to be included in the appropriate request. Table of Contents The Food And Drug Administration (FDA...
Australia and Oceania The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published a questions-and-answers document addressing the most important aspects related to software-based medical devices. The document is intended to...
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...
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...
Asia The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a guidance document dedicated to software medical devices. In particular, the document describes a life cycle approach and the way it should be...
