Asia
The article addresses the aspects related to the content of labeling for various types of medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a...
Asia
The first article describes the regulatory background for labeling requirements, provides definitions of key terms, and also highlights the main points related to the general requirements for labeling including the way the safety and use-related information should be...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a detailed guidance document dedicated to labeling requirements for various types of medical devices, including in vitro diagnostic...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a general guidance document dedicated to labeling for medical devices. The document describes in detail the general labeling...
FDA
The Food and Drug Administration (FDA or the Agency), the country’s regulating authority in the sphere of healthcare products, has developed detailed guidelines dedicated to labeling requirements for various types of medical devices. The present article supplements...
