Uncategorized The Directorate General of Pharmaceutical Affairs & Drug Control (DGPA & DC), the regulating authority in the sphere of healthcare products of the Sultanate of Oman, has published draft guidance dedicated to regulatory requirements for the registration of...
FDA The Food and Drug Administration (FDA or the Agency) has published a guidance document dedicated to the De Novo Process and requests associated thereto. The document provides an overview of the applicable regulatory requirements and is intended to assist medical...
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 the De Novo classification process and regulatory framework associated thereto. Table of Contents Due...
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...
