Asia The Directorate General of Pharmaceutical Affairs and Drug Control, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements related to the registration of high-risk medical...
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(DGPA & DC), the regulating authority in the sphere of healthcare products of the Sultanate of Oman, has published draft guidance dedicated to regulatory requirements for the registration of...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), 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...
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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published draft guidance providing additional details regarding eSubmissions. The document is intended to assist medical device manufacturers...
