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 medical device reporting. The present article focuses on the reporting requirements of medical device...
Canada Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document is intended to assist medical device manufacturers and other parties involved in...
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 medical device reporting for manufacturers. Table of Contents The document is intended to provide...
Australia and Oceania The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has announced the ongoing improvement of its incident reporting framework in order to ensure the safety and effectiveness of...
Canada Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the new regulatory framework, which becomes effective from June 23, 2021. The document provides additional...
