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...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance for importers and distributors. The document is intended to provide additional clarifications regarding the applicable rules and requirements the parties involved in operations with...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a discussion paper dedicated to the proposed regulatory framework for modifications to the software as a medical device (SaMD) based on the artificial...
Belgium
The Federal Agency for Medicines and Health Products (FAMHP), the Belgian regulating authority in the sphere of medical devices, has published updated guidelines for clinical trial sponsors. The document is intended to provide additional recommendations and...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance for local medical device manufacturers intended to provide additional clarifications and recommendations. The scope of the guidance covers aspects such as preparation for applying for...
