Saudi Arabia
The Saudi Food and Drugs Authority (SFDA), a country’s regulating agency responsible for medical devices, has published guidance dedicated to the marketing authorization procedures for medical devices. The document highlights the most important rules and requirements...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published several guidance documents addressing product-specific performance criteria for certain types of medical devices, including spinal plating systems and...
Europe
The National Center for Expertise of Medicines and Medical Devices (NDDA), a Kazakhstan`s body responsible for the premarket assessment of medical devices, has published an official announcement about the implementation of the new importation and exportation rules for...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a transcript of the virtual town hall dedicated to the guidance on Coronavirus (COVID-19) diagnostic tests issued earlier by the Agency. The conference...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority, has published an update regarding the ongoing process of improvement of the existing regulatory framework in the sphere of post-market monitoring and surveillance. In particular, the TGA...
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...
