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...
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...
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...
Asia
The Philippines Food and Drug Administration (FDA) has published a circular implementing the interim guidelines describing the conduct of licensing inspections for radiation facilities. In the case of any discrepancies, the provisions of the new circular shall...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published a guidance document dedicated to the rights and responsibilities of the authorized representatives of the foreign medical device manufacturers. The scope of the document covers both pre-license and...
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