Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority, has published a guidance document dedicated to the requirements for electronic instructions for use (eIFU) of medical devices. The document was initially published on August 22, 2019, for...
Asia
Saudi Arabia’s Food and Drug Authority has published its final guidance on the new Medical Device National Registry (MDNR), a streamlined market authorization pathway for low-risk medical devices. This new market route is specifically for Class I non-sterile and...
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