With a robust economy and a population exceeding 35 million, Saudi Arabia represents a significant market for medical devices in the Middle East. The country's health care system is undergoing rapid expansion, marked by substantial investments in infrastructure and enhanced access to medical devices. The Saudi Food and Drug Authority (SFDA) plays a pivotal role in medical device registration in Saudi Arabia, whether imported or locally manufactured. Saudi Arabia is renowned for its advanced healthcare services and boasts the largest medical device market in the MENA region.
Our weekly regulatory news round-up includes the US FDA's debut of “Elsa,” an agency-wide generative-AI platform to speed reviews and boost efficiency. In addition, Mexico’s COFEPRIS announced sweeping Plan Mexico reforms aimed at digitizing procedures, reclassifying 2,200 devices, and slashing clinical-protocol review times in a bid to become a WHO-listed authority.
This webinar was hosted by Dr. Oliver Eikenberg and featured our Guest Speaker, Ms. Eva Camatini, Notified Body - IMQ.
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