Webinar: Comparison Between the SFDA's New Regulations and the EU MDR
In today's webinar, Priya Bhutani introduced a presentation comparing new Saudi FDA medical device regulations with the EU MDR. Her colleague, Baraa Nofal, will focus on key similarities, particularly in device classification and registration requirements. Priya provided an overview of RegDesk's capabilities, emphasizing their platform's efficiency in managing regulatory submissions.
Baraa highlighted that while both regulations involve a similar framework for classifying medical devices based on risk, there are slight differences in naming conventions. She discussed the importance of manufacturers determining device classifications and the need for thorough technical documentation, including essential safety and performance principles.
The session aims to clarify the new Saudi requirements and answer attendee questions, encouraging participation throughout the presentation.
At the end, they will address any additional questions and offer to schedule further discussions as needed!