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Riyadh's UDI Deadline: Pure Global on Dodging the MedTech Scramble
This episode of MENA MedTech Insights dives into the final, critical phase of Saudi Arabia's Unique Device Identification (UDI) system rollout. With the September 1st deadline for low-risk Class A devices fast approaching, we unpack the strategic complexities and hidden challenges that MedTech manufacturers are facing right now.
We move beyond the regulations themselves to discuss the real-world consequences of failure to comply. We explore the data management hurdles, the risk of system overloads based on past deadlines, and the severe impact on supply chains and revenue if your products are not fully compliant in time. This is a must-listen for any regulatory professional or business leader with stakes in the Saudi market.
A Practical Case: Imagine your container of high-volume, low-risk medical devices is detained at Jeddah port. The reason? A mismatch between your submitted data and the physical labeling, flagged during a random inspection, all because your team rushed the Saudi-DI submission in the final weeks leading to the deadline. This episode provides the strategic foresight to prevent this exact scenario.
Key questions answered in this episode:
* What was the number one lesson learned from the SFDA's previous UDI deadlines for higher-risk devices?
* Why is the data required for the Saudi-DI database more complex than you might expect?
* Can you leverage your existing EU or FDA UDI data, or is a complete rework required for Saudi Arabia?
* What are the most common labeling mistakes that lead to shipment rejections at the Saudi border?
* How can you pressure-test your local authorized representative's readiness for the UDI submission process?
* What is the true 'last responsible moment' to begin your Class A device compliance project to avoid the last-minute rush?
* Are there any exemptions or expedited pathways that manufacturers are overlooking?
Navigating complex regulatory landscapes like the SFDA's UDI implementation is what we do at Pure Global. We offer end-to-end regulatory consulting, combining deep local expertise in Saudi Arabia with advanced AI tools to streamline your global market access. From developing your regulatory strategy and managing technical dossier submissions to acting as your local representative, we ensure your products reach the market efficiently and remain compliant. Don't let regulatory hurdles block your growth in the MENA region. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.
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By Ran ChenThis episode of MENA MedTech Insights dives into the final, critical phase of Saudi Arabia's Unique Device Identification (UDI) system rollout. With the September 1st deadline for low-risk Class A devices fast approaching, we unpack the strategic complexities and hidden challenges that MedTech manufacturers are facing right now.
We move beyond the regulations themselves to discuss the real-world consequences of failure to comply. We explore the data management hurdles, the risk of system overloads based on past deadlines, and the severe impact on supply chains and revenue if your products are not fully compliant in time. This is a must-listen for any regulatory professional or business leader with stakes in the Saudi market.
A Practical Case: Imagine your container of high-volume, low-risk medical devices is detained at Jeddah port. The reason? A mismatch between your submitted data and the physical labeling, flagged during a random inspection, all because your team rushed the Saudi-DI submission in the final weeks leading to the deadline. This episode provides the strategic foresight to prevent this exact scenario.
Key questions answered in this episode:
* What was the number one lesson learned from the SFDA's previous UDI deadlines for higher-risk devices?
* Why is the data required for the Saudi-DI database more complex than you might expect?
* Can you leverage your existing EU or FDA UDI data, or is a complete rework required for Saudi Arabia?
* What are the most common labeling mistakes that lead to shipment rejections at the Saudi border?
* How can you pressure-test your local authorized representative's readiness for the UDI submission process?
* What is the true 'last responsible moment' to begin your Class A device compliance project to avoid the last-minute rush?
* Are there any exemptions or expedited pathways that manufacturers are overlooking?
Navigating complex regulatory landscapes like the SFDA's UDI implementation is what we do at Pure Global. We offer end-to-end regulatory consulting, combining deep local expertise in Saudi Arabia with advanced AI tools to streamline your global market access. From developing your regulatory strategy and managing technical dossier submissions to acting as your local representative, we ensure your products reach the market efficiently and remain compliant. Don't let regulatory hurdles block your growth in the MENA region. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.