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Unlock the UAE MedTech Market: Pure Global's Expert Breakdown of Cabinet Decision No. 58 of 2022 for MENA Compliance
In this episode of MENA MedTech Insights, we dissect the UAE's transformative Cabinet Decision No. 58 of 2022. This new regulation is a critical hurdle for any MedTech or IVD company looking to enter or remain in this key Middle Eastern market. We provide a clear, actionable breakdown of the most significant changes you need to be aware of.
We explore the three core pillars of the new legislation: the mandatory implementation of the Unique Device Identification (UDI) system, the heightened requirements for proactive Post-Market Surveillance (PMS), and the expanded legal responsibilities of the in-country Authorized Representative. We go beyond the theory to discuss the real-world operational impact these changes have on manufacturers, from labeling and data submission to clinical data collection.
A European manufacturer with a CE-marked device thought entering the UAE would be straightforward. They were wrong. The new UDI requirements and stringent post-market surveillance rules under Cabinet Decision No. 58 created unexpected six-month delays and significant costs when their technical file was rejected for non-compliance. Find out how you can avoid their critical mistakes and streamline your path to market.
**In this Episode:**
* How does the UAE's new UDI system differ from the EU and US models, and what does it mean for your labeling process?
* What are the three most common mistakes companies make when updating their Post-Market Surveillance plans for the UAE?
* Is your current Authorized Representative truly compliant with the stricter legal liabilities under Decision 58?
* Why might your existing CE-marked technical file be rejected by the UAE authorities?
* What are the specific upcoming deadlines you absolutely cannot miss for UDI implementation?
* How can you leverage the new regulation to gain a competitive advantage in the MENA region?
At Pure Global, we transform these regulatory hurdles into market opportunities. Our end-to-end solutions combine local UAE expertise with advanced AI tools to streamline your market access. Don't let regulatory complexity slow your growth. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can accelerate your entry into the UAE market.
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By Ran ChenIn this episode of MENA MedTech Insights, we dissect the UAE's transformative Cabinet Decision No. 58 of 2022. This new regulation is a critical hurdle for any MedTech or IVD company looking to enter or remain in this key Middle Eastern market. We provide a clear, actionable breakdown of the most significant changes you need to be aware of.
We explore the three core pillars of the new legislation: the mandatory implementation of the Unique Device Identification (UDI) system, the heightened requirements for proactive Post-Market Surveillance (PMS), and the expanded legal responsibilities of the in-country Authorized Representative. We go beyond the theory to discuss the real-world operational impact these changes have on manufacturers, from labeling and data submission to clinical data collection.
A European manufacturer with a CE-marked device thought entering the UAE would be straightforward. They were wrong. The new UDI requirements and stringent post-market surveillance rules under Cabinet Decision No. 58 created unexpected six-month delays and significant costs when their technical file was rejected for non-compliance. Find out how you can avoid their critical mistakes and streamline your path to market.
**In this Episode:**
* How does the UAE's new UDI system differ from the EU and US models, and what does it mean for your labeling process?
* What are the three most common mistakes companies make when updating their Post-Market Surveillance plans for the UAE?
* Is your current Authorized Representative truly compliant with the stricter legal liabilities under Decision 58?
* Why might your existing CE-marked technical file be rejected by the UAE authorities?
* What are the specific upcoming deadlines you absolutely cannot miss for UDI implementation?
* How can you leverage the new regulation to gain a competitive advantage in the MENA region?
At Pure Global, we transform these regulatory hurdles into market opportunities. Our end-to-end solutions combine local UAE expertise with advanced AI tools to streamline your market access. Don't let regulatory complexity slow your growth. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can accelerate your entry into the UAE market.