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Navigating the UAE's 2025 MedTech Shake-Up: A Pure Global Guide to the New EDE and Federal Law No. 38
In this episode, MedTech Global Insights breaks down the UAE's transformative new Federal Decree-Law No. 38 of 2024. We explore the most critical change for the MedTech and IVD industries: the transfer of regulatory power from the Ministry of Health and Prevention (MOHAP) to the newly formed Emirates Drug Establishment (EDE), set to take effect in early 2025.
We analyze the immediate implications for manufacturers, covering everything from the handling of in-flight registration applications to expanded obligations for software as a medical device and post-market surveillance. This episode provides essential insights into how this strategic move by the UAE government aims to create a world-class, globally aligned regulatory environment and what it means for your business.
Case Study: A European IVD manufacturer's product registration is up for renewal in mid-2025. Their local distributor, who previously managed the simple renewal process with MOHAP, is now unprepared to handle the completely new submission process required by the EDE. With their market access and revenue stream at immediate risk, the manufacturer must quickly find expert guidance to navigate the new framework or face being locked out of the market.
Key Takeaways:
- What are the three most significant changes introduced by the UAE's Federal Law No. 38 of 2024?
- How will the new Emirates Drug Establishment (EDE) change the market registration process?
- My product is already registered with MOHAP. What immediate steps should I take to ensure compliance continuity?
- Does the new law affect the requirements for a local Authorized Representative in the UAE?
- How might the expanded definition of "medical products" impact our software (SaMD) and borderline devices?
- What new post-market surveillance obligations should our company be preparing for?
- Is this regulatory shift an opportunity or a threat for new MedTech startups looking to enter the UAE?
- How does the UAE's new framework compare to regulatory standards in the EU or Saudi Arabia?
For inquiries, contact us at [email protected] or visit https://pureglobal.com/.
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By Ran ChenIn this episode, MedTech Global Insights breaks down the UAE's transformative new Federal Decree-Law No. 38 of 2024. We explore the most critical change for the MedTech and IVD industries: the transfer of regulatory power from the Ministry of Health and Prevention (MOHAP) to the newly formed Emirates Drug Establishment (EDE), set to take effect in early 2025.
We analyze the immediate implications for manufacturers, covering everything from the handling of in-flight registration applications to expanded obligations for software as a medical device and post-market surveillance. This episode provides essential insights into how this strategic move by the UAE government aims to create a world-class, globally aligned regulatory environment and what it means for your business.
Case Study: A European IVD manufacturer's product registration is up for renewal in mid-2025. Their local distributor, who previously managed the simple renewal process with MOHAP, is now unprepared to handle the completely new submission process required by the EDE. With their market access and revenue stream at immediate risk, the manufacturer must quickly find expert guidance to navigate the new framework or face being locked out of the market.
Key Takeaways:
- What are the three most significant changes introduced by the UAE's Federal Law No. 38 of 2024?
- How will the new Emirates Drug Establishment (EDE) change the market registration process?
- My product is already registered with MOHAP. What immediate steps should I take to ensure compliance continuity?
- Does the new law affect the requirements for a local Authorized Representative in the UAE?
- How might the expanded definition of "medical products" impact our software (SaMD) and borderline devices?
- What new post-market surveillance obligations should our company be preparing for?
- Is this regulatory shift an opportunity or a threat for new MedTech startups looking to enter the UAE?
- How does the UAE's new framework compare to regulatory standards in the EU or Saudi Arabia?
For inquiries, contact us at [email protected] or visit https://pureglobal.com/.