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The Gatekeeper: Unlocking the UAE MedTech Market with the Right Local Partner

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Manage episode 508392171 series 3667504
Content provided by Pure Global. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Pure Global or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
This episode delves into the mandatory requirement for a Local Authorized Representative (LAR) when bringing a medical device to the United Arab Emirates market. We explore the critical functions of the LAR as the interface with the Ministry of Health and Prevention (MOHAP), their legal responsibilities for product registration and post-market vigilance, and the strategic importance of selecting an independent representative over a commercial distributor. Key Questions: • Is a local representative mandatory for selling medical devices in the UAE? • What are the core responsibilities of a Local Authorized Representative (LAR)? • Who legally holds the medical device registration license in the UAE? • How does an LAR interact with the UAE's Ministry of Health and Prevention (MOHAP)? • What is the LAR's role in post-market surveillance, vigilance, and recalls? • What are the risks of appointing a commercial distributor as your authorized representative? • Why is selecting an LAR a critical strategic decision for market access and control? • Can you change distributors if your device registration is held by them? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.
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149 episodes

Artwork
iconShare
 
Manage episode 508392171 series 3667504
Content provided by Pure Global. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Pure Global or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
This episode delves into the mandatory requirement for a Local Authorized Representative (LAR) when bringing a medical device to the United Arab Emirates market. We explore the critical functions of the LAR as the interface with the Ministry of Health and Prevention (MOHAP), their legal responsibilities for product registration and post-market vigilance, and the strategic importance of selecting an independent representative over a commercial distributor. Key Questions: • Is a local representative mandatory for selling medical devices in the UAE? • What are the core responsibilities of a Local Authorized Representative (LAR)? • Who legally holds the medical device registration license in the UAE? • How does an LAR interact with the UAE's Ministry of Health and Prevention (MOHAP)? • What is the LAR's role in post-market surveillance, vigilance, and recalls? • What are the risks of appointing a commercial distributor as your authorized representative? • Why is selecting an LAR a critical strategic decision for market access and control? • Can you change distributors if your device registration is held by them? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.
  continue reading

149 episodes

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