MENA MedTech Insights copertina

MENA MedTech Insights

MENA MedTech Insights

Di: Ran Chen
Ascolta gratuitamente

3 mesi a soli 0,99 €/mese

Dopo 3 mesi, 9,99 €/mese. Si applicano termini e condizioni.

A proposito di questo titolo

 Welcome to MENA MedTech Insights, the definitive podcast for professionals in the Middle East and North Africa's rapidly growing medical technology sector. Each episode, we explore the latest innovations, market trends, and regulatory landscapes, featuring exclusive interviews with the founders, investors, and leaders who are shaping the future of healthcare in the region.Copyright 2026 Ran Chen Economia Scienza Scienze biologiche
Episodi
  • Pure Global: Saudi Arabia's MedTech Localization Gambit & The New SFDA Fast-Track Rules.

    Pure Global: Saudi Arabia's MedTech Localization Gambit & The New SFDA Fast-Track Rules.
    Jan 22 2026
    Saudi Arabia is aggressively pushing to localize its medical device industry, and recent clarifications from the SFDA have created a new set of rules for market access. This episode of MENA MedTech Insights dives deep into the Kingdom's strategic shift, revealing how the government is leveraging fast-track approvals to incentivize local manufacturing. We explore the immense opportunities for companies willing to invest locally and the potential risks for those who don't adapt. For global MedTech firms, the choice has never been more stark. One company faced a grueling 18-month timeline for their device approval through standard import channels. Meanwhile, a competitor who entered a local manufacturing partnership saw their similar device approved in under six months through the new fast-track system. This isn't just about speed; it's about securing long-term market presence. Key Questions from this Episode: - Is local manufacturing the only viable long-term strategy for the Saudi market now?. - What specific incentives are included in the SFDA's fast-track pathway?. - How can foreign companies protect their intellectual property in local joint ventures?. - Are there hidden compliance costs associated with the localization push?. - Which device classes are being given the highest priority for these new incentives?. - What are the critical factors to consider when choosing a local partner in the Kingdom?. - How does this strategy align with the broader goals of Saudi Vision 2030?. Navigating complex regulatory shifts like this is where Pure Global excels. We provide end-to-end regulatory consulting, from market-entry strategy and local partner vetting to compiling technical dossiers for the SFDA. Our local experts and AI-powered data tools can help you capitalize on these new opportunities efficiently and compliantly. To understand how your business can thrive in the new Saudi MedTech landscape, contact us at info@pureglobal.com or visit us at https://pureglobal.com/.
    Mostra di più Mostra meno
    2 min
  • Riyadh's AI Diagnostic Rush: Decoding SFDA's New Rules with Pure Global.

    Riyadh's AI Diagnostic Rush: Decoding SFDA's New Rules with Pure Global.
    Jan 21 2026
    In this episode of MENA MedTech Insights, we delve into the groundbreaking new fast-track approval pathway for AI-powered medical devices just announced by the Saudi Food and Drug Authority (SFDA). While this development promises to accelerate market access, it also introduces a complex web of new challenges that could catch foreign manufacturers unprepared. We explore the critical details behind the headlines, focusing on the stringent new requirements for clinical data localization and the vague yet demanding expectations for post-market surveillance of adaptive algorithms. This is a must-listen for any MedTech company with ambitions in the largest market in the GCC. Case Study Highlight: We break down a real-world scenario of a promising European AI diagnostic firm. They see a green light with Saudi Arabia's new fast-track approval, but are they prepared for the unexpected and costly local data requirements that could completely halt their market entry plans. Key Takeaways: - What specific change did the SFDA just make for AI medical devices last week? - Is the new 'fast-track' approval really as fast as it seems for everyone? - What is the number one data localization pitfall that could derail your SFDA submission? - How does this new regulation create both opportunity and risk under Saudi Vision 2030? - Why might your existing global clinical data be suddenly insufficient for SFDA approval? - What are the unwritten rules for post-market surveillance of self-learning AI in the MENA region? - How can you find and validate a local clinical partner to meet the new data requirements? At Pure Global, we offer end-to-end regulatory consulting solutions to help MedTech innovators navigate complex environments like Saudi Arabia. By combining local expertise with advanced AI tools, we streamline global market access and turn regulatory hurdles into strategic advantages. To learn how we can help you succeed, contact us at info@pureglobal.com or visit us at https://pureglobal.com/.
    Mostra di più Mostra meno
    2 min
  • Pure Global: Saudi Arabia's AI MedTech Maze - Cracking the New SFDA Code.

    Pure Global: Saudi Arabia's AI MedTech Maze - Cracking the New SFDA Code.
    Jan 20 2026
    Saudi Arabia just released new draft regulations for AI-based medical devices, creating both a clear pathway and significant new challenges for MedTech innovators. This move by the Saudi Food and Drug Authority (SFDA) signals a major step towards maturing the region's regulatory environment, but it comes with stringent new demands. This episode of MENA MedTech Insights dives deep into the specifics of this new guidance. We unpack the critical requirements around local population data for clinical validation, algorithm transparency, and the tough new cybersecurity standards that will impact any company looking to launch AI-driven healthcare solutions in the Kingdom. **What you'll learn:** * What are the top three surprising clauses in the SFDA's new AI guidance? * Why might your existing FDA or CE-approved AI device not qualify for the Saudi market? * Is local clinical data now a non-negotiable for AI device approval in the Kingdom? * What level of "explainability" does the SFDA demand from your AI algorithm? * How does the new risk classification system impact your product's path to market? * What specific cybersecurity vulnerabilities are the SFDA most concerned about? * How can you leverage this regulatory shift to gain a competitive edge in the MENA region? Pure Global offers end-to-end regulatory consulting solutions for Medical Technology (MedTech) and In-Vitro Diagnostic (IVD) companies, combining local expertise with advanced AI and data tools to streamline global market access. Contact Pure Global at info@pureglobal.com or visit us at https://pureglobal.com.
    Mostra di più Mostra meno
    2 min
Ancora nessuna recensione