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PODCAST

MENA MedTech Insights

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.

science life sciences

All Episodes

01:51

Pure Global: Riyadh's AI Device Gambit - Unlocking...

MENA MedTech Insights ·

2026/02/10

In this episode of MENA MedTech Insights, we dissect the groundbreaking new policy from the Saudi Food and Drug Authority (SFDA). A new fast-track approval pathway for AI-enabled medical devices was launched last week, promising to slash market entry timelines from years to mere months. This move is a direct play to attract global innovation as part of the ambitious Vision 2030 plan.We explore what this regulatory shift means for international MedTech companies who previously saw the Kingdom as a

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02:12

Pure Global: Dubai's Sustainable MedTech - Beating...

MENA MedTech Insights ·

2026/02/09

The UAE has launched a 'Green Channel' for medical device approvals, a groundbreaking move that prioritizes sustainable MedTech. This policy offers a fast-track to market for eco-friendly products but introduces a complex new layer of 'green tape' for others. We dissect what this means for international manufacturers eyeing the lucrative Emirati market. This shift signals a new era for regulatory affairs in the Middle East, where environmental credentials have suddenly become as critical as

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02:03

Dubai's Diabetes Tech Gold Rush: Pure Global on Why...

MENA MedTech Insights ·

2026/02/08

This week on MENA MedTech Insights, we dive into the booming but complex market for diabetes technology in the Gulf region, sparked by a major new product launch. While the opportunity is massive, the barriers to entry are equally formidable, extending far beyond initial regulatory clearance.We explore the real-world hurdles facing even the biggest players in MedTech. We use the strategic push of a new Continuous Glucose Monitoring (CGM) system as a case study to reveal the hidden operational

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01:30

Pure Global: Dubai's Diabetes Tech Disruption -...

MENA MedTech Insights ·

2026/02/07

This week, we dive into one of the most significant MedTech launches in the Middle East this year. Global leader Roche has introduced its groundbreaking AI-powered predictive continuous glucose monitoring (CGM) system. We break down how this technology is set to transform diabetes care in a region with one of the highest prevalence rates globally. This move from reactive monitoring to proactive, AI-driven prediction is a game-changer for patients and a strategic challenge for competitors. We

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02:01

Pure Global: Saudi Arabia's New AI MedTech Playbook &...

MENA MedTech Insights ·

2026/02/06

Saudi Arabia is making a bold move to dominate the future of AI in healthcare. The Saudi Food and Drug Authority (SFDA) has just launched a dedicated Artificial Intelligence Laboratory (SAIL), fundamentally changing the rules for MedTech companies wanting to enter the region's largest market. This episode breaks down what this means for innovators, investors, and regulators.We explore the immediate impact of SAIL on regulatory timelines and submission requirements. We reveal why the SFDA is

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01:40

Saudi UDI Deadline Looms: Pure Global on Navigating...

MENA MedTech Insights ·

2026/02/05

This week on MENA MedTech Insights, we dissect the Saudi Food and Drug Authority's (SFDA) final deadline for Unique Device Identification (UDI) compliance. With the clock ticking towards March 2026, we explore why this is more than just a labeling change and how it's poised to disrupt the entire medical device supply chain in the Kingdom.This isn't just a regulatory hurdle; it's a complex data management and logistics challenge that could determine who leads and who lags in one of the Middle

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02:10

Pure Global: Saudi Arabia's AI Diagnostic Gold Rush &...

MENA MedTech Insights ·

2026/02/03

Saudi Arabia has just opened a lucrative fast-track for AI diagnostic software, promising market approval in weeks instead of months. This positions the Kingdom as a global hub for MedTech innovation and creates a massive opportunity for companies to tap into one of the world's most dynamic healthcare markets.However, this accelerated access comes with a critical catch. The Saudi Food & Drug Authority has tied this speed to some of the world's most demanding post-market surveillance requirements

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01:45

Pure Global: Saudi MedTech Localization - Decoding...

MENA MedTech Insights ·

2026/02/02

This week, we dissect the sudden shift in Saudi Arabia's medical device landscape. The Saudi Food and Drug Authority (SFDA) has rolled out new clarifications that radically favor local manufacturing and assembly, a direct push towards its Vision 2030 goals. This move fundamentally alters market access strategy for international MedTech firms.We explore what this means for companies that have relied on traditional import models. Imagine your state-of-the-art device, a market leader for years,

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01:40

Saudi Arabia's UDI Shockwave: Pure Global on SFDA's...

MENA MedTech Insights ·

2026/02/01

This week, we dissect the breaking news from Saudi Arabia as the SFDA unexpectedly accelerates the UDI compliance deadline for medium-risk medical devices. This sudden shift is forcing international MedTech companies to overhaul their supply chain and regulatory strategies overnight, risking market access and significant financial loss. We explore a real-world scenario facing a European IVD manufacturer, who now must confront the logistical nightmare of non-compliant inventory and accelerated data

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01:43

Saudi Arabia's MedTech Pivot: A Compliance Maze |...

MENA MedTech Insights ·

2026/01/31

This week on MENA MedTech Insights, we delve into the major news from Saudi Arabia. The Saudi Food and Drug Authority (SFDA) has just released new clarifications on its medical device localization initiative, a core component of Vision 2030. This move is set to fundamentally reshape one of the largest MedTech markets in the Middle East. We break down what these new rules mean for both international manufacturers and emerging local players. The changes introduce a complex new reality, creating

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02:07

Dubai's DTx Gambit: Pure Global on the Riayati...

MENA MedTech Insights ·

2026/01/30

The UAE has just launched an ambitious fast-track program for Digital Therapeutics (DTx), positioning itself as a premier destination for health tech innovation. This initiative promises rapid market access, but it comes with a significant challenge: a mandatory, time-sensitive integration with the national 'Riayati' health platform. This new rule is reshaping the entry strategy for all MedTech companies eyeing this lucrative market.This episode of MENA MedTech Insights breaks down what this new

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02:06

Saudi Arabia's UDI Crisis: The New Customs Trap |...

MENA MedTech Insights ·

2026/01/29

Saudi Arabia just activated a new, mandatory digital compliance step for all medical device imports. This sudden change by the Saudi Food and Drug Authority (SFDA) is creating immediate logistical challenges and threatens to delay shipments for any unprepared MedTech manufacturer trying to enter one of the Middle East's most valuable markets.This episode breaks down the new Medical Device National Registry (MDNR) linking program. We explore the specific data requirements, the tight deadlines, and

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01:51

Riyadh's New AI Rules: Cracking the SFDA Code with...

MENA MedTech Insights ·

2026/01/28

This week, we dissect the groundbreaking new AI and Machine Learning medical software guidelines released by the Saudi Food and Drug Authority (SFDA). This regulation, SFDA-AIML-03, introduces stringent requirements that will reshape market entry strategies for MedTech companies targeting Saudi Arabia, one of the largest markets in the MENA region.We explore the three core pillars of this new framework: the mandate for local data validation, the implementation of a unique national cybersecurity

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01:44

Riyadh's MedTech Firewall: Pure Global on SFDA's...

MENA MedTech Insights ·

2026/01/27

This week, we dissect the surprise release of Saudi Arabia's tough new cybersecurity regulations for medical devices. The SFDA's new mandate has left many manufacturers scrambling, with device approvals suddenly stalled. We explore the fine print of these new rules, the strategic intent behind them, and what it means for the future of MedTech in the Kingdom.This episode is for any MedTech innovator who thought they had their Saudi market access strategy finalized. We reveal how this sudden shift

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01:38

Riyadh's Digital Mandate: Pure Global on the MedTech...

MENA MedTech Insights ·

2026/01/26

In this episode, we dissect the sudden and mandatory shift by Saudi Arabia's SFDA to its new GHAD digital platform. This move has created significant operational challenges for international MedTech companies, freezing submissions and jeopardizing market access for those with unprepared local representatives. We explore the immediate consequences and the long-term strategic implications of this digital-first regulatory enforcement. This isn't a theoretical problem. Consider a real-world scenario

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01:38

Saudi AI MedTech: Pure Global on Cracking the SFDA's...

MENA MedTech Insights ·

2026/01/25

Saudi Arabia's new SFDA 'Digital Health Innovation Track' promises to slash approval times for AI medical devices, opening a lucrative door to one of the largest markets in the Middle East. This accelerated pathway is designed to attract cutting-edge technology and align with the ambitious goals of Vision 2030. However, this golden opportunity comes with a significant challenge: a strict new mandate for data localization. Global MedTech companies, accustomed to using international data sets for

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01:59

Riyadh's New MedTech Gambit: Pure Global on SFDA's...

MENA MedTech Insights ·

2026/01/24

This week on MENA MedTech Insights, we delve into the game-changing new "Medical Industry Localization Fast-Track" program just rolled out by the Saudi Food and Drug Authority (SFDA). This strategic initiative, a core component of Saudi Vision 2030, is set to drastically alter the landscape for medical device registration in the Kingdom, linking faster market access directly to local investment. We uncover the critical details of the program, from the promise of 60-day approval timelines to the

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01:23

Riyadh's Cyber Wall: Pure Global on SFDA's New...

MENA MedTech Insights ·

2026/01/23

This week, we dissect the surprise release of Saudi Arabia's tough new cybersecurity regulations for medical devices. The SFDA's new mandate is creating immediate hurdles for global MedTech firms, turning previously clear pathways to market into complex obstacle courses. We explore the specific technical requirements, the immediate impact on device approvals, and why this signals a major strategic shift in the MENA region's approach to digital health governance.We look at the real-world example of

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01:41

Pure Global: Saudi Arabia's MedTech Localization...

MENA MedTech Insights ·

2026/01/22

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

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02:08

Riyadh's AI Diagnostic Rush: Decoding SFDA's New...

MENA MedTech Insights ·

2026/01/21

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

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112 results

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