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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

01:57

Pure Global: Saudi Arabia's MedTech Ambush - Cracking...

MENA MedTech Insights ·

2026/01/16

In this episode of MENA MedTech Insights, we dissect a major regulatory enforcement action from Saudi Arabia's SFDA that took effect last week. The Kingdom has rolled out immediate, stricter requirements for its Unique Device Identification (UDI) system, specifically targeting Class IIa and IIb devices and creating immediate challenges for foreign manufacturers.This move is a core part of Saudi Arabia's push to elevate its healthcare standards, but it's leaving many companies scrambling. We

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01:54

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

MENA MedTech Insights ·

2026/01/15

In this episode, we dissect the breaking news from last week that's sending shockwaves through the MENA MedTech industry. The Saudi Food and Drug Authority (SFDA) has just rolled out immediate, mandatory cybersecurity regulations for all connected medical devices, fundamentally changing the rules for market access. This move impacts everything from new product submissions to devices already in use across the Kingdom, setting a new precedent for the entire region.We explore the fine print of these

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01:44

Pure Global: Saudi UDI Shockwave - Navigating...

MENA MedTech Insights ·

2026/01/13

This week on MENA MedTech Insights, we dissect the breaking news from Riyadh. The Saudi Food and Drug Authority (SFDA) has just issued an accelerated deadline for full UDI compliance, catching many international MedTech firms by surprise and forcing a frantic race to update their systems and documentation. This episode provides a detailed analysis of what this regulatory shift entails and the immediate strategic implications for device manufacturers.We explore the specific technical challenges

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02:00

Pure Global: Saudi Arabia's AI MedTech Rush & The...

MENA MedTech Insights ·

2026/01/12

This week on MENA MedTech Insights, we dissect the groundbreaking news from Saudi Arabia. The SFDA has just launched an ambitious fast-track approval pathway for AI and Machine Learning medical devices, aiming to attract global innovators. This move could slash market entry timelines but introduces complex new challenges that could trap unprepared companies. We explore the specific requirements of this new regulation, focusing on the critical need for locally relevant clinical data. This episode is

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01:50

Pure Global: UAE & Saudi's Secret MedTech Handshake -...

MENA MedTech Insights ·

2026/01/11

This week, we uncover a major shift in the GCC's MedTech landscape. The UAE has launched a new "Green Channel" pilot program, offering a fast-track approval pathway for devices already registered in Saudi Arabia. This could fundamentally change how manufacturers approach the region, creating a powerful "one-two" punch for market access.While this development promises to slash timelines and costs, it's packed with hidden requirements that could trap unprepared companies. The program demands a

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01:31

Riyadh's AI Diagnostic Shockwave: Pure Global on...

MENA MedTech Insights ·

2026/01/10

In this episode of MENA MedTech Insights, we dissect the breaking news from Saudi Arabia. The Saudi Food and Drug Authority (SFDA) has abruptly launched a new, mandatory regulatory framework for AI-powered medical software, sending shockwaves through the industry. This sudden change creates immediate and complex challenges for MedTech innovators targeting the Saudi market. We explore the critical new requirements, including mandatory in-kingdom data hosting and the submission of a novel 'Algorithm

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01:54

Saudi AI MedTech's Cyber Shock: Pure Global on...

MENA MedTech Insights ·

2026/01/09

In the fast-evolving MENA MedTech landscape, Saudi Arabia has just raised the bar for market entry. This episode of MENA MedTech Insights unpacks the new, mandatory cybersecurity framework for AI-powered medical devices enforced by the Saudi Food & Drug Authority (SFDA) in the first week of January 2026. We dissect this sudden regulatory shift and its immediate impact on global manufacturers aiming to enter one of the region's most lucrative markets.We delve into the specific technical

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01:41

Riyadh's AI Diagnostic Gold Rush: Pure Global on...

MENA MedTech Insights ·

2026/01/08

In this episode, we dissect the groundbreaking new Medical AI Fast-Track (MAFT) program just launched by Saudi Arabia's Food and Drug Authority (SFDA). This policy promises to dramatically accelerate market access for AI-driven medical devices, but it comes with a significant and complex challenge that could stall even the most prepared companies.We explore the hidden complexities of the SFDA's new National Health Data Sovereignty clause. A European AI diagnostics firm, poised to benefit from the

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01:48

Pure Global: Saudi Arabia's New AI MedTech Rule—The...

MENA MedTech Insights ·

2026/01/07

In this episode of MENA MedTech Insights, we dissect a pivotal new regulatory guidance document from the Saudi Food and Drug Authority (SFDA). Released in the final week of 2025, this update specifically targets the clinical data requirements for AI-powered medical devices, introducing a major challenge for international manufacturers. We explore how the SFDA is now pushing for clinical validation that includes local MENA population data to combat algorithmic bias. This shift presents a significant

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01:38

Pure Global: Dubai's DTx Gold Rush - Decoding the...

MENA MedTech Insights ·

2026/01/06

This week on MENA MedTech Insights, we dissect the groundbreaking new regulatory framework for Digital Therapeutics (DTx) just launched by the UAE's Ministry of Health and Prevention (MOHAP). This policy creates a dedicated, clear approval pathway for software-based treatments, ending the uncertainty that previously stalled market access for this innovative class of MedTech.This episode is essential for any digital health innovator targeting the Gulf. We analyze the specific requirements of the

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01:51

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

MENA MedTech Insights ·

2026/01/05

This week on MENA MedTech Insights, we dissect the big news from Saudi Arabia. The SFDA has just launched an exciting fast-track approval process for AI-powered medical software, promising to open the market to global innovators faster than ever before. This move signals the Kingdom's strong commitment to becoming a hub for digital health technology. But while the headlines promise speed, the fine print reveals significant challenges. The new framework includes demanding data localization laws, a

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01:40

Pure Global: Saudi Arabia's SaMD Shift - The Hidden...

MENA MedTech Insights ·

2026/01/04

This episode unpacks a critical update from the Saudi Food and Drug Authority (SFDA) that is reshaping the landscape for digital health and Software as a Medical Device (SaMD) in the Kingdom. As Saudi Arabia tightens its requirements, we explore the new, unwritten rules around cybersecurity and data integrity that are becoming a major hurdle for market access.We dive into the practical implications of these changes. This is not just about new paperwork; it's about a fundamental shift in how the

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01:52

UAE Digital Health: Pure Global on Cracking the...

MENA MedTech Insights ·

2026/01/03

In this episode, we dissect a pivotal, late-2025 development from the United Arab Emirates that is set to redefine the MedTech landscape in 2026. As the holiday season concluded, the UAE's health authorities released a new draft guidance targeting digital health, AI, and software as a medical device (SaMD), signaling a major regulatory shift. We explore the specific, stringent new requirements for cybersecurity and the mandate for locally sourced real-world evidence. This change presents both a

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01:53

Riyadh's AI Diagnosis Maze: Decoding SFDA's New Rules...

MENA MedTech Insights ·

2026/01/02

This week on MENA MedTech Insights, we dissect the major regulatory shift from the Saudi Food and Drug Authority (SFDA). The release of new guidance for AI and Machine Learning-based medical devices has created new, complex challenges for manufacturers aiming to enter the Saudi market. We provide an insider's look at what these changes mean for your business. We explore the specific demands of the new framework, moving beyond surface-level updates. We break down the stringent requirements for

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02:08

Pure Global: KSA's EU MDR Bridge & The Hidden...

MENA MedTech Insights ·

2025/12/22

The Saudi Food and Drug Authority (SFDA) just opened a new fast-track for EU MDR-approved medical devices. This move is set to reshape market entry strategy for Saudi Arabia, creating a massive opportunity for global manufacturers with a CE Mark. But this "bridge" to market access is not as simple as it seems and is filled with local requirements that can trip up even experienced regulatory teams.This episode breaks down the new policy, revealing the hidden complexities behind the headlines. We

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01:43

Saudi Arabia's Cyber Rules: The Hidden MedTech Hurdle...

MENA MedTech Insights ·

2025/12/21

Last week, Saudi Arabia's SFDA implemented a pivotal update to its safety framework, introducing stringent new cybersecurity regulations for connected medical devices. This move, while aimed at enhancing patient safety, creates a complex new layer of compliance for manufacturers, potentially stalling market entry for those unprepared for the specific local requirements that exceed current EU and US standards.This episode delves into the real-world impact of these changes. We examine the case of a

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01:49

Riyadh's AI MedTech Rush: Cracking the SFDA's Hidden...

MENA MedTech Insights ·

2025/12/20

This week on MENA MedTech Insights, we dissect the groundbreaking new fast-track approval pathway for AI-based medical devices announced by the Saudi Food and Drug Authority (SFDA). This move catapults Saudi Arabia to the forefront of digital health adoption, presenting a massive opportunity for global innovators. However, behind the promise of rapid market access lies a complex web of new, localized post-market surveillance requirements. We explore the SFDA's focus on eliminating algorithmic bias

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00:39

Riyadh's AI MedTech Rush: Pure Global on SFDA's...

MENA MedTech Insights ·

2025/12/19

Saudi Arabia is opening its doors to AI-powered medical devices with a new "fast-track" approval process. But behind the promise of speed lies a maze of complex new requirements that could trap unprepared companies. This episode of MENA MedTech Insights unpacks the SFDA's latest guidance, revealing the hidden challenges in algorithm validation and data localization.We explore a real-world scenario where a promising European AI startup, targeting the lucrative Saudi market, saw their launch

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01:55

Pure Global: Saudi Arabia's New MedTech Play. The EU...

MENA MedTech Insights ·

2025/12/18

This week on MENA MedTech Insights, we dissect the groundbreaking new policy from the Saudi Food and Drug Authority (SFDA). In a move set to redefine market access, the SFDA has announced a major harmonization with the European Union's Medical Device Regulation (MDR) for Class IIa and IIb devices.This policy creates a powerful new "regulatory bridge," drastically simplifying the pathway for EU-compliant devices to enter the Saudi market. We explore the immense opportunities this presents, not just

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01:47

Saudi MedTech's New Rules: Pure Global on The...

MENA MedTech Insights ·

2025/12/17

This week, we dive deep into a seismic shift in Saudi Arabia's MedTech market. Recent regulatory updates are aggressively prioritizing local manufacturing, creating new, complex challenges for international medical device companies wanting to enter or stay in the Kingdom. We explore what these changes mean on the ground and how firms can turn this potential barrier into a strategic advantage.We unpack a real-world scenario where a leading European IVD manufacturer's multi-million dollar tender was

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