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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

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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02:04

Riyadh's AI MedTech Rush: Unpacking the SFDA's...

MENA MedTech Insights ·

2025/12/16

This week on MENA MedTech Insights, we dissect the groundbreaking news from Saudi Arabia. The SFDA has just launched a new accelerated approval pathway for AI-driven medical devices, promising to slash market entry timelines. But is this new "golden ticket" too good to be true? We explore the fine print behind this opportunity, revealing the stringent new post-market surveillance and data localization demands that are catching many international companies off guard. This is a must-listen for any

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02:13

Pure Global: Decoding Riyadh's New MedTech Rules &...

MENA MedTech Insights ·

2025/12/15

This week, MENA MedTech Insights dives into the seismic regulatory shifts in Saudi Arabia. The SFDA's new product safety framework is reshaping the market access landscape for medical device manufacturers, demanding a higher standard of clinical evidence and post-market surveillance that catches many international companies off guard. We break down what these enhanced requirements for technical documentation and vigilance mean for your business, and why the old methods of entering the lucrative

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01:57

Riyadh's MedTech Revolution: Pure Global on Saudi's...

MENA MedTech Insights ·

2025/12/14

Saudi Arabia is rewriting its MedTech rulebook. Driven by Vision 2030, the Saudi Food and Drug Authority (SFDA) is rolling out new regulations and incentives designed to shift the country from a top medical device importer to a powerful local manufacturing hub. This move creates immense opportunities for innovators but presents complex strategic challenges for established international companies.This episode of MENA MedTech Insights dives deep into these changes. We analyze how the new push for

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01:54

Pure Global: Saudi MedTech's New Rules - Decoding the...

MENA MedTech Insights ·

2025/12/13

The MENA MedTech market is booming, but a new wave of complex regulations is creating significant challenges for market entry and growth. This episode of MENA MedTech Insights dives deep into the upcoming 2025 MEA MedTech Regulatory Summit, a pivotal event that signals a major shift in the region's approach to medical device and digital health oversight. We unpack the critical discussions that will shape the future for manufacturers in Saudi Arabia, the UAE, and beyond. We explore the real-world

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01:37

Pure Global: Saudi Arabia's New SFDA Hurdle for...

MENA MedTech Insights ·

2025/12/12

This week on MENA MedTech Insights, we dissect the latest regulatory earthquake from the Saudi Food & Drug Authority (SFDA). As part of its Vision 2030, Saudi Arabia has issued new mandates that effectively require foreign medical device manufacturers to establish local production partnerships. This is a game-changer for anyone operating in or considering entry into the lucrative Saudi market. We explore what this means for manufacturers of Class IIa and IIb devices, who must now submit a detailed

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02:18

Saudi Arabia's AI MedTech Gambit: Pure Global on...

MENA MedTech Insights ·

2025/12/11

In this episode of MENA MedTech Insights, we dissect Saudi Arabia's groundbreaking new regulatory framework for AI-powered medical devices and Software as a Medical Device (SaMD). The Saudi Food and Drug Authority (SFDA) is raising the bar, introducing complex requirements for cybersecurity, data management, and local clinical validation that will reshape market access strategies. We explore how this move aligns with Saudi Vision 2030 and what it means for global MedTech manufacturers. This isn't

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01:51

Pure Global: Dubai's AI MedTech Sandbox, Unpacking...

MENA MedTech Insights ·

2025/12/10

This week on MENA MedTech Insights, we're diving into the United Arab Emirates' groundbreaking new regulatory sandbox for AI-powered medical devices. This initiative, launched just last week, is set to revolutionize how innovative MedTech gets to market, creating a fast-track for startups and challenging the traditional, slower approval processes. We explore what this new framework means for the region's burgeoning digital health scene. We look at the specific case of 'Cardio-AI,' a local startup

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01:33

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

MENA MedTech Insights ·

2025/12/09

The MedTech sector in the Gulf is experiencing a transformative phase, with new reports forecasting a significant wave of mergers and acquisitions. This episode of MENA MedTech Insights delves into the driving forces behind this investment boom, exploring how government diversification strategies and a strong push towards digital transformation are reshaping the industry. We connect this financial trend to the region's growing appetite for cutting-edge technology, highlighting the Intelligent

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02:20

MENA MedTech Insights: Pure Global's Guide to...

MENA MedTech Insights ·

2025/10/18

The MENA region is a goldmine for MedTech innovation, but its complex and fragmented regulatory landscape can be a major barrier to entry. This episode of MENA MedTech Insights dives deep into the two largest markets: Saudi Arabia and the United Arab Emirates.We uncover the most common pitfalls companies face, from underestimating the SFDA's unique documentation demands to misunderstanding the critical role of a local Authorized Representative in the UAE. This is a practical guide for any MedTech

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02:08

Pure Global's MENA MedTech Playbook: Navigating Saudi...

MENA MedTech Insights ·

2025/10/17

This episode of MENA MedTech Insights dives into the critical regulatory nuances for medical device companies expanding into the MENA region, particularly those with existing EU supply chains and approvals. We uncover why a CE mark is only the beginning of the journey and explore the growing divergence between EU standards, like EUDAMED, and the specific requirements of key markets like Saudi Arabia and the UAE. We break down the common assumption that EU compliance guarantees smooth entry into the

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01:52

MENA MedTech Strategy: Why Saudi Arabia & UAE Demand...

MENA MedTech Insights ·

2025/10/16

In this episode of MENA MedTech Insights, we explore the number one reason why medical device companies fail when entering markets like Saudi Arabia and the UAE: a lack of upfront regulatory clarity. We break down why a detailed understanding of the authorities, device classifications, and submission mechanics is non-negotiable *before* a single dollar of the budget is spent.Discover the common pitfalls that lead to massive budget overruns and months of delays. We use the real-world example of a

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02:12

Unlocking MENA MedTech Markets: How Pure Global Turns...

MENA MedTech Insights ·

2025/10/15

Expanding your MedTech footprint in the MENA region is far more complex than a single market entry. Each country, from Saudi Arabia to the UAE, presents unique regulatory and commercial hurdles. This episode of MENA MedTech Insights dives into a powerful strategy: using your initial regulatory submission as the blueprint for rapid, compliant, and successful cross-regional scaling. We explore the critical details of this approach through a common scenario. Imagine a company gains market approval in

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02:00

Unlocking MENA's MedTech Markets: How Pure Global...

MENA MedTech Insights ·

2025/10/14

This episode of MENA MedTech Insights dives into the complexities of entering the region's top markets: Saudi Arabia, the UAE, Egypt, and Israel. We explore the common pitfalls of using separate vendors for each country's unique regulatory hurdles and reveal how a unified market-access strategy can dramatically accelerate growth and reduce costs.We break down how a single-partner approach streamlines everything from initial registration to post-market surveillance. Instead of juggling multiple

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02:15

Pure Global's MENA MedTech Insights: Decoding the...

MENA MedTech Insights ·

2025/10/13

The MENA MedTech market is booming, but its regulatory landscape is a minefield of constant updates. Authorities like the Saudi FDA are frequently amending rules, and a single missed update can derail your entire market access strategy, costing you time and money. This episode dives into the critical importance of continuous regulatory monitoring. We explore real-world examples, such as a recent SFDA guidance update that invalidated carefully prepared submissions overnight. We also discuss the

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