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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

02:20

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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02:07

MENA MedTech Insights by Pure Global: A Deep Dive...

MENA MedTech Insights ·

2025/10/12

In this episode of MENA MedTech Insights, we delve into the lucrative yet complex Israeli medical device market. We uncover the critical regulatory hurdles and requirements set by AMAR, the medical device division of Israel's Ministry of Health, and explain why securing a knowledgeable local partner is paramount for international companies. We explore the indispensable role of the Israeli Representative (IR), who acts as your legal and regulatory liaison on the ground. This episode breaks down the

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01:45

Unlocking the Egyptian MedTech Market: A Pure Global...

MENA MedTech Insights ·

2025/10/11

Egypt is a top-tier market for MedTech expansion in the MENA region, but gaining access requires navigating the complex regulations of the Egyptian Drug Authority (EDA). For foreign manufacturers, the process is filled with unique challenges, from dossier submissions to the critical appointment of a local legal representative. A single misstep can lead to costly delays and missed opportunities in this billion-dollar market.Imagine your innovative diagnostic device has secured CE marking and is

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01:46

Pure Global's Guide to UAE MOHAP Approval: Navigating...

MENA MedTech Insights ·

2025/10/10

The UAE's MedTech market is booming, but a key MOHAP regulation can stop foreign companies in their tracks: the requirement of a local Authorized Representative. Many manufacturers default to appointing their distributor, a decision that can lead to significant business risks and loss of market control.This episode explores the strategic importance of separating your regulatory and commercial functions. We uncover the hidden dangers of tying your device registration to a distributor and lay out

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02:02

MENA MedTech Insights by Pure Global: Mastering Saudi...

MENA MedTech Insights ·

2025/10/09

Saudi Arabia's rapidly expanding MedTech market presents a golden opportunity, but navigating the stringent Saudi Food and Drug Authority (SFDA) regulations is a critical challenge. A successful market entry hinges on one key requirement: appointing a local in-country representative. This episode of MENA MedTech Insights breaks down why this choice is far more than a simple compliance checkbox. We explore the strategic importance of your Authorized Representative and how this decision can either

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03:23

Navigating the MENA Electrophysiology Market: A Guide...

MENA MedTech Insights ·

2025/10/08

In this episode of MENA MedTech Insights, we delve into the booming market for electrophysiology (EP) mapping and ablation systems across the Middle East and North Africa. As nations like Saudi Arabia and the UAE heavily invest in advanced cardiac centers, the demand for cutting-edge MedTech solutions to treat arrhythmias is at an all-time high.We explore the key market drivers, from government initiatives to the rapid adoption of new technologies. We also uncover the critical challenges that many

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02:59

MENA MedTech Insights by Pure Global: Unlocking the...

MENA MedTech Insights ·

2025/10/07

This episode of MENA MedTech Insights dives deep into the burgeoning market for ultrasound imaging equipment in key MENA countries like Saudi Arabia, the UAE, and Egypt. We explore the massive opportunities driven by government initiatives and healthcare modernization.We also uncover the significant and often underestimated regulatory hurdles that can stall market entry. We break down the fragmented landscape, highlighting why a one-size-fits-all approach to regulatory submissions is destined to

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02:57

Navigating the MENA Orthopedic Joint Replacement...

MENA MedTech Insights ·

2025/10/06

The MENA region presents a booming, high-growth opportunity for orthopedic joint replacement manufacturers, but each key market has a unique and complex regulatory maze. From the stringent SFDA in Saudi Arabia to the commercially-focused UAE and the high-volume Egyptian market, a successful launch requires deep, localized expertise. This episode of MENA MedTech Insights provides a practical guide to the regulatory hurdles and strategic pathways for success. We dissect the specific requirements,

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02:19

Navigating Pacemaker & CRM Device Regulations in the...

MENA MedTech Insights ·

2025/10/05

In this episode of MENA MedTech Insights, we delve into the high-stakes world of cardiac rhythm management devices in the Middle East and North Africa. As cardiovascular disease rates climb, we explore the immense opportunities and the daunting regulatory hurdles manufacturers face when trying to enter lucrative markets like Saudi Arabia, the UAE, and Egypt. We uncover the common pitfalls that can delay market entry for months, from documentation mismatches to the critical need for local

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02:57

Unlocking MENA's Billion-Dollar Dialysis Market: A...

MENA MedTech Insights ·

2025/10/04

In this episode of MENA MedTech Insights, we explore the billion-dollar market for hemodialysis and peritoneal dialysis equipment in the Middle East and North Africa. As rates of chronic kidney disease climb, we uncover the immense opportunities for MedTech manufacturers in key markets like Saudi Arabia and the UAE.We break down the complex and fragmented regulatory environment that often creates significant barriers to entry. We discuss why a one-size-fits-all approach to market registration

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02:50

MENA MedTech Insights by Pure Global: Navigating CT...

MENA MedTech Insights ·

2025/10/03

The market for CT imaging systems in the MENA region is booming, fueled by ambitious healthcare projects and substantial government investment. For global MedTech manufacturers, this translates into a massive opportunity. However, the path to market is paved with complex and varied regulatory requirements that can easily derail even the most prepared companies. This episode of MENA MedTech Insights dives deep into the practical challenges and strategic solutions for launching CT scanners in key

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02:43

MENA MedTech Insights: Unlocking the Multi-Million...

MENA MedTech Insights ·

2025/10/02

In this episode of MENA MedTech Insights, we explore the rapidly growing market for MRI scanners across the Middle East and North Africa. As governments in Saudi Arabia, the UAE, and Egypt heavily invest in healthcare infrastructure, the demand for advanced medical imaging technology is soaring. However, tapping into this lucrative market requires navigating a maze of complex and country-specific regulatory requirements that often trap unprepared foreign manufacturers.We uncover the critical

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03:36

Navigating SFDA & MoHAP: Pure Global's Expert Guide...

MENA MedTech Insights ·

2025/10/01

In this episode of MENA MedTech Insights, we explore the booming market for Continuous Glucose Monitoring (CGM) devices across the Middle East and North Africa. Driven by some of the world's highest diabetes rates, countries like Saudi Arabia and the UAE represent a massive opportunity for MedTech manufacturers, but also a significant regulatory challenge.We break down the specific requirements of key health authorities, including the Saudi Food and Drug Authority (SFDA) and the UAE's Ministry of

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02:57

MENA's MedTech Boom: Navigating the Robotic Surgery...

MENA MedTech Insights ·

2025/09/30

This episode of MENA MedTech Insights dives into the booming market for robotic surgical assistance systems in the Middle East and North Africa. We explore the key drivers behind the rapid adoption in countries like the UAE and Saudi Arabia, from government initiatives like Saudi Vision 2030 to the clinical demand for minimally invasive procedures that lead to better patient outcomes.We uncover the real-world application of this technology through a leading case study: American Hospital Dubai's

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03:00

MENA's TAVR Boom: Navigating Saudi & UAE Medical...

MENA MedTech Insights ·

2025/09/29

The market for Transcatheter Heart Valve (TAVR) systems in the MENA region is experiencing unprecedented growth, fueled by healthcare modernization in countries like Saudi Arabia and the UAE. For global MedTech companies, this represents a golden opportunity. However, the path to market access is paved with complex and fragmented regulatory hurdles that can stall even the most innovative products. In this episode, we explore the specific challenges and strategic solutions for launching heart valve

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