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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

02:57

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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03:23

MENA MedTech Market Deep Dive: How Pure Global Helps...

MENA MedTech Insights ·

2025/09/28

The United Arab Emirates is a cornerstone of the MENA MedTech market, but gaining access requires mastering its specific clinical trial regulations. As the UAE's Ministry of Health and Prevention (MOHAP) enhances its regulatory framework, understanding the precise requirements for medical device investigations is more critical than ever for international manufacturers.This episode provides a detailed breakdown of the UAE's clinical trial approval process. We explore the non-negotiable first step

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03:30

Navigating SFDA's MDS-G35: A Pure Global Deep Dive...

MENA MedTech Insights ·

2025/09/27

Maintaining market access in Saudi Arabia is even more challenging than gaining initial approval. The SFDA's post-market surveillance (PMS) requirements are rigorous and demand a proactive, systemic approach. Many international manufacturers are caught off guard by the depth of these expectations, risking compliance actions that could jeopardize their presence in one of the largest MedTech markets in the MENA region. This episode of MENA MedTech Insights provides a deep dive into the SFDA’s core

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03:25

Cracking Jordan's MedTech Market: A Pure Global Deep...

MENA MedTech Insights ·

2025/09/26

This episode of MENA MedTech Insights tackles one of the most significant hurdles for device manufacturers entering Jordan: the Legalized Free Sale Certificate (FSC). We demystify the stringent requirements set by Jordan's JFDA under Law 21 of 2014, moving beyond the basics to uncover the specific, multi-step legalization process that trips up even experienced companies.We explore why a simple certificate of free sale isn't enough and detail the precise chain of authentication required, from your

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03:14

Unlocking the Israeli MedTech Market: Pure Global's...

MENA MedTech Insights ·

2025/09/25

In this episode of MENA MedTech Insights, we demystify the process of registering medical devices in Israel. We explore the strategic advantages of the AMAR Medical Device Law of 2012, which leverages prior approvals from recognized countries like the U.S. and the E.U. to create a streamlined market-entry pathway.This episode breaks down the essential, non-negotiable role of the Israel Registration Holder (IRH). We explain why foreign manufacturers cannot go it alone and how a local expert is the

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03:20

Cracking the Code of Egypt's EDA Decree 892/2022: A...

MENA MedTech Insights ·

2025/09/24

This episode of MENA MedTech Insights unpacks the transformative impact of the Egyptian Drug Authority's (EDA) Decree 892/2022 on medical device registration. We explore the critical changes manufacturers must understand to successfully navigate one of the region's most important healthcare markets.From the alignment of risk classifications with global standards to new, stringent requirements for technical documentation and post-market surveillance, this decree represents a major regulatory

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02:54

Pure Global's Guide to UAE MedTech Marketing: A Deep...

MENA MedTech Insights ·

2025/09/23

In this episode of MENA MedTech Insights, we take a deep dive into the United Arab Emirates' stringent regulations for medical device advertising. We unpack the essential framework established by the Ministry of Health and Prevention's (MoHAP) Circular No. 23 of 2020, a critical piece of legislation for any MedTech company operating in or entering the lucrative UAE market.We move beyond the text of the law to discuss its real-world impact. Learn about the absolute necessity of pre-approval for all

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03:12

Unlock the UAE MedTech Market: Pure Global's Expert...

MENA MedTech Insights ·

2025/09/22

In this episode of MENA MedTech Insights, we dissect the UAE's transformative Cabinet Decision No. 58 of 2022. This new regulation is a critical hurdle for any MedTech or IVD company looking to enter or remain in this key Middle Eastern market. We provide a clear, actionable breakdown of the most significant changes you need to be aware of. We explore the three core pillars of the new legislation: the mandatory implementation of the Unique Device Identification (UDI) system, the heightened

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03:17

Navigating SFDA's UDI Maze: A Pure Global Guide to...

MENA MedTech Insights ·

2025/09/21

In this episode of MENA MedTech Insights, we provide a deep dive into the Saudi Food and Drug Authority's (SFDA) Unique Device Identification (UDI) system. We explore the critical requirements of guidance MDS-G34, a non-negotiable for medical technology companies operating in Saudi Arabia, a key market in the Middle East. Understanding this framework is essential for ensuring device traceability, patient safety, and uninterrupted market access. We break down the core components of the SFDA UDI,

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03:04

Pure Global's Expert Guide to Saudi Arabia's MDMA:...

MENA MedTech Insights ·

2025/09/20

This episode of MENA MedTech Insights dives deep into the Saudi Arabian medical device market, focusing on the most critical pathway for international manufacturers: obtaining a Medical Device Marketing Authorization (MDMA) through the SFDA's Interim Regulation. We unravel the process, clarifying how leveraging approvals from key global markets can fast-track your entry into this lucrative region.Imagine you have a CE-marked or FDA-approved device, ready for the booming Saudi market. You assume

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03:17

Cracking the Code to Saudi Arabia's MedTech Market: A...

MENA MedTech Insights ·

2025/09/19

This episode of MENA MedTech Insights offers a deep dive into the technical documentation required by the Saudi Food and Drug Authority's (SFDA) MDS-G5 guidance. We break down the critical components of a successful technical file submission, from device descriptions and risk management to clinical evaluation reports, for MedTech and IVD companies targeting the Saudi Arabian market.We explore the common pitfalls that can lead to significant delays and rejections. For instance, a promising MedTech

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03:38

Navigating SFDA's AI Maze: Pure Global's Expert...

MENA MedTech Insights ·

2025/09/18

In this episode of MENA MedTech Insights, we delve into a critical challenge for innovators: how to manage updates for AI-powered medical software that is already registered with the Saudi Food and Drug Authority (SFDA). The iterative nature of AI development clashes with rigid regulatory frameworks, creating a significant hurdle for manufacturers.We break down the SFDA's risk-based approach, exploring the crucial difference between a 'substantial' and 'non-substantial' change. Understanding this

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03:15

Unlocking the Saudi Market for Your SaMD: A Pure...

MENA MedTech Insights ·

2025/09/17

This episode delves into the essential requirements for appointing a Saudi Arabian Authorized Representative (AR) for Software as a Medical Device (SaMD) products, as mandated by the Saudi Food and Drug Authority (SFDA). We explore why a specialized, SFDA-licensed AR is not just a regulatory hurdle but a critical partner for ensuring successful market entry and ongoing compliance in the Kingdom.We unpack the specific responsibilities of an AR for SaMD, from navigating the intricacies of software

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