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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

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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03:05

Unlocking the UAE Market for AI MedTech: A Pure...

MENA MedTech Insights ·

2025/09/16

The United Arab Emirates is a key strategic market for innovative AI-powered medical devices. However, many international manufacturers make a costly assumption: that their FDA clearance or European CE mark will grant them immediate access. The reality is that the UAE's regulatory framework, while recognizing these approvals, has its own distinct and mandatory registration process that can lead to significant delays and unforeseen costs if not navigated correctly.Imagine launching your

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03:06

Navigating KSA's Digital Health Frontier: A Pure...

MENA MedTech Insights ·

2025/09/15

This episode of MENA MedTech Insights dives into a crucial regulatory hurdle for digital health companies: the requirement for a Medical Device Marketing Authorization (MDMA) for Software as a Medical Device (SaMD) in the Kingdom of Saudi Arabia (KSA). We break down why the Saudi Food and Drug Authority (SFDA) treats software as a regulated device and what this means for your market entry strategy. We explore the entire process, from understanding the risk-based classification system to the

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03:22

From Code to Compliance: Pure Global's Expert Guide...

MENA MedTech Insights ·

2025/09/14

As Saudi Arabia's healthcare market rapidly digitalizes under Vision 2030, understanding the regulatory landscape for Software as a Medical Device (SaMD) is crucial for innovators. This episode provides a deep dive into the Saudi Food and Drug Authority (SFDA) and its risk-based classification system that governs SaMD market access. We break down the four distinct risk classes—from low-risk data storage apps to high-risk life-support algorithms. Discover why the 'intended use' of your software, not

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02:47

Decoding AMAR with Pure Global: Israel's...

MENA MedTech Insights ·

2025/09/13

In this episode of MENA MedTech Insights, we explore the cutting-edge regulatory landscape of Israel. As a global leader in medical innovation, Israel's approach to regulating adaptive AI and machine learning devices offers a glimpse into the future. We unpack how the Israeli regulatory body, AMAR, moves beyond traditional, static approval models to embrace the dynamic nature of AI.We break down the core components of Israel's framework, focusing on the pivotal role of the Predetermined Change

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03:30

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

MENA MedTech Insights ·

2025/09/12

This episode of MENA MedTech Insights explores the critical cybersecurity and data privacy regulations that medical device manufacturers must navigate to enter the booming UAE market. We break down the key laws, including the Personal Data Protection Law (PDPL) and the impactful ICT Health Law, focusing on its strict data localization requirements.We discuss the practical challenges these regulations pose, from data storage to cybersecurity protocols, and explain what UAE health authorities expect

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03:26

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

MENA MedTech Insights ·

2025/09/11

In this episode of MENA MedTech Insights, we dive into one of the most pressing regulatory questions for digital health innovators targeting Saudi Arabia: Are local clinical trials mandatory for AI medical imaging software? We unpack the Saudi Food and Drug Authority's (SFDA) nuanced position, moving beyond a simple "yes" or "no" to explore the critical importance of population-specific data.We explore why a CE mark or FDA approval might not be enough for market access in the Kingdom. The

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03:33

Pure Global's Ultimate Guide to UAE MOHAP: How to...

MENA MedTech Insights ·

2025/09/10

Thinking of launching your Software as a Medical Device (SaMD) in the United Arab Emirates? The path to approval from the Ministry of Health and Prevention (MOHAP) is filled with unique challenges specific to the MENA region. This episode of MENA MedTech Insights breaks down the essential steps, common pitfalls, and insider strategies for a successful SaMD registration in the UAE, one of the most dynamic markets in the Middle East.We explore a real-world scenario where a promising AI diagnostic

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03:36

MENA MedTech Deep Dive with Pure Global: Unlocking...

MENA MedTech Insights ·

2025/09/09

Saudi Arabia's Vision 2030 has created a surge of opportunity for digital health and AI-driven medical devices. However, the Saudi Food and Drug Authority (SFDA) maintains one of the region's most rigorous regulatory frameworks. This episode provides a detailed walkthrough of the SFDA's requirements for Software as a Medical Device (SaMD) and AI-based technologies, focusing on the practical challenges and strategic steps manufacturers must take to gain market access.We break down the critical

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