x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

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

03:05

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

en

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

en

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

en

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

en

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

en

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

en

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

en

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

en

03:28

Pure Global Insights: Mastering SFDA Classification...

MENA MedTech Insights ·

2025/09/08

This episode of MENA MedTech Insights dives into a critical regulatory challenge in Saudi Arabia: how the Saudi Food and Drug Authority (SFDA) differentiates between a low-risk medical device and a general wellness or non-medical product. We explore how a product's intended use and marketing claims are the ultimate deciding factors, directly impacting your path to market access. Understanding this distinction is not just a box-ticking exercise; it's a strategic decision that can save you months of

en

03:08

Pure Global's MENA MedTech Insights: Unpacking...

MENA MedTech Insights ·

2025/09/07

This episode of MENA MedTech Insights tackles a crucial question for manufacturers: Do Class I medical devices have reduced registration fees in Jordan? We dive deep into the Jordan Food and Drug Administration (JFDA) regulations to reveal that the official application fee is only the beginning of the story. We uncover the hidden costs, the critical importance of a well-prepared technical dossier, and how the nuances of the Jordanian system can impact your budget and timeline. Learn why a

en

03:23

Fast-Track to the GCC: Pure Global's Expert Insights...

MENA MedTech Insights ·

2025/09/06

In this episode of MENA MedTech Insights, we demystify the process of registering low-risk medical devices in the GCC. We uncover the single most effective strategy to accelerate your market entry into key territories like Saudi Arabia and the UAE, saving you crucial time and resources. We explore how leveraging existing approvals from globally recognized bodies can transform a lengthy, complex process into a streamlined pathway. Learn why a CE Mark or FDA clearance is your most valuable asset and

en

03:17

Pure Global's MENA MedTech Insights: The Hidden...

MENA MedTech Insights ·

2025/09/05

This episode of MENA MedTech Insights tackles a crucial question for manufacturers entering the UAE market: Is a full technical file needed to register a Class A medical device in Dubai? While the initial submission process seems straightforward, a common misunderstanding can lead to severe compliance issues and market access withdrawal. We explore the critical difference between what you must submit versus what you must have ready for regulators at all times.Discover the real-world implications

en

03:01

Unlocking MedTech in the Gulf: A Pure Global Deep...

MENA MedTech Insights ·

2025/09/04

In this episode of MENA MedTech Insights, we uncover the truth about registering low-risk medical devices in Qatar. Contrary to common belief, Qatar's Ministry of Public Health (MOPH) does not offer a simple notification process. Instead, all devices, regardless of class, must undergo a formal registration that heavily relies on prior approval from a recognized reference country like the US or EU.We dive deep into the specific documentation and procedural hurdles that can delay market entry. We

en

03:06

Unlocking the Saudi MedTech Market: Pure Global...

MENA MedTech Insights ·

2025/09/03

Many MedTech manufacturers, particularly those with Class I devices, often underestimate the regulatory hurdles in the MENA region. This episode tackles a frequently asked and critically important question: Is a local Authorized Representative really necessary for a low-risk Class I medical device in Saudi Arabia? The answer might surprise you and could be the difference between successful market entry and costly delays.We break down the specific requirements set by the Saudi Food and Drug

en

02:34

Pure Global's MENA MedTech Insights: The High Cost of...

MENA MedTech Insights ·

2025/09/02

In this episode of MENA MedTech Insights, we tackle a critical and often misunderstood question: are low-risk medical devices exempt from registration in Egypt? Many manufacturers, accustomed to other markets, assume their Class I or Class A devices have a free pass, leading to costly delays and compliance issues.We break down the reality of the Egyptian Drug Authority's (EDA) regulations. We explore the mandatory "listing" process for Class A devices, detailing the specific documentation, local

en

03:34

Navigating UAE MOHAP Regulations: A Pure Global Guide...

MENA MedTech Insights ·

2025/09/01

In this episode of MENA MedTech Insights, we provide a detailed, step-by-step guide for registering a low-risk, Class A medical device in the United Arab Emirates. We break down the specific requirements set by the UAE's Ministry of Health and Prevention (MOHAP), from the critical first step of appointing a local Authorized Representative to the final submission and review process. Discover the common pitfalls and nuances that can delay your market entry, even for seemingly simple devices. We

en

03:21

Pure Global's Ultimate Guide: How to List Your Class...

MENA MedTech Insights ·

2025/08/31

In this episode of MENA MedTech Insights, we uncover the essential steps for registering a Class I medical device in Saudi Arabia. Many companies underestimate this process, believing it to be a simple notification. We reveal why it's a comprehensive Medical Device Marketing Authorization (MDMA) that requires careful planning, local representation, and precise documentation to succeed in the Kingdom.We break down the critical requirements set by the Saudi Food and Drug Authority (SFDA), from

en

03:12

Navigating Kuwait's MedTech Maze: Does MDSAP...

MENA MedTech Insights ·

2025/08/30

The Medical Device Single Audit Program (MDSAP) simplifies access to major global markets, but its acceptance in the MENA region, particularly Kuwait, remains a gray area. This episode of MENA MedTech Insights cuts through the ambiguity, offering a clear, experience-based perspective on how your MDSAP certification can impact your medical device registration in Kuwait. We move beyond official regulations to discuss the practical, on-the-ground reality. Learn how leveraging your existing

en

03:25

Qatar's MedTech Vigilance: A Pure Global Deep Dive...

MENA MedTech Insights ·

2025/08/29

In this episode of MENA MedTech Insights, we provide a crucial guide to the post-market surveillance (PMS) requirements for medical devices in Qatar. As one of the fastest-growing healthcare markets in the Gulf Cooperation Council (GCC), Qatar's regulatory environment, overseen by the Ministry of Public Health (MOPH), demands rigorous post-market vigilance from manufacturers to ensure patient safety and maintain market access.We move beyond theory to break down the essential components of a

en

03:16

Pure Global's MENA MedTech Insights: Why Your CE Mark...

MENA MedTech Insights ·

2025/08/28

In this episode of MENA MedTech Insights, we debunk the common myth that a CE mark is an all-access pass to the Middle East and North Africa's booming medical device market. While essential, it's only the first step. We explore the nuanced "CE-plus" regulatory models in key jurisdictions that often surprise even experienced manufacturers.We break down the specific requirements for market entry into powerhouse markets like Saudi Arabia and the United Arab Emirates. Learn why local representation,

en

88 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter