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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

03:28

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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,

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03:01

Pure Global's MENA MedTech Insights: A Step-by-Step...

MENA MedTech Insights ·

2025/08/27

This episode of MENA MedTech Insights provides a detailed guide to registering a Class II medical device in Jordan. We explore the critical role of the Jordan Food and Drug Administration (JFDA) and break down the essential steps for foreign manufacturers, from appointing a local representative to compiling a compliant technical dossier.We delve into the specific documentation required, including the importance of prior approval from reference markets like the EU or USA. Learn about common

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03:22

Beyond the Fees: Pure Global Reveals the True Cost of...

MENA MedTech Insights ·

2025/08/26

This episode of MENA MedTech Insights dives deep into the true cost of medical device registration in the GCC, moving beyond the well-known government fees. We uncover the various hidden expenses that can surprise manufacturers, including mandatory local representation, document translation, and embassy legalization costs, providing a realistic financial picture for entering key markets like Saudi Arabia and the UAE.Imagine a European stent manufacturer budgeting $4,000 for SFDA fees in Saudi

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02:36

Pure Global Presents: Decoding Egypt's Arabic...

MENA MedTech Insights ·

2025/08/25

This episode of MENA MedTech Insights dives deep into a crucial, and often underestimated, aspect of entering the Egyptian medical device market: the strict Arabic labeling requirements set by the Egyptian Drug Authority (EDA). We explore the dual-language mandate and uncover the common pitfalls that can lead to significant delays and financial losses for manufacturers. Imagine your company has spent millions on product development and is ready to launch in Egypt, a key MENA market. Your shipment

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03:10

Pure Global MENA MedTech Insights: Choosing Your...

MENA MedTech Insights ·

2025/08/24

In this episode of MENA MedTech Insights, we tackle a critical strategic decision for any medical device manufacturer looking to enter the Kingdom of Saudi Arabia: choosing your Authorized Representative (AR). This SFDA requirement is more than a formality; it's a choice that can define your operational freedom and long-term success in the market. We explore the two main pathways: appointing your distributor versus partnering with an independent, third-party AR. While naming your distributor seems

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03:15

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

MENA MedTech Insights ·

2025/08/23

This episode of MENA MedTech Insights dives deep into the complex world of medical device classification across the Middle East and North Africa. We move beyond the basics of risk-based classes to uncover the single most important factor for market access: reference country approvals. Learn how regulators in key markets like Saudi Arabia and the United Arab Emirates leverage prior approvals from the FDA, EU, and others to shape their registration pathways. We break down the specific requirements

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03:27

Pure Global's Expert Guide to UAE Medical Device...

MENA MedTech Insights ·

2025/08/22

The UAE boasts one of the most advanced healthcare systems in the MENA region, but accessing this lucrative market requires a deep understanding of the Ministry of Health and Prevention (MOHAP) regulations. This episode provides a practical, step-by-step guide for MedTech manufacturers aiming for successful market entry, transforming complex regulatory hurdles into a clear path to approval. We break down the entire process, from the non-negotiable first step of appointing a local Authorized

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03:01

Cracking the Code: A Pure Global Playbook for SFDA...

MENA MedTech Insights ·

2025/08/21

This episode of MENA MedTech Insights dives deep into the specific requirements for medical device registration with the Saudi Food and Drug Authority (SFDA). We uncover the critical steps and common pitfalls foreign manufacturers face when trying to enter one of the largest and fastest-growing healthcare markets in the Middle East. We explore why your choice of a local Authorized Representative can make or break your market entry strategy and how leveraging existing approvals from bodies like the

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02:45

Cracking the Saudi Arabia MedTech Market: A Pure...

MENA MedTech Insights ·

2025/08/19

In this episode of MENA MedTech Insights, we demystify the process of medical device registration in Saudi Arabia. We explore why the Saudi Food and Drug Authority (SFDA) is a critical gatekeeper to one of the fastest-growing healthcare markets and break down the common hurdles that international manufacturers face.We move beyond the basics of GHTF prerequisites and dive into the specific nuances of the SFDA's requirements. Learn why your CE Mark or FDA clearance is only the beginning of the journey

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