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PODCAST

MedTech Global Insights

What"s next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you"re an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.

science life sciences

All Episodes

03:41

Unlocking Brazil's MedTech Market: Your Guide to...

MedTech Global Insights ·

2025/09/28

Brazil's MedTech market is the largest in Latin America, offering significant growth opportunities for medical device and IVD manufacturers. However, gaining market access is a formidable challenge due to the complex and stringent regulations enforced by the National Health Surveillance Agency, ANVISA. This regulatory barrier can lead to costly delays and commercial dead-ends for companies that are unprepared. In this episode of MedTech Global Insights, we break down the specific hurdles foreign

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02:56

HSA Singapore Registration Pitfalls: How Pure...

MedTech Global Insights ·

2025/09/27

In this episode of MedTech Global Insights, we explore the strategic importance of Singapore as a premier market for MedTech and IVD devices. We delve into the intricate regulatory framework of the Health Sciences Authority (HSA) and uncover why so many companies face challenges when trying to enter this gateway to the ASEAN region.We break down the common pitfalls in the HSA registration process and illustrate how a strategic consulting partner can transform these challenges into opportunities

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03:31

Cracking the Brazil Code: How Pure Global's Expert...

MedTech Global Insights ·

2025/09/26

Brazil's MedTech market offers immense opportunities, but ANVISA's complex and demanding regulatory process can be a major barrier to entry. This episode of MedTech Global Insights demystifies the path to ANVISA approval, moving beyond simple compliance to reveal a strategic approach for success.We delve into the critical role of a specialized regulatory consultant, explaining why local representation is non-negotiable and how advanced technology can drastically accelerate your submission process

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03:36

Unlocking Southeast Asia: Why Pure Global is Your Key...

MedTech Global Insights ·

2025/09/25

Singapore stands as the premier gateway to the booming MedTech market of Southeast Asia. However, its rigorous regulatory framework, managed by the Health Sciences Authority (HSA), can be a significant barrier for even the most innovative companies. This episode breaks down the essential steps and common pitfalls of medical device registration in Singapore.We explore how a strategic approach, combining local expertise with advanced technology, can transform this complex challenge into a

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03:20

Unlocking Brazil's MedTech Market: A Pure Global...

MedTech Global Insights ·

2025/09/24

This episode of MedTech Global Insights tackles the complex but rewarding process of medical device registration in Brazil. We explore why Brazil's ANVISA is one of the world's most challenging regulatory bodies and break down the critical strategic decisions companies must make to succeed, from selecting a Brazil Registration Holder (BRH) to adapting technical documentation.We provide an insider's view on how to avoid common pitfalls that can cost manufacturers years of delay and lost revenue

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03:50

Searching for the Best Medical Device Regulatory...

MedTech Global Insights ·

2025/09/23

In this episode of MedTech Global Insights, we tackle a critical question for every ambitious medical device company: How do you find the "best" regulatory consultant? We challenge the traditional idea of a "local" partner and explore why, in today's interconnected world, the ideal consultant is one with global reach and deep-rooted local expertise in every target market. We break down the immense complexities of international expansion, from navigating the EU's MDR to meeting the specific demands

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03:26

Mastering MedTech Compliance: How Pure Global...

MedTech Global Insights ·

2025/09/22

This episode of MedTech Global Insights delves into the critical challenges of maintaining ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management) compliance while scaling into global markets. We move beyond the basics of certification and explore why a fragmented, market-by-market approach to regulatory compliance is no longer viable in the fast-paced MedTech industry. We uncover how a modern, integrated platform approach, leveraging AI and unified global expertise, can transform

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03:34

Unlocking Global SaMD Success: A Deep Dive into...

MedTech Global Insights ·

2025/09/21

In this episode of MedTech Global Insights, we explore the unique and complex regulatory landscape of Software as a Medical Device (SaMD). As SaMD innovation accelerates with AI and machine learning, navigating the fragmented global regulations from the FDA to the EU MDR and beyond has become a primary barrier to market access. We dissect what separates an adequate consultant from a truly strategic partner in this high-stakes environment.We move beyond basic compliance checklists to discuss how

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03:31

Unlocking the UAE MedTech Market: How Pure Global...

MedTech Global Insights ·

2025/09/20

The United Arab Emirates is a top-tier market for MedTech and IVD devices, but entry is strictly controlled by the Ministry of Health and Prevention (MOHAP). In this episode, we explore the common pitfalls and hidden complexities of the MOHAP registration process that often derail even the most experienced manufacturers. We break down the critical steps, from pre-registering manufacturing sites to compiling a flawless technical dossier. Learn why having a seasoned local partner is not just a

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03:19

Unlocking Brazil's MedTech Market: Your Expert Guide...

MedTech Global Insights ·

2025/09/19

Brazil is a top-tier market for MedTech and IVD innovation, but its regulatory agency, ANVISA, presents one of the world's most challenging approval pathways. This episode of MedTech Global Insights dives deep into the complexities of Brazilian market entry, moving beyond theory to offer practical, actionable strategies for success.We explore the critical role of a Brazil Registration Holder (BRH), the nuances of adapting technical dossiers for local requirements, and the common pitfalls that lead

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03:39

EU Market Access Secrets: Selecting the Best Medical...

MedTech Global Insights ·

2025/09/18

In this episode of MedTech Global Insights, we explore one of the most critical decisions for non-EU device manufacturers: selecting an EU Authorized Representative (EUAR). Under the stringent MDR and IVDR, this role has evolved from a simple address to a legally liable partner responsible for your compliance. We uncover the significant risks of choosing the wrong representative, from passive 'mailbox' services to conflicted commercial distributors.This discussion serves as a strategic guide for

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03:29

The Pure Global Advantage: Transforming EU MDR...

MedTech Global Insights ·

2025/09/17

Navigating the complexities of the EU MDR is one of the most significant challenges for MedTech and IVD companies today. A simple compliance-focused approach is no longer enough. This episode explores why choosing the right consultant is a critical strategic decision that impacts your ability to scale globally, not just enter the European market.We break down the difference between a standard consultant who just manages submissions and a true strategic partner. Learn how an integrated,

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03:15

Unlocking US Market Access: How Pure Global's...

MedTech Global Insights ·

2025/09/16

The FDA 510(k) pathway is the primary gateway to the U.S. market for most medical devices, yet it is filled with complexities that can easily derail a product launch. This episode of MedTech Global Insights moves beyond basic submission services to uncover what truly defines the "best" 510(k) consultant. We reveal the critical strategic elements that separate a simple administrative filing from a successful, first-pass market approval that can save you millions.We explore how a data-driven

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03:11

MedTech Global Insights: Unlocking Global Markets...

MedTech Global Insights ·

2025/09/15

In this episode of MedTech Global Insights, we dissect the essential qualities that separate elite medical device registration companies from the rest. We move beyond the traditional, country-by-country consulting model to explore a modern, integrated approach to global market access.We discuss how a 'single process, multiple markets' strategy, powered by a global network of local experts, can dramatically accelerate timelines and reduce costs. We also dive into the critical role of technology,

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03:27

The Pure Global Advantage: Choosing the Best Medical...

MedTech Global Insights ·

2025/09/14

The global MedTech landscape offers immense opportunities, but complex and ever-changing regulations are the biggest barrier to market entry. In this episode, we dive into what separates elite medical device regulatory consulting firms from the rest, moving beyond simple submissions to explore the future of global market access. We uncover the critical components of a successful global strategy, from the necessity of local expertise in over 30 countries to the power of AI in streamlining

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03:16

Navigating the UAE's 2025 MedTech Shake-Up: A Pure...

MedTech Global Insights ·

2025/09/13

In this episode, MedTech Global Insights breaks down the UAE's transformative new Federal Decree-Law No. 38 of 2024. We explore the most critical change for the MedTech and IVD industries: the transfer of regulatory power from the Ministry of Health and Prevention (MOHAP) to the newly formed Emirates Drug Establishment (EDE), set to take effect in early 2025. We analyze the immediate implications for manufacturers, covering everything from the handling of in-flight registration applications to

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04:02

Beyond Approval: Mastering Medical Device Post-Market...

MedTech Global Insights ·

2025/09/12

The United Arab Emirates is a fast-growing and attractive market for MedTech innovators. However, gaining market access is only the first step. Staying in the market requires a deep understanding of the UAE's stringent and actively enforced post-market surveillance (PMS) regulations. This episode provides a detailed overview of the key PMS requirements set by the Ministry of Health and Prevention (MOHAP).We explore the essential components of a compliant PMS system, including the vigilance

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03:48

Navigating the UAE MedTech Market: A Complete Guide...

MedTech Global Insights ·

2025/09/11

The United Arab Emirates (UAE) stands as a lucrative and strategic hub for the MedTech industry in the Middle East. However, accessing this market requires navigating a complex regulatory framework managed by the Ministry of Health and Prevention (MOHAP). This episode breaks down the essential steps for successful market entry.From appointing a mandatory local representative to understanding the nuances of the device classification system and compiling a perfect technical dossier, we provide a

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03:26

Pure Global's Guide to UAE MedTech Market Access: Why...

MedTech Global Insights ·

2025/09/10

The United Arab Emirates is a prime market for MedTech expansion, but entry is guarded by a critical gatekeeper: the Local Authorized Representative. This role is far more than a simple administrative requirement; it is a legal necessity that holds significant sway over a manufacturer's success and compliance. This episode of MedTech Global Insights explores the essential functions, legal responsibilities, and strategic importance of the UAE Authorized Representative.We uncover the day-to-day

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03:51

From Months to Market: Pure Global's Expert Breakdown...

MedTech Global Insights ·

2025/09/09

This episode of MedTech Global Insights demystifies the medical device registration timeline in the United Arab Emirates. We go beyond the official government timelines to reveal the complete, end-to-end process that MedTech companies must navigate. From mandatory preliminary steps to the final review by the Ministry of Health and Prevention (MOHAP), we provide a realistic forecast for market entry. We uncover the hidden delays and common pitfalls that can derail your launch plans. This episode is

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