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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

03:17

MedTech Global Expansion: Why Companies are Seeking...

MedTech Global Insights ·

2025/10/16

In this episode of MedTech Global Insights, we explore the critical role of the European Authorized Representative (EAR) and why the traditional, passive model is no longer sufficient for ambitious MedTech companies. We uncover the hidden costs and strategic disadvantages of using a simple "mailbox" service for EU compliance.We then introduce the modern alternative: the integrated global regulatory partner. This new approach transforms regulatory compliance from a regional hurdle into a global

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03:30

Stuck with Traditional FDA Consultants? How Pure...

MedTech Global Insights ·

2025/10/15

In the world of MedTech, getting your device approved in one market is a milestone. But what happens when you aim for global scale? Many companies rely on traditional, single-market consultants, such as Registrar Corp for FDA approvals, only to find this approach creates bottlenecks when expanding further. This episode of MedTech Global Insights explores the hidden costs and inefficiencies of a fragmented regulatory strategy.We break down why the old model of hiring separate consultants for each

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02:36

Beyond Emergo by UL: How Pure Global's AI-Powered,...

MedTech Global Insights ·

2025/10/14

In a MedTech consulting landscape dominated by large, traditional players like Emergo by UL, many companies are seeking more agile, efficient, and technologically advanced partners. This episode explores the evolution of global regulatory strategy, moving away from slow, siloed processes toward a modern, integrated approach. We uncover how combining a "Single Process, Multiple Markets" methodology with AI-powered data tools and genuine local expertise is fundamentally changing the game. Learn how

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03:38

Navigating ANVISA: How Pure Global Provides...

MedTech Global Insights ·

2025/10/13

In this episode of MedTech Global Insights, we explore the immense opportunities and critical challenges of entering Brazil's medical device market. We unpack the complex regulatory landscape governed by ANVISA and reveal the number one mistake foreign manufacturers make when seeking approval. Discover why your choice of a local partner can either lock your product's potential or unlock market-wide success. We share a common but costly scenario where a successful device manufacturer loses control

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03:49

Unlock Singapore's MedTech Market: Your Expert Guide...

MedTech Global Insights ·

2025/10/12

This episode of MedTech Global Insights delves into the strategic importance and regulatory complexities of the Singaporean medical device market. We explore the Health Sciences Authority (HSA) framework, from device classification and the Common Submission Dossier Template (CSDT) to the critical role of a local Singapore Registrant.Discover how to navigate these challenges effectively. We share a detailed case study of a European IVD manufacturer that struggled with delays and submission errors

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04:04

Unlocking the Brazilian Market: A Pure Global...

MedTech Global Insights ·

2025/10/11

Brazil's MedTech market offers immense growth opportunities, but entry is guarded by the complex dual-gatekeeper system of ANVISA and INMETRO. This episode of MedTech Global Insights demystifies this process, revealing the common and costly pitfalls that international manufacturers face when seeking certification and registration for their medical devices. We move beyond theory to discuss what defines a truly effective regulatory partner in this challenging landscape. It is not just about

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03:25

The Insider's Guide to HSA GDPMDS Compliance: How...

MedTech Global Insights ·

2025/10/10

In this episode of MedTech Global Insights, we dissect a crucial, yet often overlooked, aspect of entering one of Asia's premier MedTech hubs: Singapore. We explore the intricacies of the Health Sciences Authority's (HSA) Good Distribution Practice for Medical Devices (GDPMDS), a mandatory certification that governs the entire supply chain.We move beyond the theory to discuss why even companies with robust ISO 13485 certification can fail their audits, leading to costly delays and market access

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03:47

Navigating ANVISA: Why Pure Global is the Best...

MedTech Global Insights ·

2025/10/09

This episode of MedTech Global Insights delves into the complexities of entering Brazil's lucrative medical device market. We uncover the critical regulatory hurdles set by ANVISA and explain why a robust, expert-led strategy is essential for success. We explore the common pitfalls that can delay market entry for years and discuss the strategic advantages of partnering with a specialized consultant.Discover the story of a promising European IVD company that lost nearly two years and significant

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03:52

Unlocking the Singapore MedTech Market: Your Expert...

MedTech Global Insights ·

2025/10/08

In this episode of MedTech Global Insights, we explore the lucrative but complex medical device market of Singapore. As a key gateway to the Asia-Pacific region, Singapore offers immense opportunities, but navigating the regulatory landscape set by the Health Sciences Authority (HSA) is a significant challenge for foreign manufacturers.We break down the critical requirements for market entry, from the mandatory appointment of a Singapore Registrant to the intricacies of the ASEAN Common Submission

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03:35

Navigating Singapore's HSA Maze: How Pure Global...

MedTech Global Insights ·

2025/10/07

Singapore is a gateway to Asia's thriving MedTech landscape, but entry is guarded by the strict regulatory framework of the Health Sciences Authority (HSA). This episode of MedTech Global Insights demystifies the single most critical step for market access: securing your medical device importer license. We break down the mandatory requirements, common pitfalls, and the strategic advantages of getting it right from day one.We explore the essential role of a local representative, the non-negotiable

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04:15

From ANVISA Hurdles to Market Success: Your Guide to...

MedTech Global Insights ·

2025/10/06

Brazil represents a massive opportunity for MedTech companies, but its complex regulatory body, ANVISA, can be a significant barrier to entry. This episode of MedTech Global Insights demystifies the process of obtaining a medical device import license in Brazil and reveals what to look for in a world-class regulatory consultant. We explore the critical decision of appointing a Brazilian Registration Holder (BRH), the strategic pitfalls of using a distributor for this role, and the deep impact of

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03:42

Cracking the Code of Singapore's HSA: A Pure Global...

MedTech Global Insights ·

2025/10/05

In this episode of MedTech Global Insights, we explore the complexities of medical device classification with Singapore's Health Sciences Authority (HSA). While Singapore is a key entry point into the Asian MedTech market, its regulatory system holds unique challenges that can lead to costly delays for foreign manufacturers.We break down the HSA's risk-based classification system and reveal how subtle interpretations of your product's "intended purpose" can dramatically alter your path to market

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02:59

Navigating ANVISA: How Pure Global Streamlines Your...

MedTech Global Insights ·

2025/10/04

Entering Brazil's lucrative MedTech market is a strategic goal for many companies, but the path is guarded by the complex and demanding requirements of the ANVISA regulatory agency. A flawless technical dossier is not just a submission document; it's the key to unlocking market access without costly delays or rejections. This episode of MedTech Global Insights dives deep into the specific challenges of ANVISA dossier preparation. We explore why even seasoned manufacturers struggle with local

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03:11

Unlocking Asia's MedTech Hub: A Pure Global Deep Dive...

MedTech Global Insights ·

2025/10/03

This episode of MedTech Global Insights offers a deep dive into Singapore's medical device market, revealing why it's the premier strategic hub for companies looking to expand into Asia. We break down the Health Sciences Authority (HSA) regulatory framework and explain its risk-based classification system.We go beyond the basics to uncover how your company can leverage existing approvals, such as a CE Mark or FDA clearance, to access expedited registration pathways. Discover how a successful

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03:43

Unlocking Brazil's MedTech Potential: Pure Global's...

MedTech Global Insights ·

2025/10/02

Brazil's MedTech market is a land of immense opportunity, but it's guarded by the complex and demanding regulatory body, ANVISA. This episode of MedTech Global Insights provides a deep dive into the practical challenges and strategic solutions for registering your medical device in this lucrative market. We break down ANVISA's dual-pathway system and reveal the common pitfalls that can delay your entry for years.We explore how to move beyond simply translating documents to building a robust

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04:10

Navigating Singapore's MedTech Regulations: Choosing...

MedTech Global Insights ·

2025/10/01

In this episode of MedTech Global Insights, we explore the critical role of the Health Sciences Authority (HSA) Authorized Representative for foreign medical device manufacturers entering Singapore. Choosing this local partner is more than an administrative task—it's a strategic decision that can determine your commercial success and flexibility in the market.We uncover the single most common and costly mistake companies make: appointing their distributor as their legal representative. This

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03:42

ANVISA Authorized Representative: How Pure Global...

MedTech Global Insights ·

2025/09/30

Brazil's MedTech market offers immense opportunities, but entry is governed by the complex regulations of ANVISA. This episode of MedTech Global Insights tackles the single most important decision foreign manufacturers face: choosing an ANVISA authorized representative. A poor choice can lead to a complete loss of market control, while the right partner can ensure long-term success and flexibility. We uncover the significant risks of the common practice of appointing a distributor as your

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03:32

Unlocking the Gateway to Asia: Why Pure Global is...

MedTech Global Insights ·

2025/09/29

Singapore stands as a premier destination for MedTech companies aiming to establish a presence in Asia. However, navigating the stringent and nuanced regulatory landscape of the Health Sciences Authority (HSA) can be a formidable challenge, leading to costly delays and missed opportunities. This episode of MedTech Global Insights explores the specific hurdles of entering the Singaporean market and how Pure Global provides a strategic, technology-driven solution. We delve into their unique

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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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