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PODCAST

Medical Device Global Market Access

Navigate every market. Accelerate every launch. Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut. Why listen? • Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other

technology

All Episodes

03:41

Regulatory Foresight: A Blueprint for Global MedTech...

Medical Device Global Market Access ·

2025/09/27

This episode provides MedTech innovators with a foundational blueprint for embedding a global regulatory strategy into their product development process from the very beginning. We explore why a reactive, market-by-market approach fails and outline the critical early-stage decisions in market selection, quality management, and clinical evidence that pave the way for faster, more efficient international market access.Key Questions: • Why is a 'launch and learn' regulatory approach so risky for new

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03:31

Local Reps, Global Reach: The Unseen Gatekeepers of...

Medical Device Global Market Access ·

2025/09/26

This episode explores the critical, often mandatory, role of in-country representatives for medical device manufacturers entering foreign markets. We cover their functions from initial product registration and labeling to post-market vigilance and adverse event reporting. The episode also highlights the strategic pitfalls of using a distributor as a representative and the benefits of appointing an independent professional to maintain control and flexibility.• What is an in-country representative

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02:40

UAE MedTech Approval: Decoding the MOHAP Process

Medical Device Global Market Access ·

2025/09/25

This episode demystifies the medical device approval process in the United Arab Emirates. We explain the central role of the Ministry of Health and Prevention (MOHAP), the mandatory manufacturer registration, and how the formal risk-based classification system (Classes I-IV) dictates your entire path to market, from evidence requirements to review timelines.Key Questions: • Who is the single regulatory authority for medical devices in the UAE? • What is the first step a manufacturer must take

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02:46

UAE MedTech Approval: Your MOHAP Dossier and...

Medical Device Global Market Access ·

2025/09/25

This episode breaks down the essential documentation required for medical device registration with the UAE's Ministry of Health and Prevention (MOHAP). We explore the complete technical dossier, from the Free Sale Certificate and ISO 13485 to bilingual labeling and clinical data. A key focus is clarifying the "simplified pathway" for devices with prior CE or FDA approval, explaining how it impacts the review process without reducing the amount of paperwork required for a successful submission. Key

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03:07

The Gatekeeper: Unlocking the UAE MedTech Market with...

Medical Device Global Market Access ·

2025/09/25

This episode delves into the mandatory requirement for a Local Authorized Representative (LAR) when bringing a medical device to the United Arab Emirates market. We explore the critical functions of the LAR as the interface with the Ministry of Health and Prevention (MOHAP), their legal responsibilities for product registration and post-market vigilance, and the strategic importance of selecting an independent representative over a commercial distributor. Key Questions: • Is a local representative

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02:39

UAE Regulatory Overhaul: Unpacking Federal Decree-Law...

Medical Device Global Market Access ·

2025/09/24

This episode delves into the landmark changes introduced by the UAE's Federal Decree-Law 38 of 2024, which took effect on January 2, 2025. We explore the creation of the new Emirates Drug Establishment (EDE), the critical new requirements for importers and distributors, and what the one-year grace period means for medical device manufacturers looking to enter or remain in the UAE market.• What is the new Federal Decree-Law 38 of 2024 and when does it become effective? • How does the new Emirates

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02:44

UAE MedTech Market Entry: A Guide to Timelines and Costs

Medical Device Global Market Access ·

2025/09/23

This episode provides a detailed breakdown of the timelines and costs associated with registering a medical device in the United Arab Emirates. We explore the two main regulatory pathways, the specific government fees in AED, and the often-overlooked indirect costs like translation and notarization that manufacturers must budget for. We also break down the review timelines based on MOHAP’s risk classification system.Key Questions: • What is the first step for any manufacturer entering the UAE

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03:03

Distributor Contracts: Your Performance Shield or a...

Medical Device Global Market Access ·

2025/09/22

This episode dives into the critical components of medical device distributor agreements that protect manufacturers from underperformance. We explore how to structure contracts with specific Key Performance Indicators (KPIs) and robust termination clauses, turning your agreement into a tool for accountability and market success, rather than a liability. • How can an exclusive distributor agreement backfire and trap your product? • What are the most effective KPIs to include beyond simple sales

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03:04

Beyond the Sale: The Critical Role of MedTech Service...

Medical Device Global Market Access ·

2025/09/22

A successful product launch goes far beyond the initial sale. For manufacturers of high-complexity analyzers and consumables, the true test of a distribution partner lies in their logistical prowess and service support infrastructure. This episode explores the essential, non-negotiable support functions that ensure your device not only reaches the customer but operates reliably to meet the demanding uptime requirements of modern clinical laboratories. Key Questions: • Does your distribution

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02:55

U.S. Agent vs. Initial Importer: A Critical Choice...

Medical Device Global Market Access ·

2025/09/21

This episode demystifies the distinct and critical roles of the FDA U.S. Agent and the Initial Importer for medical device manufacturers entering the U.S. market. We explore the specific regulatory responsibilities of each, highlighting why appointing a distributor without proven compliance expertise can jeopardize your import success and post-market standing. • What is the fundamental difference between an FDA U.S. Agent and an Initial Importer? • Who is legally responsible for reporting adverse

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03:11

The Distributor Mismatch: Finding Your IVD's Champion...

Medical Device Global Market Access ·

2025/09/20

Choosing the right U.S. distributor is a make-or-break decision for IVD manufacturers. This episode moves beyond big names to focus on the critical importance of aligning with a distributor's specific customer focus and sales structure. We explore why understanding "call points"—whether in hospital labs, reference labs, or physician offices—and ensuring a distributor will dedicate resources to champion your new device are non-negotiable steps for a successful market launch.• What are "call points"

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03:14

From Code to Cash: A Guide to U.S. Medical Device...

Medical Device Global Market Access ·

2025/09/19

Securing a U.S. medical device code is only half the battle; the next challenge is determining its payment rate. This episode breaks down the three primary pathways for setting reimbursement rates in the United States. We explore the roles of CMS and private payers, detailing the specifics of the cross-walking and gap-filling processes, including key timelines like the annual summer public meetings. We also uncover the most common pitfalls that can delay or diminish your device's earning potential,

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02:54

Beyond the Box: How Distributor Contracts Drive...

Medical Device Global Market Access ·

2025/09/18

Securing shelf space is just the beginning; ensuring your medical device is billable is the key to commercial success. This episode explores the crucial role a distributor plays in navigating the complex reimbursement landscape. We discuss how a strategic partner’s “contracting muscle” can manage interim billing codes, overcome Medicare edits, and leverage powerful GPO contracts to accelerate market adoption and ensure your innovation gets paid.Key Questions: • Why is a distributor’s reimbursement

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03:04

MedTech's Last Mile: Ensuring Uptime with Superior...

Medical Device Global Market Access ·

2025/09/18

Beyond regulatory approval, the success of high-complexity medical devices hinges on a robust support infrastructure. This episode explores the critical, often-overlooked challenges of logistics, installation, and service. We delve into why cold-chain management, on-site validation, and 24/7 technical support are non-negotiable for devices like advanced analyzers and their sensitive consumables, particularly in meeting stringent lab requirements. Key Questions: • What are the hidden logistical

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03:18

FDA Import Readiness: U.S. Agent vs. Initial Importer...

Medical Device Global Market Access ·

2025/09/18

Navigating the FDA's import regulations requires a clear understanding of two critical, yet distinct, roles: the U.S. Agent and the Initial Importer. This episode breaks down their specific responsibilities, explaining how confusing them can lead to costly customs delays and compliance failures. We explore the specific regulatory burdens of the Initial Importer, including Medical Device Reporting and device listing, and highlight why manufacturers must verify their distributor’s capabilities to

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03:09

Beyond the Handshake: Structuring MedTech Distributor...

Medical Device Global Market Access ·

2025/09/17

Granting distributor exclusivity can be a powerful market entry tool, but it carries significant risks if not managed correctly. This episode explores how to structure robust distribution agreements by embedding specific Key Performance Indicators (KPIs) and strategic termination clauses to ensure accountability and protect your interests. We delve into the essential metrics and contractual safeguards that can make the difference between a thriving partnership and a costly mistake.• Is an

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03:16

Unlock the US IVD Market: Finding the Right...

Medical Device Global Market Access ·

2025/09/16

Choosing the right U.S. distributor is a make-or-break decision for IVD manufacturers. This episode explores why customer fit and sales focus are more critical than size. We dissect the importance of matching a distributor’s call-points—be it hospital labs, reference labs, or physician offices—to your specific device and how to ensure your product becomes a priority for their sales team, rather than getting lost in a crowded catalog.• Why is a distributor's existing customer base the most

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03:19

Cracking the Code: IVD Reimbursement in Europe vs....

Medical Device Global Market Access ·

2025/09/15

This episode breaks down the critical differences in securing reimbursement for In-Vitro Diagnostics (IVDs) between the European Union's national HTA bodies and the payer-driven system in the United States. We explore the specific requirements of key European agencies like Germany's G-BA and France's HAS and contrast them with the evidence demanded by CMS and private insurers in the U.S. Key Questions: • Is there a single reimbursement pathway for an IVD in the European Union? • Which national

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03:19

Unlocking U.S. Medicare Coverage for Your IVD Test

Medical Device Global Market Access ·

2025/09/14

This episode breaks down the complex process of how the U.S. Centers for Medicare & Medicaid Services (CMS) decides whether to cover a new in-vitro diagnostic (IVD) test. We explore the critical "reasonable and necessary" standard, the difference between National and Local Coverage Determinations, and the vital role of clinical utility evidence in securing a positive decision. Learn about the specific frameworks CMS uses and the specialized programs in place for advanced diagnostics.Key

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03:26

IVD Pricing Power: The Post-Market Data Payers Demand

Medical Device Global Market Access ·

2025/09/13

This episode delves into the critical post-market data strategies required to secure and defend reimbursement for innovative in-vitro diagnostics (IVDs). We explore the distinct evidence that persuades U.S. insurers versus EU payers, moving beyond initial regulatory approval to focus on long-term value demonstration. Learn about the types of real-world evidence, registry studies, and economic data that are most effective for renegotiating coverage and justifying premium pricing in these key global

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260 results

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