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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

03:21

Singapore HSA: A Guide to Medical Device Risk...

Medical Device Global Market Access ·

2026/02/21

This episode provides a detailed guide to Singapore's Health Sciences Authority (HSA) medical device risk classification system. We explore the four-tier structure (Class A to Class D), explain how it aligns with international GHTF/IMDRF principles, and discuss how factors like intended use and invasiveness determine a device's class. Understanding this foundational step is crucial as it dictates the entire regulatory pathway for market access in Singapore. Key Questions: - What are the four risk

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02:55

Singapore Medical Device Registration: Navigating the...

Medical Device Global Market Access ·

2026/02/20

This episode provides a detailed overview of Singapore's medical device registration framework. We cover the role of the Health Sciences Authority (HSA), the foundational Health Products Act 2007 and Medical Devices Regulations 2010, the four-tiered risk classification system, and the various registration pathways available to manufacturers based on prior approvals in reference markets.- What is the primary legislation governing medical devices in Singapore? - How does the Health Sciences

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02:58

Navigating INVIMA: Colombian Rules for Medical Device...

Medical Device Global Market Access ·

2026/02/19

This episode provides a detailed overview of the regulatory requirements for medical device labeling, Instructions for Use (IFU), and Spanish translation for market entry into Colombia. We explore the specific rules set by the national authority, INVIMA, and explain how these elements are meticulously evaluated during the registration process to ensure patient safety and device efficacy.- What is INVIMA's primary language requirement for medical device labels in Colombia? - Which Colombian decree

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03:11

Colombia's INVIMA Medical Device Registration: A...

Medical Device Global Market Access ·

2026/02/18

This episode provides a detailed breakdown of the costs associated with registering a medical device in Colombia with the regulatory authority, INVIMA. We cover the official government application fees based on risk classification, as well as essential ongoing costs such as renewals, modification fees, and the expenses related to local representation and translation services, giving you a complete financial picture for market entry.- What are the official INVIMA government fees for medical device

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03:05

Colombia's INVIMA Registration: Is FDA or CE Mark...

Medical Device Global Market Access ·

2026/02/17

This episode explores the requirements for medical device registration in Colombia, focusing on whether prior approval from a reference country like the US or EU is mandatory. We detail the role of a Certificate of Free Sale (CFS), the different regulatory pathways defined by INVIMA based on device risk classification (Class I, IIa, IIb, III), and the specific process available for novel devices that have not yet received marketing authorization in any country.- Is a Certificate of Free Sale (CFS)

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03:10

Colombia INVIMA Medical Device Registration:...

Medical Device Global Market Access ·

2026/02/16

This episode provides a detailed guide on the essential documents required for medical device registration in Colombia through the regulatory body, INVIMA. We cover the critical importance of the Certificate of Free Sale (CFS), the specific requirements for legalization and apostilles, the necessity of a local legal representative, and the comprehensive components of the technical file, including the mandatory Spanish language requirement. - What is the role of INVIMA in Colombia's medical device

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03:07

Colombia's INVIMA Approval Timelines: Standard vs....

Medical Device Global Market Access ·

2026/02/15

This episode explores the medical device registration process in Colombia, focusing on the timelines set by the regulatory authority, INVIMA. We break down the key differences between the standard (controlled) review pathway for high-risk devices and the expedited (automatic) process for lower-risk devices, including eligibility requirements and realistic time-to-market estimates for each. This is essential information for any MedTech company considering market entry into Colombia.- What is INVIMA

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03:18

Colombia's INVIMA Regulations: Legal Representative...

Medical Device Global Market Access ·

2026/02/14

This episode details the mandatory requirement for a local authorized representative for medical device registration in Colombia. We explore the legal responsibilities this representative assumes as stipulated by the regulatory authority, INVIMA, under Decree 4725 of 2005. The discussion covers their central role in registration, post-market surveillance (technovigilance), and communication with authorities, while also highlighting the strategic importance of choosing an independent representative

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02:45

Colombia's Medical Device Classification: Navigating...

Medical Device Global Market Access ·

2026/02/13

This episode provides a detailed overview of Colombia's medical device risk classification system as regulated by INVIMA under Decree 4725 of 2005. We explain the four-tiered risk classes (Class I, IIa, IIb, and III), the criteria used for classification such as invasiveness and duration of use, and how a device's class determines its regulatory pathway for market approval in this key Latin American market.- What is the primary regulation governing medical device classification in Colombia? - How

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02:42

Colombia's INVIMA: Medical Device Registration...

Medical Device Global Market Access ·

2026/02/12

This episode provides a comprehensive guide for foreign medical device manufacturers on registering their products in Colombia. We cover the role of the regulatory authority, INVIMA, the risk-based device classification system, and the essential documentation required for a successful submission, including the Certificate of Free Sale (CFS) and ISO 13485 certification. The host details the distinct timelines for low-risk and high-risk devices, explaining the expedited pathway for Class I and IIa

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03:27

EU MDR & IVDR Readiness: Mastering Economic Operator...

Medical Device Global Market Access ·

2026/02/11

This episode breaks down the critical responsibilities of Economic Operators—Manufacturer, Authorised Representative, Importer, and Distributor—and the Person Responsible for Regulatory Compliance (PRRC) under the EU's MDR and IVDR. We explore the common operational pitfalls, such as role confusion, misaligned contracts, and PRRC coverage gaps, that frequently lead to audit findings and can jeopardize your market access in the European Union.Key Questions: - What are the four legally distinct

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03:28

MedTech's Sustainability Dilemma: Reprocessing, Risk,...

Medical Device Global Market Access ·

2026/02/10

This episode explores the growing tension between single-use medical devices and the push for sustainability. We delve into the complex world of reprocessing, examining the regulatory hurdles, validation requirements, and critical liability shifts under frameworks like the US FDA and the EU's Medical Device Regulation (MDR). We discuss how this trend impacts manufacturers, from Instructions for Use (IFU) to risk management, and what the future holds as the circular economy reshapes MedTech business

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03:08

Unlocking European Markets: Companion Diagnostics...

Medical Device Global Market Access ·

2026/02/09

This episode details the significant regulatory complexities for Companion Diagnostics (CDx) under the European Union's In Vitro Diagnostic Regulation (IVDR). We explore why these devices are now in a higher risk class, the impact of mandatory consultations with medicinal authorities like the EMA, and the critical need for seamless coordination between IVD manufacturers and their pharmaceutical partners to ensure timely market access.Key Questions: - What makes Companion Diagnostics (CDx) a unique

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03:05

EU IVDR Clarity: Navigating IVD Performance Studies...

Medical Device Global Market Access ·

2026/02/08

This episode demystifies the requirements for In-Vitro Diagnostic (IVD) performance studies under the EU's IVDR. We explore the crucial guidance document, MDCG 2025-5, published in June 2024, to clarify common points of confusion for manufacturers. We cover the key differences between study notifications and applications, what constitutes a 'substantial modification,' the rules for using leftover samples, and how to manage combined studies, helping you avoid costly delays and regulatory rework.Key

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03:19

Navigating EU IVDR: A Deep Dive into Performance...

Medical Device Global Market Access ·

2026/02/07

This episode provides a detailed breakdown of the three pillars of performance evaluation required under the EU's In Vitro Diagnostic Regulation (IVDR): scientific validity, analytical performance, and clinical performance. We focus specifically on the heightened requirements and common pitfalls for manufacturers of high-risk Class C and D devices, explaining why underestimating the clinical evidence burden is a primary cause of delays in obtaining CE marking. - What are the three essential pillars

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03:01

EU Medical Device Cybersecurity: Navigating MDCG...

Medical Device Global Market Access ·

2026/02/06

This episode delves into the critical requirements for medical device cybersecurity in the European Union. We explore the concept of "state of the art" as defined by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), focusing on the key guidance document, MDCG 2019-16 Rev. 1. Learn how this guidance impacts your design controls, risk management, post-market surveillance, and change management processes to avoid common and costly audit nonconformities.- What does

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03:10

EU AI Act & MDR/IVDR: Decoding the New Dual...

Medical Device Global Market Access ·

2026/02/05

This episode explores the critical intersection of the new European Union AI Act and the existing Medical Device and In-Vitro Diagnostic Regulations (MDR/IVDR). We unpack the challenges of dual compliance for manufacturers of AI-enabled medical devices and explain how the recent joint guidance from the Medical Device Coordination Group and the Artificial Intelligence Board (MDCG 2025-6 / AIB 2025-1) provides a much-needed roadmap for integrating these two complex regulatory frameworks.Key

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03:11

EU SaMD Regulations: Mastering App Store Compliance...

Medical Device Global Market Access ·

2026/02/04

This episode explores the critical new regulatory focus from Europe's Medical Device Coordination Group (MDCG) on Software as a Medical Device (SaMD) distributed via online platforms. We discuss how the concept of 'making available on the market' now directly applies to app stores, forcing manufacturers to integrate platform listings, version control, and geographic restrictions into their core compliance and Quality Management Systems to avoid significant penalties.Key Questions: - What does

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03:28

EU Legacy Devices: Navigating the 'Significant...

Medical Device Global Market Access ·

2026/02/03

This episode delves into the critical definition of a "significant change" for legacy medical devices and IVDs under the EU MDR and IVDR. We explore the official MDCG guidance, outlining what types of modifications can end a device's transitional grace period, forcing an early and costly move to full certification. Learn about the high-stakes impact on market access and the importance of a robust change control process.- What is a "legacy device" and what are the new transition timelines? - How

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03:21

Beyond the Barcode: Mastering MedTech UDI for EUDAMED...

Medical Device Global Market Access ·

2026/02/02

This episode delves into the complex realities of Unique Device Identification (UDI) strategy for medical devices. The host explores common blockers that go beyond simple barcode generation, including the nuanced rules for UDI assignment across different packaging configurations, the challenges of carrier placement, and the critical importance of database submission readiness for platforms like EUDAMED. We uncover why mistakes in UDI can cascade into significant traceability and recall issues, and

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309 results

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