Shows / Medical Device Global Market Access
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…
Episodes
- Medical Device Global Market Access
Partnering for Success: Navigating Mexico's Medical Imaging Sector
This episode explores the strategic advantages of partnering with specialized local distributors to enter Mexico's medical imaging and radiology market. We…
- Medical Device Global Market Access
Mexico's Radiology Market: A Distributor's Role with Agfa, Philips, and IMADINE
This episode explores the intricacies of Mexico's medical imaging and radiology market. We focus on the crucial role of local distributors by examining…
- Medical Device Global Market Access
Unlocking Mexico: A Strategic Guide to Orthopedic & Trauma Device Distribution
This episode explores the strategic nuances of entering Mexico's orthopedic and trauma medical device market. We analyze the successful distribution model of…
- Medical Device Global Market Access
COFEPRIS Registration & Market Strategy for Orthopedic Devices in Mexico
This episode explores the strategic importance of local partnerships for medical device market access in Mexico, using orthopedic and trauma device distributor…
- Medical Device Global Market Access
Mexico's Orthopedic Implants Market: Navigating COFEPRIS Regulations & Trauma Sector Growth
This episode explores Mexico's dynamic orthopedic and trauma device market, detailing its significant growth drivers, including medical tourism and an…
- Medical Device Global Market Access
Mexico Market Access: The Role of Specialized Distributors in Interventional Cardiology & Radiology
This episode examines the strategic importance of specialized local distributors for medical device market access, using DPM Distribuidores de Productos…
- Medical Device Global Market Access
Accessing Mexico’s MedTech Scene: A Case Study in Interventional Cardiology and Radiology
This episode explores Mexico's advanced medical device market through a case study of Endomédica, a leading distributor in interventional cardiology and…
- Medical Device Global Market Access
Mexico's COFEPRIS Approval: Fast-Tracking Cardiology & Radiology Devices
This episode explores the lucrative Mexican market for interventional cardiology and radiology devices, detailing the COFEPRIS registration process. We cover…
- Medical Device Global Market Access
Brazil's Dental Market: Unlocking Access with Key Distributors like Dental Speed
This episode explores Brazil's lucrative dental device market, highlighting the critical role of established local distributors for successful market entry. We…
- Medical Device Global Market Access
Brazil's Dental Market: Unlocking Access with Dental Cremer and Henry Schein
This episode provides a deep dive into Dental Cremer, a Henry Schein company, and its dominant role in the Brazilian dental device market. We explore how its…
- Medical Device Global Market Access
Brazil's Diagnostic Imaging Boom: Navigating Market Entry After ANVISA's 2024 Regulatory Shift
This episode explores Brazil's rapidly growing diagnostic imaging market, a key area for global MedTech companies like Philips Healthcare. We analyze the…
- Medical Device Global Market Access
Siemens Healthineers: AI, CT, and Cardiology Imaging in Brazil
This episode explores Siemens Healthineers' significant role in Brazil's diagnostic imaging market. We cover their extensive portfolio of CT, MR, angiography…
- Medical Device Global Market Access
GE HealthCare's Brazil Strategy: Localizing Diagnostic Imaging Manufacturing
This episode delves into GE HealthCare's strategic investment in Brazil, examining the establishment of its first diagnostic imaging manufacturing facility in…
- Medical Device Global Market Access
DePuy Synthes in Brazil: Navigating ANVISA's RDC 751/2022 for Orthopedic Devices
This episode examines the Brazilian market for orthopedic medical devices, using DePuy Synthes (a J&J MedTech company) as a case study. We break down the…
- Medical Device Global Market Access
Zimmer Biomet in Brazil: A Blueprint for Orthopedic Device Market Access & ANVISA Compliance
This episode explores the strategic pathway for medical device market entry into Brazil, the largest MedTech market in Latin America. We analyze the case of…
- Medical Device Global Market Access
Cracking the Brazilian Market: How Stryker Dominates Orthopedic Device Distribution
This episode examines Stryker do Brasil's successful strategy for dominating the Brazilian orthopedics market. We explore their extensive national distributor…
- Medical Device Global Market Access
Unlocking the Brazilian MedTech Market: ANVISA's Reliance Route & High-Risk Cardiology Devices
This episode explores the lucrative but complex medical device market in Brazil, the largest in Latin America. Using Abbott's Cardiac Rhythm Management (CRM)…
- Medical Device Global Market Access
Brazil Market Access: Boston Scientific's Cardiology Playbook
This episode explores the strategic approach of Boston Scientific in the Brazilian medical device market, focusing on its cardiology and electrophysiology…
- Medical Device Global Market Access
Brazil MedTech Market: A Medtronic Cardiology Case Study on Long-Term Success
This episode analyzes how Medtronic has achieved long-term success in Brazil's complex cardiology device market. We explore their strategy of combining product…
- Medical Device Global Market Access
Global MedTech Expansion: Key Strategies for Market Access in the US, EU, and Asia
This episode breaks down the core components of a successful global market access strategy for MedTech and IVD companies. We explore the importance of building…
- Medical Device Global Market Access
McKesson's 2025 Spin-Off: A New Era for US Medical Device Distribution
This episode delves into McKesson's major announcement from May 2025 to spin off its Medical-Surgical Solutions (MMS) division into a new, independent company…
- Medical Device Global Market Access
Cardinal Health's GMPD: A Deep Dive into US Medical Distribution Strategy for 2025
This episode provides a detailed analysis of Cardinal Health's Global Medical Products & Distribution (GMPD) segment, a dominant force in the U.S. medical…
- Medical Device Global Market Access
The Medline Advantage: U.S. Market Dominance and a Landmark 2025 IPO
This episode explores Medline Industries, the top medical-surgical distributor in the United States. We uncover the immense scale of its operations, its unique…
- Medical Device Global Market Access
The US Hearing Aid Boom: Decoding the FDA's OTC Rule and 2025 Market Strategy
This episode explores the transformation of the U.S. hearing aid market following the FDA's landmark 2022 rule that established an over-the-counter (OTC)…
- Medical Device Global Market Access
CPAP & APAP Technology: Navigating the Booming US Sleep Apnea Market
This episode explores the robust and growing U.S. market for Continuous Positive Airway Pressure (CPAP) and Automatic Positive Airway Pressure (APAP) devices…
- Medical Device Global Market Access
Pacemakers and ICDs in 2024-2025: Key Global Market and Technology Shifts
This episode explores the dynamic landscape of Cardiac Implantable Electronic Devices (CIEDs), including pacemakers, ICDs, and CRT devices. We discuss why…
- Medical Device Global Market Access
U.S. Joint Arthroplasty Trends: Robotics, Demographics, and the 2025 Implant Market
This episode delves into the U.S. market for hip and knee replacement implants, analyzing data from the American Joint Replacement Registry’s 2024 report. We…
- Medical Device Global Market Access
US Market Access: How CMS Reimbursement Fueled the CGM and Insulin Pump Boom
This episode explores the rapid adoption of Continuous Glucose Monitors (CGMs) and insulin pumps in the United States, detailing how changes in reimbursement…
- Medical Device Global Market Access
AI-Powered MedTech Regulation: Slashing Global Market Access Time by 75%
This episode explores how MedTech companies are leveraging advanced AI agents to overcome traditional hurdles in global medical device regulation. We discuss…
- Medical Device Global Market Access
AI in MedTech Regulation: 70% Faster FDA Submissions & Japan Compliance Case Studies
This episode explores real-world case studies of MedTech companies using advanced AI agents to accelerate FDA submissions, expand into multiple European…
- Medical Device Global Market Access
Unlocking Global Markets: End-to-End Regulatory Services for MedTech and IVD Devices
This episode details the full range of medical devices and regulatory services supported for global market access. We explain our expertise with both MedTech…
- Medical Device Global Market Access
Scaling MedTech: Tailored Regulatory Strategies for Startups, Scaleups, and Global Enterprises
This episode explores how regulatory strategies for MedTech and IVD devices must adapt to a company's growth stage. We discuss the unique challenges and…
- Medical Device Global Market Access
Beyond Traditional Consulting: The Future of IVD and MedTech Market Access
This episode explores the evolution of regulatory consulting for MedTech and IVD devices. We contrast the traditional, fragmented consulting model with Pure…
- Medical Device Global Market Access
Unlocking Global MedTech Markets: A Unified Strategy for Registration in the US, EU, and Asia
This episode explores how MedTech and IVD companies can overcome the complexities of international expansion. We discuss a unified, technology-driven approach…
- Medical Device Global Market Access
MedTech Market Entry: The True Cost of Free vs. Paid Regulatory Resources
This episode breaks down the crucial differences between free and paid resources in the complex world of medical device market access. We explore what you can…
- Medical Device Global Market Access
Beyond the SaaS Hype: Real AI-Powered Global Market Access for MedTech
This episode explores the critical distinction between standalone AI SaaS tools and a fully integrated, service-based approach for MedTech global market…
- Medical Device Global Market Access
MedTech Expansion Strategy: Unlocking Underserved Global Markets in LATAM and APAC
This episode explores the strategies and regulatory hurdles involved in bringing medical devices to underserved and emerging global markets. We discuss how to…
- Medical Device Global Market Access
AI in MedTech Regulatory Affairs: Scaling to 30+ Global Markets
This episode explores how Artificial Intelligence is revolutionizing the medical device registration process, breaking down financial barriers and enabling…
- Medical Device Global Market Access
Free AI Agents: The Future of Medical Device Registration in the US, EU, and Beyond
This episode explores the transformative impact of free AI-powered tools on the medical device industry. We discuss how making regulatory intelligence and…
- Medical Device Global Market Access
Colombia Medical Device Registration: Unpacking Decree 4725 of 2005
This episode provides a detailed overview of Colombia's foundational medical device regulation, Decree 4725 of 2005. We explore the critical role of INVIMA…
- Medical Device Global Market Access
Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success
This episode provides a detailed overview of Mexico's Technovigilance requirements for medical devices under COFEPRIS regulation NOM-240-SSA1-2012. We explore…
- Medical Device Global Market Access
Mexico's New Medical Device Labeling Standard: A Deep Dive into NOM-137-SSA1-2024
This episode provides a critical update on Mexico's new mandatory standard for medical device labeling, NOM-137-SSA1-2024. The host breaks down the key changes…
- Medical Device Global Market Access
Navigating NOM-241-SSA1-2021: Medical Device GMP Compliance in Mexico
This episode provides a detailed overview of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. The host breaks down the key…
- Medical Device Global Market Access
Navigating COFEPRIS: A Deep Dive into Mexico's 'Reglamento de Insumos para la Salud' for Medical Devices
This episode provides a detailed overview of Mexico's medical device regulations, focusing on the Reglamento de Insumos para la Salud. We explore the role of…
- Medical Device Global Market Access
Mexico's COFEPRIS Framework: A Deep Dive into the Ley General de Salud for Medical Devices
This episode provides a comprehensive overview of Mexico's foundational health regulation, the Ley General de Salud, and its impact on medical device market…
- Medical Device Global Market Access
Brazil GMP Certification: A Deep Dive into RDC 687/2022 for Class III/IV Devices
This episode provides a detailed analysis of Brazil's RDC 687/2022, a critical regulation from ANVISA governing Good Manufacturing Practices (GMP)…
- Medical Device Global Market Access
Navigating Brazil's ANVISA Technovigilance: A Deep Dive into RDC 67/2009 Reporting Timelines
This episode provides a detailed overview of Brazil's key technovigilance regulations for medical devices, RDC 67/2009 and RDC 551/2021. We explore the…
- Medical Device Global Market Access
Brazil's BGMP Overhaul: Navigating ANVISA RDC 665/2022 and MDSAP Compliance
This episode explores Brazil's key regulation for medical device and IVD manufacturers, ANVISA RDC 665/2022. We break down the Brazilian Good Manufacturing…
- Medical Device Global Market Access
Brazil's IVD Shake-up: ANVISA RDC 830/2023 and New Risk Classifications
This episode provides a detailed analysis of Brazil's new IVD regulation, ANVISA RDC 830/2023, which was implemented in June 2024. We explore the critical…
- Medical Device Global Market Access
ANVISA RDC 751/2022: A Manufacturer's Guide to Brazilian Device Registration
This episode provides a detailed overview of Brazil's pivotal medical device regulation, ANVISA RDC 751/2022, which became effective in March 2023. We explore…
- Medical Device Global Market Access
Singapore MedTech: How to Break Free from Distributor Lock-In
This episode delves into the critical process for medical device manufacturers to regain control of their Singapore market access by transitioning from a…
- Medical Device Global Market Access
Unlocking Your MedTech in Vietnam: The Registration Holder Dilemma
This episode delves into the critical process of changing a medical device registration holder in Vietnam. We clarify a common misconception: a direct license…
- Medical Device Global Market Access
Japan's D-MAH System: Regaining Control of Your Medical Device
This episode explores the critical strategic choice between appointing a distributor versus an independent Designated Marketing Authorization Holder (D-MAH)…
- Medical Device Global Market Access
Australia TGA Sponsor: How to Take Control of Your Medical Device Registration
This episode delves into the strategic process of changing a TGA Sponsor for medical devices in Australia. We explore the critical differences between using a…
- Medical Device Global Market Access
Unlocking India: The Strategic Advantage of an Independent Authorized Agent
This episode explores the critical process of switching your Indian Authorized Agent (IAA) with the CDSCO, moving from a commercially-tied distributor to an…
- Medical Device Global Market Access
Regain Control: Transferring Your ANMAT Registration in Argentina
This episode delves into the critical process of transferring ANMAT medical device registration in Argentina from a distributor to an independent holder. We…
- Medical Device Global Market Access
Unlock Chile: Why Your Distributor Shouldn't Own Your Medical Device Registration
This episode explores a crucial, often overlooked aspect of entering the Chilean medical device market: the selection of an in-country registration holder. We…
- Medical Device Global Market Access
Regain Control: Switching Your Medical Device Registration Holder in Peru
This episode explores the critical risks of allowing a distributor to hold your medical device registration in Peru and outlines the strategic advantages of…
- Medical Device Global Market Access
Mexico MedTech: Untangling Your COFEPRIS Registration Holder
This episode explores the critical process of transferring a medical device registration holder in Mexico. We uncover the risks of appointing a distributor as…
- Medical Device Global Market Access
Regain Control: Switching Your INVIMA Holder in Colombia
This episode explores the critical decision of who holds your INVIMA medical device registration in Colombia. We delve into the significant business risks of…