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
Health Canada MDEL Modernization Phase 2: 2026 Changes for Importers and Distributors
Health Canada has finalized Phase 2 of its Medical Device Establishment Licence (MDEL) modernization, with new rules taking effect on December 14, 2026. This…
- Medical Device Global Market Access
Australia TGA Classification Rule 5.5: Reclassification Changes for Medical Devices
Australia's TGA has amended medical device classification rule 5.5, effective July 1, 2024. The change removes materials of microbial and recombinant origin…
- Medical Device Global Market Access
Switzerland's Swissdamed: Mandatory Device and IVD Registration by July 2026
Switzerland's swissdamed database becomes mandatory on July 1, 2026, for all medical devices and IVDs. This episode details the key deadlines, including the…
- Medical Device Global Market Access
UK MHRA International Reliance: Navigating the Draft 2026 Medical Device Regulations
This episode details the UK MHRA's draft Medical Devices (Amendment) Regulations 2026, focusing on the proposed International Reliance pathway. We explore how…
- Medical Device Global Market Access
Brazil ANVISA Regulatory Reliance: June 2024 Update to IN 290/2024 Streamlines Class III/IV Device Review
Brazil's ANVISA has updated its review process for the regulatory reliance pathway under IN 290/2024. As of mid-June 2024, instead of rejecting submissions…
- Medical Device Global Market Access
China NMPA Post-Market Vigilance 2026: New Rules for Foreign Manufacturers
This episode provides a detailed analysis of China's NMPA new post-market vigilance framework, released on June 12, 2026. We discuss the mandatory, risk-based…
- Medical Device Global Market Access
Saudi SFDA's 2026 AI Medical App Approval: A Global First for Vital Signs Monitoring
On June 22, 2026, the Saudi Food and Drug Authority (SFDA) issued a landmark marketing authorization for an AI-powered mobile application that measures vital…
- Medical Device Global Market Access
UK MHRA MDSAP Membership: Streamlining Audits for UK, US, Canada, and More
The UK's MHRA announced on June 22, 2026, its intention to become a full member of the Medical Device Single Audit Program (MDSAP). This episode explores the…
- Medical Device Global Market Access
Singapore HSA COVID-19 IVD Reclassification: Class C Requirements from 2026
Singapore's Health Sciences Authority (HSA) is reclassifying all COVID-19 in-vitro diagnostic (IVD) tests from the highest-risk Class D to Class C, effective…
- Medical Device Global Market Access
India CDSCO Proposes New Medical Device Import Rules for Hospitals (2026)
India's drug regulator, the CDSCO, has proposed a new framework to allow hospitals to directly import a list of 80 high-end medical devices, such as MRI and CT…
- Medical Device Global Market Access
Health Canada's 2026 Hyperbaric Chamber Warning: Compliance for Unlicensed Devices
Health Canada issued a public advisory on June 16, 2026, warning that unauthorized soft-shelled hyperbaric chambers are illegal to sell, import, or advertise…
- Medical Device Global Market Access
Health Canada MDEL Regulations 2026: What Importers and Foreign Manufacturers Need to Know
Health Canada has finalized amended regulations for its Medical Device Establishment Licence (MDEL) framework, which come into force on December 14, 2026. This…
- Medical Device Global Market Access
FDA AI Software Classification 2026: Class II and PCCP Rules for Imaging Devices
On June 17, 2026, the US FDA finalized a new Class II classification for radiological machine learning-based quantitative imaging software. This episode breaks…
- Medical Device Global Market Access
Brazil ANVISA SaMD Regulation Update: Preparing for Changes to RDC 657/2022
Brazil's health agency, ANVISA, has announced its 2026-2027 regulatory agenda, which includes a significant revision to the rules for Software as a Medical…
- Medical Device Global Market Access
Singapore HSA's 2026 Medical Device Grouping Guidance: Key Changes in GN-12-1-R3
Singapore's Health Sciences Authority (HSA) released its updated guidance on medical device grouping, GN-12-1-R3, on June 2, 2026. This episode provides a…
- Medical Device Global Market Access
Australia TGA UDI Deadline: Class III & IIb Device Compliance by July 1, 2026
Australia's Therapeutic Goods Administration (TGA) is enforcing its first major Unique Device Identification (UDI) deadline on July 1, 2026. This episode…
- Medical Device Global Market Access
Japan PMDA SaMD Guidance: Key Changes from the June 2026 Update
On June 5, 2026, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) updated its core guidance for Software as a Medical Device (SaMD). This episode…
- Medical Device Global Market Access
FDA AI Medical Device Guidance 2026: New Rules for Transparency and Lifecycle Management
This episode breaks down the US FDA's new draft guidance on AI-enabled medical device software, released on June 6, 2026. We explore the FDA's stricter…
- Medical Device Global Market Access
FDA Payor Communications Guidance 2026: What Medical Device Manufacturers Need to Know
The US FDA's June 3, 2026 draft guidance on manufacturer communications with payors marks a significant policy shift for the medical device industry. This…
- Medical Device Global Market Access
FDA 510(k) Exemption for Unclassified Devices: New June 2026 Guidance
The US FDA has released a new final guidance, effective June 4, 2026, exempting certain unclassified medical devices from 510(k) premarket notification. This…
- Medical Device Global Market Access
EU AI Act & Medical Devices: Deadline Extended to 2028 for High-Risk Systems
The European Union has extended the compliance deadline for the AI Act for high-risk medical devices and IVDs already regulated by the MDR and IVDR. A…
- Medical Device Global Market Access
FDA 510(k) Exemption Guidance 2026: Five New Product Codes Exempted
The US FDA issued a final guidance on June 4, 2026, immediately exempting five unclassified medical device product codes from 510(k) premarket notification…
- Medical Device Global Market Access
China NMPA's New Dynamic Medical Device Classification: What Manufacturers Need to Know
This episode explores the China NMPA's new dynamic adjustment procedure for its Medical Device Classification Catalog, effective June 1, 2026. We discuss what…
- Medical Device Global Market Access
EU Notified Body Timelines: New MDR & IVDR Rules for Predictable CE Marking
The European Commission has adopted Implementing Regulation (EU) 2026/977, establishing harmonized and binding timelines for Notified Body conformity…
- Medical Device Global Market Access
UK MHRA Draft 2026 Medical Device Regulations: International Reliance and What's Next
The UK's MHRA has published draft medical device regulations set for 2026, introducing a new standalone framework for Great Britain. This episode breaks down…
- Medical Device Global Market Access
Mexico's New Medical Device Labeling Standard: COFEPRIS NOM-137-SSA1-2025 Compliance by 2027
In this episode, we break down Mexico's new comprehensive medical device labeling standard, NOM-137-SSA1-2025, published by the health regulator COFEPRIS. We…
- Medical Device Global Market Access
FDA's New Human Factors Guidance: Navigating Risk for 510(k) and PMA Submissions
In this episode, we explore the U.S. FDA's significant new guidance on Human Factors Engineering (HFE) for medical devices. The host breaks down the new…
- Medical Device Global Market Access
The EUDAMED Countdown: Mandatory EU Device Registration Begins May 28, 2026
This episode details the critical EUDAMED deadline of May 28, 2026, when four key modules become mandatory for medical device and IVD manufacturers in the EU…
- Medical Device Global Market Access
Winning the Heart: MedTech's Race for a Full Structural Heart Ecosystem by 2026
This episode explores the future of the structural heart market, a key growth area in MedTech. We discuss the technological advancements in imaging, catheter…
- Medical Device Global Market Access
The 2026 Neurotechnology Leap: Navigating BCI Commercialization, Reimbursement, and FDA Hurdles
This episode explores the imminent commercialization of Brain-Computer Interface (BCI) technology, moving it from a futuristic concept to a medical reality by…
- Medical Device Global Market Access
AI Scribes & Ambient Documentation: A 2026 Clinical Infrastructure Forecast
This episode explores the future of AI in healthcare, focusing on whether ambient documentation and AI-powered charting will become standard clinical…
- Medical Device Global Market Access
AI Chatbot Governance in MedTech: Balancing Safety and Speed in 2026
This episode explores the critical challenge MedTech leaders face in 2026 regarding the safe implementation of AI chatbots in healthcare. We discuss how to…
- Medical Device Global Market Access
The 2026 Diagnostics Revolution: Value Creation in Molecular Testing, Oncology, and Personalized Medicine
This episode explores the significant market shift toward molecular and genetic diagnostics projected for 2026. We analyze the key drivers behind this trend…
- Medical Device Global Market Access
Medicare's PAMA Problem: Will 2026 Reimbursement Cuts Crush US Diagnostics Innovation?
This episode examines the critical threat facing the U.S. diagnostics industry due to flawed implementation of the Protecting Access to Medicare Act (PAMA). We…
- Medical Device Global Market Access
2026 MedTech M&A Forecast: Blockbuster Deals in Diagnostics & Structural Heart or Continued Caution?
This episode forecasts the state of medical technology mergers and acquisitions for 2026. We analyze whether the industry will see a return to large…
- Medical Device Global Market Access
2026 MedTech Forecast: Tariffs, Supply-Chain Nationalism, and Manufacturing Strategy
This episode explores the significant impact that rising tariffs and supply-chain nationalism are projected to have on the medical technology industry by 2026…
- Medical Device Global Market Access
The Great EU MedTech Squeeze: Portfolio Pruning and Consolidation Under MDR/IVDR in 2026
This episode examines the immense pressures facing medical device manufacturers from Europe's Medical Device Regulation (MDR) and In-Vitro Diagnostic…
- Medical Device Global Market Access
FDA's 2026 MDUFA Impact: A Strategic Guide for Small MedTech Companies
This episode delves into the upcoming 2026 Medical Device User Fee Amendments (MDUFA VI) negotiations and their profound impact on the U.S. medtech landscape…
- Medical Device Global Market Access
The 2026 AI MedTech Challenge: Cracking the Reimbursement Code
This episode explores the prediction that by 2026, the primary obstacle for AI medical devices will shift from technical validation to securing financial…
- Medical Device Global Market Access
Diabetes Tech in 2026: The Battle Between Closed-Loop Innovation and Regulatory Reality
This episode explores the future of the diabetes technology market, examining the critical tension between rapid innovation and foundational regulatory…
- Medical Device Global Market Access
Decentralized Diagnostics: Regulatory Pathways for AI-Powered Imaging in 2026
This episode explores the transformative potential of AI-enabled imaging and ultrasound tools designed for non-experts, set to reshape diagnostics by 2026. We…
- Medical Device Global Market Access
The 2026 Surgical Robotics Shake-Up: FDA Approvals, Specialization, and New Competition
This episode explores the transformative shift in the surgical robotics market, predicting a move away from a single-player monopoly by 2026. We analyze the…
- Medical Device Global Market Access
FDA's New Cybersecurity Era: Why SBOMs and Secure Architecture are Non-Negotiable for MedTech by 2026
This episode examines how U.S. FDA regulations have repositioned cybersecurity as a core feature of medical devices. We discuss the impact of the Consolidated…
- Medical Device Global Market Access
FDA's 2026 TEMPO Pilot: The Bridge to Reimbursement for Digital Health?
This episode delves into the U.S. FDA's upcoming Total Product Life Cycle (TPLC) Advisory Program, known as TEMPO, set to launch in 2026. We explore its…
- Medical Device Global Market Access
U.S. FDA vs. Wearables: The 2026 Regulatory Showdown for Digital Health
This episode explores the evolving regulatory landscape for digital health, focusing on the U.S. FDA's projected stance in 2026. We dissect the critical line…
- Medical Device Global Market Access
FDA's 2026 AI Device Scrutiny: Lifecycle Governance and Real-World Performance
This episode explores the FDA's expected regulatory landscape for AI-enabled medical devices in 2026. We discuss the critical shift from pre-market assessment…
- Medical Device Global Market Access
Home-Use Device Recalls & Firmware Updates: Navigating the MedTech Logistical Nightmare
This episode delves into the top health technology hazard: the logistical challenges of communicating recalls and firmware updates for home-use medical…
- Medical Device Global Market Access
Securing the MedTech Supply Chain: Blockchain vs. 3D-Printed Counterfeits
The rise of sophisticated 3D-printed counterfeit medical devices presents a grave threat to patient safety and brand integrity. This episode delves into the…
- Medical Device Global Market Access
Self-Healing Logistics: Automating Medical Device Supply Chains in a Volatile World
This episode explores the rise of "self-healing" supply chains, an AI-driven solution designed to combat the logistical nightmares caused by modern…
- Medical Device Global Market Access
AI Diagnostic Bias: Navigating FDA and Global Regulations to Avoid Market Withdrawal
This episode explores the growing regulatory pressure on medical device manufacturers to mitigate algorithmic bias in AI-powered diagnostics. We discuss why…
- Medical Device Global Market Access
ASC Sales Strategy: Adapting MedTech for the 2026 Procedure Shift
This episode explores the strategic pivot required for MedTech companies as over 500 surgical procedures shift to Ambulatory Surgery Centers (ASCs) by 2026. We…
- Medical Device Global Market Access
MedTech's Subscription Shift: Surviving the Death of Hospital Capital Expenditures
This episode explores the pivotal shift in hospital procurement from traditional capital expenditures (CapEx) to subscription-based Device-as-a-Service (DaaS)…
- Medical Device Global Market Access
USA's Breakthrough Device Dilemma: Closing the Medicare Reimbursement Gap
This episode delves into the critical reimbursement gap facing innovative medical devices in the United States. We explore why FDA Breakthrough Device…
- Medical Device Global Market Access
Beyond the AI Hype: The Human Validation Bottleneck in MedTech Submissions
This episode delves into the growing use of agentic AI for drafting complex regulatory dossiers like FDA 510(k)s and EU Technical Files. We explore the paradox…
- Medical Device Global Market Access
Cybersecurity in MedTech: Surviving Digital Darkness and Meeting FDA & EU Demands
This episode explores the growing threat of 'digital darkness'—total network outages caused by cyberattacks—and its impact on the medical device industry. We…
- Medical Device Global Market Access
Beyond the Clinical Trial: Unlocking MedTech Market Access with Real-World Evidence
This episode explores the pivotal shift from traditional clinical trial data to the increasing demand for continuous Real-World Evidence (RWE) for medical…
- Medical Device Global Market Access
EU AI Act: Navigating High-Risk Classification & Dual MDR/IVDR Compliance for Medical Devices
This episode delves into the EU's new Artificial Intelligence Act and its significant impact on medical device manufacturers. We explore the "high-risk"…
- Medical Device Global Market Access
FDA's QMSR Shift: Harmonizing US Quality Systems with ISO 13485 Before 2026
This episode breaks down the FDA's final rule transitioning the Quality System Regulation (21 CFR Part 820) to the ISO 13485-aligned Quality Management System…
- Medical Device Global Market Access
EU MDR Compliance: Surviving the Notified Body Capacity Shortage in Europe
This episode delves into the critical capacity crisis among Notified Bodies under the EU's Medical Device Regulation (MDR). We explore how the stringent…
- Medical Device Global Market Access
Countdown to EUDAMED: Mastering the EU's May 2026 MedTech Deadline
This episode dives into one of the most significant challenges facing medical device manufacturers in 2026—the mandatory EUDAMED registration deadline. We…