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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

04:37

SFDA AI Medical Software: Market Access in Saudi...

Medical Device Global Market Access ·

2026/09/15

The Saudi Food and Drug Authority (SFDA) has approved its first two locally developed AI-enabled Software as a Medical Device (SaMD) products, 'Dental IQ' and 'SAARIA,' on September 10, 2026. This episode explores the significance of this regulatory milestone, what it reveals about the SFDA's Innovative Medical Devices Pathway, and the key technical and clinical requirements for manufacturers of AI medical software seeking market access in Saudi Arabia.Key Questions: - What major regulatory

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05:22

Australia TGA CDSS Exemption 2026: What SaMD...

Medical Device Global Market Access ·

2026/09/14

Australia's Therapeutic Goods Administration (TGA) has amended the exemption criteria for Clinical Decision Support Software (CDSS), effective November 1, 2026. This episode breaks down the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026, explaining the clarified distinction between exempt software that 'informs' clinical decisions and regulated Software as a Medical Device (SaMD) that 'guides' or 'drives' them. We discuss the direct impact on SaMD manufacturers and

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05:06

India CBIC Medical Device Import Checklist: New...

Medical Device Global Market Access ·

2026/09/13

India's Central Board of Indirect Taxes and Customs (CBIC) has introduced a new standardized checklist for the import clearance of medical devices, effective from early September 2026. This episode details the new requirements, the mandatory use of the e-SANCHIT portal for document submission, and how this initiative, in coordination with the CDSCO, aims to streamline customs, enhance transparency, and reduce delays for medical device importers.Key Questions: - What is the new standardized

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05:01

China NMPA's Dynamic Adjustment of Medical Device...

Medical Device Global Market Access ·

2026/09/12

This episode details China NMPA's new 'dynamic adjustment' mechanism for medical device classification, introduced in Announcements No. 52 and 53 on September 8, 2026. We explain how this shift from a static catalog to a fluid, data-driven system impacts manufacturers. The host covers the new concept of 'transitional periods' for reclassified devices and provides practical actions for regulatory and quality teams to adapt their strategies for long-term compliance and market access in China. Key

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04:45

SFDA Medical Device Advertising: Responding to...

Medical Device Global Market Access ·

2026/09/11

On September 6, 2026, the Saudi Food and Drug Authority (SFDA) announced legal action against a medical device company for misleading advertising. This episode breaks down the SFDA's announcement, the core principles of Saudi Arabia's medical device advertising regulations, and the potential consequences of non-compliance. We provide practical, actionable steps for manufacturers to audit their promotional materials and implement robust internal controls to ensure all marketing claims are

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04:04

Australia TGA Device Classification Rules: Saline...

Medical Device Global Market Access ·

2026/09/10

Australia's Therapeutic Goods Administration (TGA) has introduced a new classification rule, Clause 2.2, that reclassifies non-invasive devices containing only saline for flushing or maintaining another device, such as pre-filled saline syringes, to Class IIa. This episode details the scope of the new rule, the critical compliance date of September 7, 2026, for new applications, and the five-year transition period for devices already on the Australian Register of Therapeutic Goods (ARTG). We provide

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04:53

China NMPA Approves LEQEMBI Autoinjector: A Signal...

Medical Device Global Market Access ·

2026/09/09

This episode examines the September 3, 2026, approval of the LEQEMBI (lecanemab) subcutaneous autoinjector by China's NMPA. We explore how this shift from bi-weekly IV infusions to once-weekly at-home administration impacts Alzheimer's treatment and what the NMPA's use of the Priority Review pathway signals to manufacturers of innovative drug-device combination products seeking access to the Chinese market.Key Questions: - What are the key differences between the new subcutaneous LEQEMBI

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05:10

Brazil ANVISA High-Risk Device Registration: Public...

Medical Device Global Market Access ·

2026/09/08

This episode details Brazil ANVISA's Public Consultation No. 1,248, published on August 26, 2026, which proposes a new regulatory framework for the registration of Class III and IV high-risk medical devices. We discuss the key changes to technical documentation requirements, the move to align with international standards, the impact on manufacturers and their Brazilian Registration Holders (BRH), and the critical 45-day feedback period closing in October 2026. Learn the practical steps your

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05:50

Brazil ANVISA's New Notification Guidance: What Class...

Medical Device Global Market Access ·

2026/09/07

Brazil's ANVISA has published two new guidance manuals detailing the 'notification' pathway for Class I and II medical devices and IVDs. This episode explains how these manuals, released on August 25, 2023, clarify the submission processes under RDC 751/2022 and RDC 830/2023, what practical information they contain for manufacturers, and the concrete steps regulatory teams should take to streamline market access for lower-risk products in Brazil.Key Questions: - What are the new ANVISA guidance

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05:06

Singapore HSA's New Registration Pathway for Special...

Medical Device Global Market Access ·

2026/09/06

Singapore's Health Sciences Authority (HSA) launched a Registration Support Initiative on August 28, 2026, to help transition clinically important medical devices from the Special Access Route (SAR) to full market registration. This episode details the purpose of this new pathway, the eligibility criteria for devices serving small patient populations, the significant evaluation-fee waiver, and the inaugural application deadline of December 31, 2026. We provide practical steps for manufacturers to

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04:27

UK MHRA Health Bill Amendments 2026: New Powers for...

Medical Device Global Market Access ·

2026/09/05

The UK government has proposed three amendments to the Health Bill, introduced on September 1, 2026, that grant significant new powers to the MHRA. This episode breaks down what these changes—enhanced information sharing, agile regulatory updates via secondary legislation, and the foundation for a future UK-specific device licensing system—mean for medical device manufacturers. We discuss the strategic implications for companies relying on CE marking for UK market access and outline practical steps

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05:09

UK MHRA's New Licensing Powers: What the 2026 Health...

Medical Device Global Market Access ·

2026/09/04

This episode explores the significant amendments to the UK Health Bill introduced on September 1, 2026, which grant the MHRA new powers to establish a future medical device licensing regime. We analyze the potential shift from the current system of third-party UK Approved Bodies to a direct licensing model where the MHRA would approve devices. We discuss the long-term implications for manufacturers' market access strategies in Great Britain, who is affected, and the practical steps regulatory teams

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05:15

UK MHRA Non-Compliant Devices: DSI/2026/007 and...

Medical Device Global Market Access ·

2026/09/03

The UK's MHRA has issued Device Safety Information notice DSI/2026/007, warning of non-compliant medical devices on the UK market lacking valid UKCA or CE marking. This episode breaks down the immediate actions required for healthcare providers and suppliers, such as quarantining suspect products and reporting to the MHRA. We also explore the critical implications for manufacturers, focusing on the need for enhanced post-market surveillance and rigorous supply chain oversight to prevent patient risk

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04:03

Australia TGA Consultation on Medical Device...

Medical Device Global Market Access ·

2026/09/02

Australia's Therapeutic Goods Administration (TGA) has launched a consultation on proposals to increase the public sharing of medical device information. This episode breaks down the TGA's initiative, which was announced on August 13, 2026, and explores its potential impact on manufacturers and sponsors. We discuss the types of information that may become public, the implications for post-market surveillance and data management, and the crucial feedback deadline of October 2, 2026. Learn the

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05:41

Health Canada Special Access Program: New Application...

Medical Device Global Market Access ·

2026/09/01

Health Canada has modernized the application process for its Medical Devices Special Access Program (SAP) as of August 24, 2026. This episode details the two key changes: the introduction of a new accessible PDF application form and a new secure online submission method. We explore Health Canada's goals to reduce errors, improve data security, and accelerate review times for unauthorized devices needed for patients with serious conditions, outlining the practical steps for healthcare professionals

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04:55

UK MHRA ResMed Astral Alert: Ventilator Safety...

Medical Device Global Market Access ·

2026/08/31

The UK's MHRA issued National Patient Safety Alert NatPSA/2026/004/MHRA on August 17, 2026, for ResMed Astral 100 and 150 ventilators manufactured before October 2024. A faulty internal supercapacitor can leak, causing the device to shut down unexpectedly and risking serious injury or death. This episode details the specific device fault, the risks to patients, and the mandatory actions required by the MHRA for healthcare providers and manufacturers. We focus on the critical importance of

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05:00

China NMPA Medical Device Approval: Analyzing the...

Medical Device Global Market Access ·

2026/08/30

China's NMPA announced the approval of 122 medical devices on August 12, 2026, including many from leading international manufacturers such as Medtronic, Roche, and Siemens. This episode breaks down this significant regulatory event, analyzing the types of devices approved—from cardiovascular and IVDs to imaging and surgical tools. We explore what this large batch of approvals reveals about the NMPA's current review priorities, the opportunities available for foreign manufacturers, and the practical

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05:15

Singapore HSA's New Medical Device Cybersecurity...

Medical Device Global Market Access ·

2026/08/29

Singapore's Health Sciences Authority (HSA) has released its finalized 'Best Practices Guide for Medical Device Cybersecurity' (GL-10-R1), effective August 17, 2026. This episode explores the guide's three core principles—secure-by-design, shared responsibility, and transparency—and outlines their impact on manufacturers and healthcare providers. We discuss how these recommendations affect the total product lifecycle, from pre-market design to post-market surveillance, and provide actionable steps

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05:02

COFEPRIS Medical Device Sanitary Registry Viewer:...

Medical Device Global Market Access ·

2026/08/28

Mexico's health authority, COFEPRIS, has launched the Medical Device Sanitary Registry Viewer, a public digital tool for verifying device registrations. This episode explores how this platform, launched on August 20, 2026, enhances market transparency and simplifies compliance. We discuss how the tool works, its impact on manufacturers, distributors, and healthcare providers, and outline practical steps for regulatory teams to adapt to this new environment.Key Questions: - What is the new COFEPRIS

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04:21

India CDSCO Amends Sterilization Rules: What Removing...

Medical Device Global Market Access ·

2026/08/27

India's CDSCO has amended the Medical Devices Rules, 2017, effective August 24, 2024, removing the 'loan licence' requirement for manufacturers who outsource device sterilization. This episode explains the amendment, details the new mandatory labeling requirements for sterilized products, and outlines the practical steps that regulatory and quality teams must take during the six-month transition period to ensure compliance.Key Questions: - What was the 'loan licence' requirement for medical device

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