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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

05:20

Australia TGA Classification Rule 5.5:...

Medical Device Global Market Access ·

2026/06/30

Australia's TGA has amended medical device classification rule 5.5, effective July 1, 2024. The change removes materials of microbial and recombinant origin from the scope of the rule, which previously mandated a Class III classification. This will lead to the down-classification of certain devices, such as some dermal fillers or surgical meshes, likely to Class IIb. Sponsors of existing devices on the ARTG must submit a reclassification application before the critical deadline of July 1, 2026, to

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04:45

Switzerland's Swissdamed: Mandatory Device and IVD...

Medical Device Global Market Access ·

2026/06/29

Switzerland's swissdamed database becomes mandatory on July 1, 2026, for all medical devices and IVDs. This episode details the key deadlines, including the transition period until December 31, 2026, for existing devices, the scope of registration for all device classes, and the new annual fee structure based on UDI-DI counts. We provide practical steps for manufacturers to ensure compliance and maintain market access. Key Questions: - What is swissdamed and why is registration becoming

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04:53

UK MHRA International Reliance: Navigating the Draft...

Medical Device Global Market Access ·

2026/06/28

This episode details the UK MHRA's draft Medical Devices (Amendment) Regulations 2026, focusing on the proposed International Reliance pathway. We explore how this new framework aims to streamline market access in Great Britain for devices already approved by regulators in the US, Canada, or Australia. We cover the significance of the stakeholder survey deadline of June 19, 2026, the anticipated entry into force in June 2027, and the practical steps manufacturers should take now to prepare for this

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04:58

Brazil ANVISA Regulatory Reliance: June 2024 Update...

Medical Device Global Market Access ·

2026/06/27

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 with minor issues, the agency will now issue requirement notices, allowing manufacturers to amend their applications. This episode explains how this change de-risks the submission process for Class III and IV medical devices that rely on approvals from Australia, Canada, the U.S., or Japan, making the pathway more efficient and predictable. Key

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04:53

China NMPA Post-Market Vigilance 2026: New Rules for...

Medical Device Global Market Access ·

2026/06/26

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 system that introduces new obligations for foreign medical device manufacturers, including detailed requirements for trend reporting, Periodic Safety Update Reports (PSURs), and comprehensive vigilance planning. Learn about the immediate compliance steps your company must take to maintain market access in China. Key Questions: - What are the

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05:10

Saudi SFDA's 2026 AI Medical App Approval: A Global...

Medical Device Global Market Access ·

2026/06/25

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 signs using a smartphone camera. We break down the technology behind this global first, remote photoplethysmography (rPPG), and explore the innovative regulatory pathways the SFDA used, including its Regulatory Sandbox. This episode details the significant implications for AI and SaMD manufacturers, highlighting why Saudi Arabia is emerging as

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05:10

UK MHRA MDSAP Membership: Streamlining Audits for UK,...

Medical Device Global Market Access ·

2026/06/24

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 significant impact of this decision on medical device manufacturers. We discuss how full membership will streamline the audit process, allowing a single quality management system audit to satisfy requirements for the UK, US, Canada, Australia, Brazil, and Japan. We also cover the strategic implications for the UK's post-Brexit regulatory

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04:48

Singapore HSA COVID-19 IVD Reclassification: Class C...

Medical Device Global Market Access ·

2026/06/23

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 June 2, 2026. This episode details the reasons for this regulatory shift as COVID-19 becomes endemic, explains the differences between Class C and Class D requirements, and outlines the practical impact on technical documentation, quality management systems, and post-market surveillance for IVD manufacturers marketing products in

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05:30

India CDSCO Proposes New Medical Device Import Rules...

Medical Device Global Market Access ·

2026/06/22

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 scanners. This episode explores the potential policy shift, which aims to bypass the traditional licensed importer route to speed up access to advanced technology. We cover the implications for international manufacturers, the patient safety and post-market surveillance concerns raised by domestic industry, and the practical steps regulatory

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04:40

Health Canada's 2026 Hyperbaric Chamber Warning:...

Medical Device Global Market Access ·

2026/06/21

Health Canada issued a public advisory on June 16, 2026, warning that unauthorized soft-shelled hyperbaric chambers are illegal to sell, import, or advertise in Canada. This episode breaks down the specific health risks identified, the regulatory status of these devices, and the enforcement actions being taken. We provide practical compliance steps for manufacturers and distributors of wellness devices to ensure their products meet Canadian regulations and avoid similar enforcement actions.Key

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04:57

Health Canada MDEL Regulations 2026: What Importers...

Medical Device Global Market Access ·

2026/06/20

Health Canada has finalized amended regulations for its Medical Device Establishment Licence (MDEL) framework, which come into force on December 14, 2026. This episode breaks down the critical changes, including the removal of the MDEL requirement for foreign distributors who sell through a licensed Canadian importer and the new obligation for Canadian MDEL holders to provide a complete list of their suppliers. We explore the practical impact on foreign manufacturers, Canadian importers, and

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05:13

FDA AI Software Classification 2026: Class II and...

Medical Device Global Market Access ·

2026/06/19

On June 17, 2026, the US FDA finalized a new Class II classification for radiological machine learning-based quantitative imaging software. This episode breaks down the new rule, explaining how the inclusion of a Predetermined Change Control Plan (PCCP) creates a more streamlined process for future algorithm updates. We detail the specific device types affected and the special controls manufacturers must now implement, offering practical steps for regulatory and quality teams to adapt their

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04:57

Brazil ANVISA SaMD Regulation Update: Preparing for...

Medical Device Global Market Access ·

2026/06/18

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 Device (SaMD), RDC 657/2022. This episode explores the reasons for the update, the potential changes manufacturers can expect regarding AI/ML validation and cybersecurity, and the practical steps regulatory affairs and quality teams should take now to prepare for the upcoming public consultations and new requirements.Key Questions: - What are

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04:50

Singapore HSA's 2026 Medical Device Grouping...

Medical Device Global Market Access ·

2026/06/17

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 detailed analysis of the key changes, including stricter criteria for device families, new requirements for systems and procedure packs, and the direct impact on manufacturers' registration strategies, costs, and timelines in Singapore. We outline the mandatory effective dates and provide practical steps for regulatory teams to ensure compliance

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05:11

Australia TGA UDI Deadline: Class III & IIb Device...

Medical Device Global Market Access ·

2026/06/16

Australia's Therapeutic Goods Administration (TGA) is enforcing its first major Unique Device Identification (UDI) deadline on July 1, 2026. This episode details the critical compliance steps for manufacturers and sponsors of Class III and Class IIb implantable medical devices. We cover the dual requirements for applying a UDI carrier to labels and submitting comprehensive device data to the Australian UDI Database (AusUDID). Learn the practical actions your team must take now to avoid market access

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05:28

Japan PMDA SaMD Guidance: Key Changes from the June...

Medical Device Global Market Access ·

2026/06/15

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 breaks down the key changes, including new requirements for AI/ML validation, heightened cybersecurity expectations, and clarified classification rules. We explore how these updates will impact regulatory strategies, submission timelines, and what practical steps SaMD manufacturers should take to ensure compliance and successful market access in

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05:09

FDA AI Medical Device Guidance 2026: New Rules for...

Medical Device Global Market Access ·

2026/06/14

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 requirements for algorithm transparency, data provenance, risk management, and real-world performance monitoring. We discuss how these changes impact pre-market submissions and post-market obligations for manufacturers and highlight the critical opportunity to provide feedback before the public comment period closes on August 5, 2026.Key

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05:13

FDA Payor Communications Guidance 2026: What Medical...

Medical Device Global Market Access ·

2026/06/13

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 episode breaks down how the guidance extends the safe harbor for sharing Healthcare Economic Information (HCEI) to medical devices and incorporates the Pre-Approval Information Exchange (PIE) Act. We discuss the practical implications for market access, what constitutes 'competent and reliable scientific evidence,' and the steps regulatory and

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05:08

FDA 510(k) Exemption for Unclassified Devices: New...

Medical Device Global Market Access ·

2026/06/12

The US FDA has released a new final guidance, effective June 4, 2026, exempting certain unclassified medical devices from 510(k) premarket notification. This episode explains what 'unclassified devices' are, how this policy streamlines their market access pathway, and the specific actions manufacturers should take to leverage this change while remaining compliant with FDA's General Controls.Key Questions: - What are 'unclassified' medical devices under FDA regulations? - Which specific device

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04:35

EU AI Act & Medical Devices: Deadline Extended to...

Medical Device Global Market Access ·

2026/06/11

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 provisional agreement on the Digital Omnibus package has postponed the application date by two years to August 2, 2028. This episode explores what this delay means for manufacturers, how it impacts compliance strategies, and the practical steps regulatory and quality teams should take to prepare for the eventual implementation.Key Questions: - What

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