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 regimes, showing exactly how long each milestone really takes and where companies get stuck. • First-hand war stories – Hear candid interviews with regulatory...
Latest episodes
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6 min
China NMPA GMP Inspection Guideline: Preparing for the November 1, 2026 Deadline
China's NMPA has released its final Good Manufacturing Practice (GMP) inspection guideline, which becomes mandatory on November 1, 2026. This episode provides a detailed breakdown…
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5 min
China NMPA GMP 2026: Preparing for Stricter Quality System Requirements
China's National Medical Products Administration (NMPA) is enforcing a revised Good Manufacturing Practice (GMP) for medical devices starting November 1, 2026. This episode provide…
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5 min
Indonesia Halal Certification for Class A Medical Devices: The October 18, 2026 Deadline
Indonesia is implementing mandatory Halal certification for Class A medical devices, with a critical deadline of October 18, 2026. This episode breaks down what the Halal Product A…
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4 min
Swissmedic swissdamed Importer Linking: April 1, 2027 Deadline for Medical Device Importers
Swissmedic has activated the importer linking function in the swissdamed database as of October 1, 2026. This creates a new mandatory step for Swiss importers, who now have until A…
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5 min
EU Joint Clinical Assessment: First High-Risk Medical Devices Selected Under HTAR
On October 6, 2026, the European Commission selected the first group of high-risk medical devices to undergo a Joint Clinical Assessment (JCA) under the new EU Health Technology As…
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5 min
Australia TGA Medical Device Fee Changes: What to Know for 2026 Audits
Australia's Therapeutic Goods Administration (TGA) has updated its guidance on fee reductions for medical device conformity and ARTG application audits. Effective October 1, 2026,…
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5 min
TGA AI Medical Scribe Regulation: When Clinical Software Becomes a Medical Device
Australia's Therapeutic Goods Administration (TGA) has clarified that many AI-powered digital scribes are considered medical devices, not simple administrative tools. Following a r…
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5 min
Japan PMDA Generative AI Guidance: Key Review Points for Medical Device Manufacturers
On October 14, 2026, Japan's PMDA published its draft guidance, 'Review Points for Medical Devices Utilizing Generative AI.' This episode explores the key safety and performance ev…
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5 min
Health Canada Medical Device Shortage Guidance: Exceptional Importation and Sale Updates
Health Canada has released revised guidance on its framework for exceptional importation and sale of medical devices, effective October 16, 2026. This episode details the key clari…
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6 min
FDA Draft Guidance for Robotically Assisted Surgical Devices: Premarket Submission Insights
On October 9, 2026, the US FDA issued new draft guidance clarifying premarket submission requirements for robotically assisted surgical (RAS) devices. This episode breaks down the…
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5 min
FDA GenAI Medical Device Regulation: Key Considerations Before the October 19, 2026 Comment Deadline
The US FDA is considering a new 'total product lifecycle' approach for regulating medical devices that use Generative AI (GenAI). This episode breaks down the key elements of the F…
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5 min
Singapore HSA-ACE Priority Track: Faster Market Access for Innovative Medical Devices
Singapore's Health Sciences Authority (HSA) has announced a new priority pathway for innovative medical devices, launching in November 2026. The 'HSA-Agency for Care Effectiveness…
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5 min
South Korea MFDS Proposes Faster Class II Medical Device Certification
South Korea's Ministry of Food and Drug Safety (MFDS) has proposed a new one-stop certification and technical review process for Class II medical devices. This episode breaks down…
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4 min
Brazil ANVISA SaMD & AI Vigilance Rules: Mid-October 2026 Feedback Deadline
Brazil's ANVISA has launched Public Call No. 4/2026 to revise its Tecnovigilância (post-market vigilance) framework, specifically seeking industry feedback on the challenges posed…
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5 min
FDA 510(k) Exemption for Clinical Toxicology Devices: What IVD Makers Need to Know
The US FDA issued a final order on October 5, 2026, exempting certain Class II clinical toxicology test systems from 510(k) premarket notification requirements. This episode breaks…
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5 min
India's Revised Materiovigilance (MvPI) Guidelines: Expanded Scope for Software, AI, and Cybersecurity
India has significantly overhauled its medical device safety monitoring framework. Effective October 9, 2026, the revised Materiovigilance Programme of India (MvPI) guidelines now…
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5 min
Australia TGA Proposes Greater Medical Device Transparency: What Sponsors Need to Know
This episode explores the Australian Therapeutic Goods Administration (TGA)'s recent consultation on increasing the public sharing of medical device information, which closed on Oc…
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5 min
UK MHRA AI Medical Device Rules: What the New Lifecycle Framework Means for Manufacturers
The UK government has committed the MHRA to a new lifecycle-based regulatory framework for AI-enabled medical devices, moving away from one-time pre-market assessments to continuou…
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6 min
UK MHRA AI Medical Device Regulation: New Lifecycle Approach and AI Airlock Phase 3
The UK government has accepted all 44 recommendations for regulating AI in healthcare, marking a major policy shift for the MHRA. As of October 6, 2026, the UK is moving from a sin…
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5 min
China NMPA's Revised GMP: What Manufacturers Must Do by the November 2026 Deadline
China's National Medical Products Administration (NMPA) is enforcing a revised Good Manufacturing Practice (GMP) for medical devices, with a compliance deadline of November 1, 2026…