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Medical Device Global Market Access

Medical Device Global Market Access

Pure Global

354 episodesEN

Show overview

Medical Device Global Market Access launched in 2025 and has put out 354 episodes in the time since. That works out to roughly 20 hours of audio in total. Releases follow a near-daily cadence.

Episodes typically run under ten minutes — most land between 3 min and 4 min — and the run-time is fairly consistent across the catalogue. None of the episodes are flagged explicit by the publisher. It is catalogued as a EN-language Technology show.

The show is actively publishing — the most recent episode landed 4 weeks ago, with 117 episodes already out so far this year. Published by Pure Global.

Episodes
354
Running
2025–2026 · 1y
Median length
3 min
Cadence
Near-daily

From the publisher

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 veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale. • Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve. • Actionable templates – From clinical evaluation checklists to technical-file skeletons, we break down the documents you’ll need and the pitfalls reviewers love to flag. • AI-powered insights – Because Pure Global mines millions of public filings, tenders, and recalls, we surface data-backed best practices you won’t hear at conferences—or from competitors. What you’ll hear • Launching SaMD under multiple risk classes in parallel • Surviving an unannounced ISO 13485 audit • Building a “reg-first” QMS that scales • Mastering Latin-American registrations without endless language cycles • Leveraging real-world evidence to shorten clinical timelines • Aligning cybersecurity, privacy, and post-market surveillance rules across regions Whether you’re plotting first entry, managing lifecycle expansions, or rescuing a delayed submission, subscribing could shave months—and millions—off your path to revenue. ⸻ Brought to you by Pure Global – the AI-native consultancy that already guides MedTech innovators through regulatory and market-access hurdles in 30 + countries. Ready for expert help on your next submission? Visit https://pureglobal.com or email [email protected] to start accelerating today.

Latest Episodes

View all 354 episodes

UK MHRA International Reliance: Navigating the Draft 2026 Medical Device Regulations

Jun 28, 20264 min

Brazil ANVISA Regulatory Reliance: June 2024 Update to IN 290/2024 Streamlines Class III/IV Device Review

Jun 27, 20264 min

China NMPA Post-Market Vigilance 2026: New Rules for Foreign Manufacturers

Jun 26, 20264 min

Saudi SFDA's 2026 AI Medical App Approval: A Global First for Vital Signs Monitoring

Jun 25, 20265 min

UK MHRA MDSAP Membership: Streamlining Audits for UK, US, Canada, and More

Jun 24, 20265 min

Singapore HSA COVID-19 IVD Reclassification: Class C Requirements from 2026

Jun 23, 20264 min

India CDSCO Proposes New Medical Device Import Rules for Hospitals (2026)

Jun 22, 20265 min

Health Canada's 2026 Hyperbaric Chamber Warning: Compliance for Unlicensed Devices

Jun 21, 20264 min

Health Canada MDEL Regulations 2026: What Importers and Foreign Manufacturers Need to Know

Jun 20, 20264 min

FDA AI Software Classification 2026: Class II and PCCP Rules for Imaging Devices

Jun 19, 20265 min

Brazil ANVISA SaMD Regulation Update: Preparing for Changes to RDC 657/2022

Jun 18, 20264 min

Singapore HSA's 2026 Medical Device Grouping Guidance: Key Changes in GN-12-1-R3

Jun 17, 20264 min

Australia TGA UDI Deadline: Class III & IIb Device Compliance by July 1, 2026

Jun 16, 20265 min

Japan PMDA SaMD Guidance: Key Changes from the June 2026 Update

Jun 15, 20265 min

FDA AI Medical Device Guidance 2026: New Rules for Transparency and Lifecycle Management

Jun 14, 20265 min

FDA Payor Communications Guidance 2026: What Medical Device Manufacturers Need to Know

Jun 13, 20265 min

FDA 510(k) Exemption for Unclassified Devices: New June 2026 Guidance

Jun 12, 20265 min

EU AI Act & Medical Devices: Deadline Extended to 2028 for High-Risk Systems

Jun 11, 20264 min

FDA 510(k) Exemption Guidance 2026: Five New Product Codes Exempted

Jun 10, 20264 min

China NMPA's New Dynamic Medical Device Classification: What Manufacturers Need to Know

Jun 9, 20264 min
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