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Medical Device Global Market Access

Medical Device Global Market Access

Pure Global

448 episodesEN

Show overview

Medical Device Global Market Access launched in 2025 and has put out 448 episodes in the time since. That works out to roughly 30 hours of audio in total. Releases follow a near-daily cadence.

Episodes typically run under ten minutes — most land between 3 min and 5 min — though episode length varies meaningfully from one episode to the next. 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 yesterday, with 211 episodes already out so far this year. Published by Pure Global.

Episodes
448
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 448 episodes

Japan PMDA Generative AI: New Draft Criteria for Programmed Medical Devices

Sep 30, 20266 min

FDA Robotic Surgery Guidance: Key Changes for Premarket Submissions

Sep 29, 20265 min

EU EUDAMED SSCP/SSP Upload: MDCG 2026-4 Mandates Manufacturer Responsibility by October 2026

Sep 28, 20264 min

Brazil ANVISA Medical Device Vigilance: Public Call on SaMD and AI Rules

Sep 27, 20265 min

EU MDCG 2020-16 Rev 5: IVDR Classification for IVD Quality Control Materials

Sep 26, 20265 min

Brazil ANVISA High-Risk Device Registration: Navigating Public Consultation 1248

Sep 25, 20265 min

UK MHRA Health Bill Amendments: Future of Medical Device Licensing

Sep 24, 20264 min

FDA's New PMA Electronic Submission Template: Draft Guidance Explained

Sep 23, 20264 min

MFDS Korea Post-Market Study Exemption: Leveraging Overseas Data Under Notice 2026-63

Sep 22, 20265 min

Health Canada Exceptional Importation: Navigating the Updated Forms for Medical Device Shortages

Sep 21, 20264 min

China NMPA GMP Inspection Guidance: Preparing for the November 1, 2026 Deadline

Sep 20, 20265 min

FDA Radiology AI Software 510(k) Exemption: Final Order Clarifies Pathways for CADe/CADx Devices

Sep 19, 20265 min

China NMPA BCI Standard: New Rules for AI-Powered Medical Devices

Sep 18, 20265 min

China NMPA Policy on Localizing Imported Medical Device Production

Sep 17, 20264 min

Mexico COFEPRIS Authorized Third Parties: New 4-Year Validity and Operating Guidelines

Sep 16, 20265 min

SFDA AI Medical Software: Market Access in Saudi Arabia After First SaMD Approvals

Sep 15, 20264 min

Australia TGA CDSS Exemption 2026: What SaMD Manufacturers Need to Know

Sep 14, 20265 min

India CBIC Medical Device Import Checklist: New Customs Clearance Requirements

Sep 13, 20265 min

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

Sep 12, 20265 min

SFDA Medical Device Advertising: Responding to Enforcement in Saudi Arabia

Sep 11, 20264 min
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