TheBitCast

Medical Device Global Market Access

Autor: Pure Global

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...

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  1. Indonesia Halal Certification for Class A Medical Devices: The October 18, 2026 Deadline – Medical Device Global Market Access
  2. Swissmedic swissdamed Importer Linking: April 1, 2027 Deadline for Medical Device Importers – Medical Device Global Market Access
  3. EU Joint Clinical Assessment: First High-Risk Medical Devices Selected Under HTAR – Medical Device Global Market Access
  4. Australia TGA Medical Device Fee Changes: What to Know for 2026 Audits – Medical Device Global Market Access
  5. TGA AI Medical Scribe Regulation: When Clinical Software Becomes a Medical Device – Medical Device Global Market Access
  6. Japan PMDA Generative AI Guidance: Key Review Points for Medical Device Manufacturers – Medical Device Global Market Access
  7. Health Canada Medical Device Shortage Guidance: Exceptional Importation and Sale Updates – Medical Device Global Market Access
  8. FDA Draft Guidance for Robotically Assisted Surgical Devices: Premarket Submission Insights – Medical Device Global Market Access
  9. FDA GenAI Medical Device Regulation: Key Considerations Before the October 19, 2026 Comment Deadline – Medical Device Global Market Access
  10. Singapore HSA-ACE Priority Track: Faster Market Access for Innovative Medical Devices – Medical Device Global Market Access
  11. South Korea MFDS Proposes Faster Class II Medical Device Certification – Medical Device Global Market Access
  12. Brazil ANVISA SaMD & AI Vigilance Rules: Mid-October 2026 Feedback Deadline – Medical Device Global Market Access
  13. FDA 510(k) Exemption for Clinical Toxicology Devices: What IVD Makers Need to Know – Medical Device Global Market Access
  14. India's Revised Materiovigilance (MvPI) Guidelines: Expanded Scope for Software, AI, and Cybersecurity – Medical Device Global Market Access
  15. Australia TGA Proposes Greater Medical Device Transparency: What Sponsors Need to Know – Medical Device Global Market Access
  16. UK MHRA AI Medical Device Rules: What the New Lifecycle Framework Means for Manufacturers – Medical Device Global Market Access
  17. UK MHRA AI Medical Device Regulation: New Lifecycle Approach and AI Airlock Phase 3 – Medical Device Global Market Access
  18. China NMPA's Revised GMP: What Manufacturers Must Do by the November 2026 Deadline – Medical Device Global Market Access
  19. Health Canada MDEL Amendments 2026: New Rules for Distributors and Importers – Medical Device Global Market Access
  20. Indonesia Halal Certification: Class A Medical Device Deadline on October 17, 2026 – Medical Device Global Market Access
  21. UK MHRA Wireless CTG Safety Alert: Post-Market Actions for Manufacturers – Medical Device Global Market Access
  22. Japan PMDA SaMD Guidance: 2026 Update and Submission Strategy – Medical Device Global Market Access
  23. UK MHRA Patient Hoist Safety Alert: Actions for NatPSA/2026/005/MHRA by September 2026 – Medical Device Global Market Access
  24. SFDA Medical Device Advertising Compliance: Responding to New Enforcement Actions – Medical Device Global Market Access
  25. TGA CDSS Exemption Changes: Preparing for the November 1, 2026 Deadline – Medical Device Global Market Access
  26. Japan PMDA Generative AI: New Draft Criteria for Programmed Medical Devices – Medical Device Global Market Access
  27. FDA Robotic Surgery Guidance: Key Changes for Premarket Submissions – Medical Device Global Market Access
  28. EU EUDAMED SSCP/SSP Upload: MDCG 2026-4 Mandates Manufacturer Responsibility by October 2026 – Medical Device Global Market Access
  29. Brazil ANVISA Medical Device Vigilance: Public Call on SaMD and AI Rules – Medical Device Global Market Access
  30. EU MDCG 2020-16 Rev 5: IVDR Classification for IVD Quality Control Materials – Medical Device Global Market Access