Medical Device Global Market Access
448 episodes — Page 1 of 9
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FDA's New PMA Electronic Submission Template: Draft Guidance Explained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
Australia TGA Device Classification Rules: Saline Flush Syringes Reclassified to Class IIa
Sep 10, 20264 min
China NMPA Approves LEQEMBI Autoinjector: A Signal for Drug-Device Combination Products
Sep 9, 20264 min
Brazil ANVISA High-Risk Device Registration: Public Consultation No. 1,248 Explained
Sep 8, 20265 min
Brazil ANVISA's New Notification Guidance: What Class I/II Medical Device and IVD Manufacturers Need to Know
Sep 7, 20265 min
Singapore HSA's New Registration Pathway for Special Access Route (SAR) Devices
Sep 6, 20265 min
UK MHRA Health Bill Amendments 2026: New Powers for Future Device Regulation
Sep 5, 20264 min
UK MHRA's New Licensing Powers: What the 2026 Health Bill Amendments Mean for Medical Device Manufacturers
Sep 4, 20265 min
UK MHRA Non-Compliant Devices: DSI/2026/007 and Supply Chain Risks
Sep 3, 20265 min
Australia TGA Consultation on Medical Device Information Sharing: What Sponsors Need to Know
Sep 2, 20264 min
Health Canada Special Access Program: New Application Process for Medical Devices
Sep 1, 20265 min
UK MHRA ResMed Astral Alert: Ventilator Safety Actions for NatPSA/2026/004/MHRA
Aug 31, 20264 min
China NMPA Medical Device Approval: Analyzing the August 12, 2026 Batch
Aug 30, 20265 min
Singapore HSA's New Medical Device Cybersecurity Guide (GL-10-R1): Key Principles and Actions
Aug 29, 20265 min
COFEPRIS Medical Device Sanitary Registry Viewer: What Manufacturers Need to Know
Aug 28, 20265 min
India CDSCO Amends Sterilization Rules: What Removing the Loan Licence Means for Medical Devices
Aug 27, 20264 min
EU Notified Body Shake-Up: What the NSAI and TÜV NORD Exits Mean for MDR Certification
Aug 26, 20264 min
Japan PMDA Workshop: A Guide to Medical Device Market Entry for U.S. Firms
Aug 25, 20265 min
UK MHRA Rectal Catheter Alert: Infant Safety and Post-Market Lessons
Aug 24, 20264 min
Brazil ANVISA Innovative Device Pilot Program 2026: A Guide for High-Risk MedTech
Aug 23, 20265 min
SFDA Biocompatibility Requirements: Preparing Medical Device Submissions for Saudi Arabia
Aug 22, 20264 min
FDA Discussion Paper on Generative AI in Medical Devices: Feedback Deadline and Key Considerations
Aug 21, 20265 min
FDA Proposed Rule on Class I Accessories: 2026 Changes for 510(k) Exemption
Aug 20, 20264 min
Saudi Arabia SFDA Medical Device Advertising Rules: MDS-REQ 8 Compliance for Manufacturers
Aug 19, 20265 min
CMS RAPID Coverage Pathway: Breakthrough Device Reimbursement Changes
Aug 18, 20265 min
Australia TGA Suspends Corpuls Defibrillators: What It Means for Post-Market Compliance
Aug 17, 20265 min
MHRA National Alert DSI/2026/007: Quarantining Devices Without UKCA or CE Marks
Aug 16, 20266 min
MHRA Non-Compliant Medical Devices: UK Quarantine Order and Supply Chain Lessons
Aug 15, 20265 min
FDA MDUFA VI Fees: Proposed Increases for Overseas Manufacturers
Aug 14, 20264 min
India's Draft Drugs, Medical Devices and Cosmetics Bill 2026: Key Changes for Manufacturers
Aug 13, 20264 min
Health Canada MDEL Modernization: Preparing for Phase 2 Changes by December 2026
Aug 12, 20265 min