Medical Device Global Market Access
449 episodes — Page 2 of 9
Health Canada MDEL Modernization: Preparing for Phase 2 Changes by December 2026
Aug 12, 20265 min
EU AI Act and Medical Devices: New Compliance Deadline of August 2, 2028
Aug 11, 20265 min
China NMPA's 57 New Medical Device Guidelines: Immediate Impacts for Manufacturers
Aug 10, 20264 min
FDA Human Factors Guidance 2026: Navigating New eSTAR Requirements
Aug 9, 20265 min
ANVISA Chile ISP Cooperation: Preparing for Latin American Regulatory Convergence
Aug 8, 20264 min
FDA Human Factors Guidance 2026: What 510(k) and PMA Teams Need to Know
Aug 7, 20265 min
FDA Non-Device Software Functions: Public Input Deadline for 2026 Report
Aug 6, 20264 min
Mexico COFEPRIS Equivalence Pathway: New Guidance for Medical Device Registration
Aug 5, 20265 min
FDA Guidance on Hemodialysis Blood Tubing Sets: Key 510(k) Changes for July 23, 2026
Aug 4, 20265 min
UK MHRA AI Scribe Guidance: Clarifying Regulatory Status of AI Medical Scribes
Aug 3, 20265 min
SFDA Used Medical Device Resale: New Warning and Compliance Rules in Saudi Arabia
Aug 2, 20265 min
UK MHRA AI Scribe Regulation: New Guidance for Ambient Voice Technology
Aug 1, 20265 min
China NMPA 2026 Guidelines: Navigating 57 New Medical Device Rules
Jul 31, 20265 min
TGA AI Medical Device Regulation: Preparing for 2026-2027 Enforcement in Australia
Jul 30, 20265 min
Malaysia MDA Product Classification: Mandatory Online Submissions by August 2026
Jul 29, 20264 min
FDA's MDUFA VI Draft Commitment Letter: Key Proposals and the August 7 Comment Deadline
Jul 28, 20264 min
South Korea MFDS Proposal for Digital Medical Device Testing: What Manufacturers Need to Know
Jul 27, 20264 min
Saudi Arabia SFDA Medical Device Advertising: New MDS-REQ 8 Requirements for Manufacturers
Jul 26, 20264 min
India's 2026 CDSCO Guidance on Medical Device Software (MDSW): Key Compliance Steps
Jul 25, 20265 min
FDA eMDR System Enhancements 2026: A Guide for Medical Device Manufacturers
Jul 24, 20265 min
China NMPA Draft GMP Inspection Guideline: Risk-Based Audits and Critical Check Items
Jul 23, 20265 min
ANVISA Medical Device Regulation 2026: Brazil and Chile's Technical Exchange and Its Impact
Jul 22, 20264 min
ANVISA Technovigilance Changes in Brazil: What to Expect After the Public Consultation
Jul 21, 20264 min
South Korea Medical Device Act 2026: MFDS QMS and Distribution Rule Changes
Jul 20, 20264 min
Saudi Arabia SFDA Risk Communication Guidance: What MDS-G-029 Means for Manufacturers
Jul 19, 20265 min
Health Canada Ministerial Reliance Order: Faster Market Access for Medical Devices
Jul 18, 20264 min
UK MHRA Draft Medical Device Regulations 2026: Key Changes and Timeline
Jul 17, 20265 min
EU REP Symbol Transition: Compliance Guide for Medical Device Labeling by 2031
Jul 16, 20265 min
Saudi Arabia SFDA Medical Device Bundling: Key Changes in Guidance MDS-G-028
Jul 15, 20265 min
Australia TGA UDI Requirements: High-Risk Device Compliance by July 1, 2026
Jul 14, 20264 min
EU MDR Well-Established Technologies (WET) Exemption: New Rules for Class III and IIb Devices
Jul 13, 20265 min
China NMPA BCI Classification Guidance: A New Framework for Neurotech Devices
Jul 12, 20265 min
FDA MDUFA VI Reauthorization: What to Expect for FY 2028-2032
Jul 11, 20265 min
Brazil's New e-Notivisa System: ANVISA's Overhaul of Medical Device Adverse Event Reporting
Jul 10, 20264 min
Brazil ANVISA Regulatory Reliance: IN 290/2024 Changes for Class III & IV Devices
Jul 9, 20264 min
EU MDCG 2026-4: SSCP Upload to EUDAMED for Class III & Implantable Devices
Jul 8, 20265 min
China NMPA Innovative Device Approvals Accelerate: Market Access in 2026
Jul 7, 20264 min
Australia's TGA UDI System: Preparing for the July 1, 2026 High-Risk Device Deadline
Jul 6, 20264 min
Japan PMDA SaMD Guidance 2026: AI/ML, Cybersecurity, and Classification Changes
Jul 5, 20265 min
India CDSCO Proposes Faster Medical Device License Timelines
Jul 4, 20265 min
South Korea Medical Device Act 2026: MFDS QMS and Distribution Changes
Jul 3, 20265 min
FDA AI Medical Device Draft Guidance 2026: Lifecycle Management and Submission Requirements
Jul 2, 20265 min
Health Canada MDEL Modernization Phase 2: 2026 Changes for Importers and Distributors
Jul 1, 20265 min
Australia TGA Classification Rule 5.5: Reclassification Changes for Medical Devices
Jun 30, 20265 min
Switzerland's Swissdamed: Mandatory Device and IVD Registration by July 2026
Jun 29, 20264 min
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