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Executive Insights
- May 11, 2026Vietnam Mandates VN-EMR Interoperability for Imported Diagnostic Devices from Aug 2026Vietnam mandates VN-EMR interoperability for imported diagnostic devices from Aug 2026—key for exporters, firmware devs & cert providers. Act now!Posted by:Medical Device Expert
- May 11, 2026FDA Urgently Revises 510(k) Pathway for AI-Enhanced Rehab DevicesFDA urgently revises 510(k) pathway for AI-enhanced rehab devices — new algorithm validation & diverse dataset rules impact Chinese exporters now.Posted by:Medical Device Expert
- May 10, 2026JIS T 0601-2-77:2026 Enforces 300% EMC Immunity Increase for Medical Diagnostic DevicesJIS T 0601-2-77:2026 mandates 300% higher EMC immunity (30 V/m) for medical diagnostic devices—act now to avoid Japanese market exclusion.Posted by:Medical Device Expert
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