IVD & Lab Instruments

FDA Tightens IVD Import Filing for UDI-DI and e-Labels

FDA Tightens IVD Import Filing for UDI-DI and e-Labels: learn how the new rule affects customs clearance, labeling workflows, inventory turnover, and U.S. market access for IVD exporters.

EU IVD Rule 2026/1345 Tightens Classification Timeline

EU IVD Rule 2026/1345 tightens classification timeline, moving many Class A products to Class B. Learn the compliance impact on CE certificates, technical files, and EU market access.

FDA Sets eLabel Rule for IVD Imports

FDA Sets eLabel Rule for IVD Imports: learn how the new FDA eLabel Portal requirement from Oct 1, 2026 will impact IVD importers, exporters, labeling workflows, and customs compliance.

EU IVDR Guide Shifts Importer Checks From Formality to Duty

EU IVDR Guide update: importer checks now shift from formality to duty. Learn how stricter verification, records, and supplier review will impact IVD shipments, contracts, and EU market access.

How to Evaluate Throughput and Test Menu in Automated In Vitro Diagnostic Equipment

Automated in vitro diagnostic equipment evaluation starts with real lab workload. Learn how to assess throughput, test menu, STAT handling, and hidden bottlenecks for smarter procurement.

FDA更新IVD进口商QMS合规要求

FDA updates IVD importer QMS compliance requirements: from Oct 1, 2026, validated QMS declarations and technical files must be ready before first import. Learn the key trade, contract, and customs impacts.

EU Tightens IVD Importer QMS Checks From Oct. 1, 2026

EU Tightens IVD Importer QMS Checks From Oct. 1, 2026. Learn how new IVDR importer QMS verification rules may affect batch records, CE files, distributors, and market access.

FDA Tightens IVD Importer Duties From Sept. 2026

FDA Tightens IVD Importer Duties From Sept. 2026: learn how new QSR 21 CFR Part 820 declarations, U.S. Agent filing, and remote audits may impact IVD exports, customs timing, and distributor compliance.

EU IVD Transition Deadline Moved to March 2027

EU IVD Transition Deadline moved to March 2027: learn how the new IVDR timeline, clinical evidence template, and UDI database rules affect CE certification planning.

FDA Mandates Electronic UDI Filing for IVD Exports

FDA Mandates Electronic UDI Filing for IVD Exports: learn how the new FURLS rule impacts registration, customs clearance, labeling, and distributor inventory for U.S.-bound IVD shipments.