China Medical & Regulatory Intelligence Platform
Statutory regulatory roadmaps and technical evaluation guides for Chinese pharmaceuticals, medical devices, and in-vitro diagnostics: FDA 21 CFR 207, NMPA UDI 2027 mandates, and automated molecular POCT systems.
1. FDA Global Statutory Compliance
Statutory requirements for foreign pharmaceutical establishments registering with the US Food and Drug Administration.
FDA Foreign Drug Establishment Registration Guide
FEI number acquisition, DUNS verification, US Agent statutory requirements, CDER Direct SPL XML submissions, and annual renewal deadlines.
NMPA Medical Device UDI 2027 Mandatory Timeline
Class II and III medical device Unique Device Identification (UDI) implementation deadlines, DI/PI barcode standards, and database submission.
2. Molecular POCT & In-Vitro Diagnostics
Analytical performance validation and cross-border laboratory procurement criteria for fully automated nucleic acid testing systems.
Fully Automated Molecular POCT: iFIND Procurement Guide
Throughput, assay menus (S2/S4/S8), workflow integration, contamination control, and analytical claims validation.
iFIND TBR Tuberculosis & Rifampicin Resistance Cartridge
Clinical sensitivity, limit of detection (LoD CFU/mL), and technical evaluation questions for diagnostic laboratory buyers.
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