Product Technical Documentation (Most critical for overseas registration, common pitfall for overseas distributors)
Technical File (TF), risk analysis document.
Performance evaluation report: sensitivity, specificity, precision, stability, interference test.
Stability data: accelerated stability, real-time shelf life, shipping simulation stability (critical for tropical countries).
IFU, labels and packaging design files in multi-language versions.
Clinical evaluation data; judge whether supplementary clinical data is required per target country registration requirements.
