How to Evaluate an IVD Rapid Test Supplier

1. Regulatory & certification

• CE marking (EU IVDR) — which product lines, certificate number and scope
• ISO 13485 QMS certificate — issuing body and validity
• FDA 510(k) / NMPA registration where relevant to your market
• Free Sale Certificate (FSC)

2. Product documentation

• IFU (instructions for use) and datasheet per product
• Sensitivity / specificity / cross-reactivity validation data
• Stability and shelf-life data, storage conditions

3. Sample & lot evaluation

• Request samples and validate against your reference method
• Confirm batch-to-batch (lot-to-lot) consistency
• Check packaging, labeling and cut-off alignment to your regulatory standard

4. OEM/ODM & supply

• MOQ and lead time
• Private label / custom panel capability
• Registration support documents (CE files, validation)
• Export documentation (COA, shipping, dangerous-goods where applicable)

What documents should I request from an IVD supplier? IFU, datasheet, certificates (ISO 13485, CE), validation report and stability data.