How to Evaluate an IVD Rapid Test Supplier
Direct answer: Evaluating an IVD supplier means verifying certificates, documentation, stability data and OEM capability before committing to volume.
A practical checklist for distributors, importers and procurement teams.
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)
Request samples, IFU and datasheets →
By Progene Bio Regulatory Affairs Team · Medical Device QA · Medical disclaimer · Last reviewed: 2026-09-12