What Documents Should Distributors Request for Infectious Disease Rapid Tests?

Infectious disease rapid tests require a more disciplined document review than a general consumer product. A distributor should build a product-specific file before discussing registration, tenders or commercial launch. The exact requirements depend on the disease target, intended use, risk classification and destination country.

1. Manufacturer and quality-system documents

Request the legal manufacturer name and address, applicable quality-management certificates and relevant audit or supplier-assessment information. Confirm certificate scope, issuing organization, validity and whether it covers the manufacturing activity involved.

A company-level ISO 13485 certificate does not prove that every product has the same market authorization. Keep company-system evidence separate from product-specific evidence.

2. Product identification and specifications

The file should clearly identify the product name, catalog number, analyte or target, format, specimen type, kit components, storage conditions, shelf life and intended user. The distributor should be able to match the quotation, sample, packaging and documents to the same version.

For infectious disease portfolios, avoid using a single generic specification for multiple assays unless the manufacturer has explicitly documented the relationship.

3. Performance and technical evidence

Ask which performance documents are available for the exact product. Depending on market and product, this may include analytical and clinical performance information, stability evidence, risk-management documentation and labeling support. Access may be staged or subject to confidentiality.

Do not convert internal study summaries into public marketing claims without regulatory review. Tender requirements may also request specific evidence formats.

4. Labeling and packaging file

Review the pouch, box, label and instructions for use as one controlled package. Check product name, lot number, expiry, storage, symbols, language, manufacturer information, warnings and interpretation statements. Confirm who approves translations and retains final artwork.

For private label, the regulatory roles of the manufacturer, brand owner, importer and authorized representative must be defined for the target market.

5. Registration and shipment documents

Request a destination-specific list rather than assuming CE or another certificate is sufficient everywhere. The EU IVDR applies a risk-based framework and more detailed performance and conformity requirements. Other countries may require local registration, legalization, free-sale evidence or importer documentation.

For each shipment, agree which commercial and quality records will be supplied, such as invoice, packing list, batch-related record or certificate of analysis where applicable.