Sourcing diagnostic and lab reagents from China

Zero duty

Read from the UK Trade Tariff on 25 September 2026, diagnostic or laboratory reagents on a backing or prepared, including those for malaria, Zika and other Aedes-borne diseases, blood grouping and other uses, and other reagents and certified reference materials of heading 3822, carried 0% duty on goods from China, with no anti-dumping measure.

Antisera and vaccines are in heading 3002, covered in the vaccines guide. Confirm the commodity code.

In vitro diagnostic rules

Reagents and kits intended for diagnosis are in vitro diagnostic medical devices under the Medical Devices Regulations 2002. They need UKCA or CE marking under the IVD rules, a UK Responsible Person where the maker is overseas, and MHRA registration before being placed on the Great Britain market; see medical products. Reagents for research only must be labelled research use only and not marketed for diagnosis. For the opposite trade direction, see our guide to exporting diagnostic reagents to China.

Worked duty example

Illustrative example, not a quote: 500 diagnostic test kits under 3822 19 00 90, invoiced at £5,000 free on board, with £300 of freight and insurance to the UK. The customs value is £5,300. Duty at 0% is £0. Import VAT at 20% is charged on the customs value plus duty, £5,300, so it is £1,060. With no duty, the only import tax is the VAT, which a VAT-registered importer can usually reclaim. The import duty and VAT guide explains each step.

Inspection checklist

Manufacturer and labelling: confirm the maker holds ISO 13485 certification covering the product, that labels use the symbols of EN ISO 15223-1 with lot number, expiry and storage conditions, and that instructions for use are in English.

Lot release and stability: ask for a certificate of analysis for each lot, the stability study behind the claimed shelf life and in-use stability designed to EN ISO 23640, and the performance evaluation data behind any sensitivity and specificity claim.

Shipping and receipt: agree a minimum remaining shelf life at delivery, ship with temperature loggers set to the storage range, and on receipt check logger data, packaging integrity, kit contents against the component list and the UK Responsible Person and registration details.

What goes wrong

Reagents fail through the cold chain and the paperwork. Enzymes and antibodies lose activity if shipped warm, kits expire in customs if dates are short, and sensitivity and specificity claims that are not backed by a performance evaluation make the product unsaleable as an IVD.

Ask for the performance evaluation or validation data, instructions for use in English, lot-specific certificates and expiry dates with enough remaining life. At inspection, check storage temperature records, labelling and kit completeness.

Cambridge China Bridge sources diagnostic kits and laboratory reagents, with IVD status, cold chain and documents settled before the order. See how our sourcing service works.

Related guides: Sourcing first aid kits and medical sundries.

Related guides: Sourcing microbiological culture media from China. For laboratory filtration supplies, see our laboratory filter paper sourcing guide.