Get lab reagents and equipment validated before sale
Kenya Medical Laboratory Technicians and Technologists Board · sources read 3 Oct 2026
Before selling lab reagents or equipment in Kenya, the manufacturer or its local distributor applies to KMLTTB (Form A) with a sample from every batch and a product dossier. KMLTTB validates them and issues a certificate of validation.
- Fee
- We couldn't confirm a fee from the official page. Check it there before you pay.
- Where
- KMLTTB offices, ACK Garden House, Block A, 4th Floor, 1st Ngong Avenue, Nairobi. KMLTTB lists approved suppliers and reagents at kmlttb.org/validation.
What you need
- Application in Form A with a sample from every batch
- Product dossier showing the reagent or equipment meets the safety and performance principles
- Any extra information or samples KMLTTB asks for
Steps
- Work out the product's risk class: A (lowest) to D (highest, such as HIV and blood donor screening).
- Apply to KMLTTB in Form A, with a sample from every batch and the product dossier.
- KMLTTB has an accredited lab test the product against its criteria.
- If it passes, KMLTTB issues a certificate of validation (Form B) and gives the product a GMDN code.
Watch out
- Answer KMLTTB's queries quickly. If you don't respond within three months, the application is rejected.
- Local distributors must have a new product validated and registered within 3 to 6 months of approval, and before importing it.
- Missing the annual fees gets the product removed from KMLTTB's database, and you'll need a fresh approval before you can supply it again.
Who can apply
- Manufacturers, or local distributors, importers and vendors acting for the manufacturer.
- A local distributor must be a company registered in Kenya and authorised by the manufacturer.
Official sources (4)
- Validation of Medical Laboratory Reagents and Equipment (protocol) kmlttb.org · read 3 Oct 2026
- Medical Laboratory (Equipment and Reagents Validation) Standard Operating Procedures (KMLTTB/SOP.VALID/01, May 2024) kmlttb.org · read 3 Oct 2026
- KMLTTB Approved Reagents and Equipments Suppliers kmlttb.org · read 3 Oct 2026
- KMLTTB Service Charter kmlttb.org · read 3 Oct 2026