· 2 min read
Registering an IVD in Kenya: a practical guide
The steps, documents and parties involved in registering an in-vitro diagnostic with Kenya's Pharmacy and Poisons Board, from CSDT dossier to tenders.
By Grace Wanjũgũ Kamau
Kenya is often the first East African registration for international diagnostics companies. The process is clear once you have seen it end to end. This guide walks through it in order.
1. Who regulates IVDs in Kenya
In-vitro diagnostics are regulated as medical devices by the Pharmacy and Poisons Board (PPB). A product needs PPB registration before it can be sold.
2. The dossier: CSDT
PPB applications use the Common Submission Dossier Template (CSDT). If you already hold a technical file for another market, most of what you need exists. It is usually arranged differently.
A gap analysis comes first. It compares your file with the CSDT and lists what is missing, what needs reformatting and what needs local input.
3. Submission through PRIMS
Applications are submitted through PRIMS, the Board's online portal. Expect questions. Clear, fast answers to regulator queries keep the review moving.
4. In-country performance testing
Some IVDs must be evaluated in a Kenyan laboratory before approval. Plan early for samples, logistics and the time this adds.
5. Import and standards
Kenya Bureau of Standards (KEBS) requirements can apply at import. Check them before the first shipment, not after.
6. Selling after registration
Registration opens the door. Sales come through distributors, private labs and public buying:
- KEMSA buys for national programmes.
- County governments run their own tenders.
- Private hospitals and labs buy through distributors.
A good distributor, tender readiness and relationships with key opinion leaders turn a registration into orders.
Where Tri-Lab Scientific helps
We run the gap analysis, prepare the dossier, manage the submission and coordinate performance testing. After approval, we help you find the right distributor and get ready for tenders.