Four routes — pick your lane
IBR (48 hours), expedited (1–3 months), abridged (3–6 months), full evaluation (6–12 months) — the lane follows your foreign approvals.
Free field guide · PDF
Kenya PPB Medical Device Registration2026 Field Guide
Four routes, the reference-agency ladder, and the local-representative rule — with the timeline ladder.
- Fastest route
- 48 hrs
- Expedited route
- 1–3 mo
- Full evaluation
- 6–12 mo
Sourced from PPB guidance and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — PPB guidance and verified 2026 publications.
The reference-agency ladder
2 reference approvals → abridged; 3 → expedited/IBR. Plus the Class A dossier list, ISO 13485, and the facility-audit gate.
The local-representative rule
Foreign applicants appoint a Kenyan local representative — with GMP evidence, home-market authorization, and PPB portal filing.
Sources & scope
- ethiobiomedical.com, medical device registration process in Kenya by PPB.
- pharmacyboardkenya.org, PPB guideline for registration of medical devices.
- kenyalaw.org, Pharmacy and Poisons (Registration of Health Products) Rules.
- standardsalliance-mdrc.org, PPB overview of medical device and IVD regulation.
This guide is market-access intelligence, not regulatory or legal advice. PPB routes, reference-agency criteria, and timelines are product-specific — professional review is required before business use.
Market Access Strategy Session
Kenya on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your PPB route — route selection, reference-agency evidence, and local-representative setup.
Professional review is required before business use.
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