Medical Device Registration Pricing
Transparent per-family pricing for PPB Class A medical device registration in Kenya. We register by device family - not per SKU - which is the single biggest cost lever for a multi-product range.
PPB Class A Registration
Bundled per-device-family service fee
Plus KES 15,000-20,000 PPB statutory fee per family (paid directly to PPB at cost).
Bundle includes
- Device classification and family / risk-class grouping for the SKU range
- Dossier review and gap analysis (ISO 13485, FSC, IFU, labels, DoC)
- PPB PRIMS portal submission under our account
- One standard round of query response with the PPB Medical Devices Department
- Local Technical Representative (LTR) representation for foreign manufacturers
- Certificate retrieval and hand-over
Add-on
Additional Query Round
KES 10,000 / family / round
Only if PPB requests further clarifications beyond the first round.
Statutory pass-through
PPB Registration Fee
KES 15,000-20,000 / family
Paid directly to PPB at cost; subject to the Finance Act in force at submission.
Indicative Project Totals
Family count is set after a quick review of your full SKU list. Most ranges collapse into 10-20 families.
Lean grouping
KES 450K
10 device families · our fee
+ KES 150K-200K PPB pass-through
Standard grouping
KES 675K
15 device families · our fee
+ KES 225K-300K PPB pass-through
Conservative grouping
KES 900K
20 device families · our fee
+ KES 300K-400K PPB pass-through
Out of scope (typically Client-managed)
This pricing covers PPB Class A registration only. Importation and clearance work is normally handled by the client or their freight partner. We can quote any of the below as a separate scope on request:
- KenTrade / TradeNet account onboarding and IDF processing
- PPB import permits per shipment
- KEBS Pre-Export Verification of Conformity (PVoC) and CoC
- Customs entry, clearing-agent liaison and shipment release
- Logistics, freight, duty and VAT settlement
Frequently Asked Questions
What counts as a "device family"?
A device family groups models that share intended use, risk profile, materials, and design. For surgical instruments, all manual cutting instruments in a range can usually sit in one family; forceps in another; retractors in another. Most multi-SKU ranges collapse into 10-20 families.
Is the KES 45,000 fee per SKU?
No. It is per family. PPB Class A registration is by family / risk-class group, not per SKU - that's the main cost lever for ranges with many models. We do the family review for you as part of the engagement.
What if my device is Class B, C, or D?
This bundle is sized for Class A. Higher classes need additional technical evidence and more extensive PPB review - quoted per project once we've classified the device. Use the free classifier to find your provisional class first.
What are the payment terms?
70% upfront on project initiation; 30% on PPB submission of the final family in scope. Additional query-response rounds are invoiced as and when triggered. PPB statutory fees are passed through at cost against receipts.
How long does registration take?
First family registered end-to-end in roughly 5-7 weeks from kick-off, assuming a complete dossier and one PPB query round. Additional families run in parallel with limited extra time.
Ready to scope your registration?
Share your SKU list and we'll come back with a family count, a fixed fee, and a timeline.