PPB Fees Kenya / Medical devices
Medical devices: PPB fees, timelines and our charges
PPB registration of medical devices by risk class (A, B, C, D) and in-vitro diagnostics.
Medical devices are registered by risk class. Class A is the lowest risk and Class D the highest, and the class drives both the government fee and the documentation required. In-vitro diagnostics (IVDs) follow the same framework.
Where a device is already cleared by a recognised regulator such as the US FDA or carries a CE mark, the PPB abridged or reliance route can shorten the review. Foreign manufacturers appoint us as their Local Technical Representative.
Government (PPB) fees
Statutory charges paid to the PPB, passed through at cost when we act for you.
| Item | Fee |
|---|---|
| Class A registration or renewal | USD 100 |
| Class B registration or renewal | USD 200 |
| Class C registration or renewal | USD 1,000 |
| Class D registration or renewal | USD 1,000 |
| Emergency Use Authorization (device or IVD) | USD 2,500 |
Our professional charges
From USD 300 per device
Indicative, quoted by risk class and portfolio size. Single-device engagements and higher-risk devices (Class C, Class D, IVD) are quoted higher, and a one-time LTR or establishment setup applies for foreign manufacturers. Confirming the correct class early is the biggest lever on cost.
Fees are indicative and open to discussion for the right fit, with volume and portfolio discounts by quote. Government fees are separate and billed at cost.
Request a quoteHow long registration takes
With reliance on a recognised approval (US FDA, CE), typically 3 to 6 months. A full assessment without reliance takes longer.
When renewal is due
Registration is generally valid for 5 years; renew before expiry. The renewal fee equals the registration fee for the class. Confirm the exact validity on your certificate.
Checklists for this category
Use these to prepare and gap-check your file before submitting through PRIMS.