Kenya Medical Device Fee Schedule: USD Rates, Refunds and Budgeting

Content verified on: October 30, 2026

1. Key takeaways

• Device registration fees are priced in US dollars: Class A USD 100, Class B USD 200, Class C USD 1,000, Class D USD 1,000; renewal fees equal the registration fees.
• General health products programme: registration application not manufactured in Kenya USD 1,000, manufactured in Kenya USD 500; renewal at the same amounts; expedited review USD 2,000; emergency use authorisation for medical devices and IVDs USD 2,500; donations USD 0.
• Table 6 of the Guidelines lists further class-based differences: variation to a registered device, imported USD 200 and locally manufactured USD 50; annual retention, imported Class A and B USD 50, Class C and D USD 300, locally manufactured USD 50.
• Two discrepancies must be presented side by side: the Second Schedule does not list annual retention or variation fees by device class; and the Second Schedule does not distinguish imported versus locally manufactured device registration fees, while the Guidelines do.
• Payment timing is rigid: the application fee is paid at submission and the evaluation fee when the application is accepted for evaluation; the application fee is non-refundable once successfully submitted, and the evaluation fee is non-refundable once accepted.
• The charging unit is per class, per manufacturer, per product; amounts accumulate on that basis within a product family.

2. Legal basis

3. Expert insights

Insight 1: Two coexisting references mean the budget can only anchor on actual PRIMS billing

The Second Schedule is a statutory annex and Table 6 of the Guidelines is an operational reference, and they diverge in two places. First, the Second Schedule does not list annual retention or variation fees by A/B/C/D class, which the Guidelines set at USD 50 and USD 300 for retention and USD 200 and USD 50 for variations. Second, the Second Schedule does not distinguish imported from locally manufactured device registration fees, which the Guidelines do. GRZAN judges that budgeting should reserve amounts on the Guidelines reference while cross-checking the actual billed amount in the PRIMS system before payment and treating the system figure as controlling, so that a shortfall caused by the reference gap never delays acceptance.

Insight 2: The non-refund rules convert dossier quality directly into financial cost

The application fee is forfeited once successfully submitted, and the evaluation fee once accepted — whether the application is later withdrawn or refused makes no difference. The substance of this rule is to turn dossier completeness into direct cost: a single refusal caused by documentation defects forfeits the full application fee plus the evaluation fee. GRZAN recommends one internal pre-review before submission, aligned with the change classification in article 30 and the CSDT module list; its cost is trivial compared with a single refusal.

Insight 3: The local manufacturing rate advantage carries a policy signal

Table 6 of the Guidelines shows locally manufactured device registration fees at Class A USD 50, Class B USD 50, and Classes C and D USD 100, with annual retention uniformly USD 50 — all below the imported reference. This aligns with the Kenya Local Manufacturing Strategy for Health Products and Technologies 2026–2030 advanced by the Ministry of Health. GRZAN judges that for businesses planning capacity, the rate gap alone is not an investment case, but it is a deterministic variable worth building into medium- and long-term cost models.

Insight 4: The five-year total cost of ownership should be modelled in one pass

Take an imported Class C or Class D product: one full certificate cycle costs at least USD 1,000 for registration, 4 annual retention payments at USD 300 each, USD 1,000 for renewal, plus possible variation fees of USD 200. GRZAN recommends modelling the whole five-year cycle at project initiation and multiplying by the number of product families — because the charging unit is per class, per manufacturer, per product, the number of items within a family scales total spend directly.

4. Practical recommendations

1. Budget on both references. GRZAN recommends building the budget on the Guidelines Table 6 reference while checking the Second Schedule line by line, with notes wherever the two differ.
2. Verify the amount before paying. Log into PRIMS before actual payment to view the system-billed amount and pay on the system figure.
3. Pre-review before submission. Run an internal pre-review checklist aligned with the CSDT module list and the change classification rules to reduce fee losses from refusal.
4. Model by product family. Use the per class, per manufacturer, per product basis and count family items into the total cost model.
5. Phase the cash flow. Plan payments around the two trigger points — the application fee at submission and the evaluation fee at acceptance — to avoid funding misalignment.
6. Archive payment evidence. File the payment receipt and system acknowledgement for every fee by certificate number, as evidence at renewal and inspection.

5. Verification checklist

• □ Does the budget include both the Second Schedule USD pricing and the Guidelines Table 6 reference?
• □ Are the two discrepancies recorded: class-based retention and variation fees, and imported versus local registration fees?
• □ Was the actual PRIMS billed amount checked before payment?
• □ Has the product family total cost been modelled on the per class, per manufacturer, per product basis?
• □ Is it known that the application fee is paid at submission and the evaluation fee at acceptance?
• □ Has the non-refund risk been assessed, with a resubmission budget reserved for a refusal scenario?
• □ Has the five-year cycle cost (registration plus 4 retention payments plus renewal plus variations) been fully modelled?
• □ Are payment receipts and system acknowledgements archived by certificate number?

Regulatory information verified as of October 30, 2026.

In African markets, the GRZAN regulatory team focuses on jurisdictions such as Kenya, Nigeria, South Africa and Egypt and runs a verification mechanism built on primary regulatory sources: every regulatory conclusion it publishes relies solely on official gazettes, the original texts of regulator guidelines and public legal databases, each marked with a verification date. Any figure, timeline or amount that cannot be located in an official source is flagged as a practical estimate rather than an assumption.

GRZAN services cover: market access strategy and risk-classification assessment; preparation and review of registration dossiers (CSDT, STED and CTD formats); selection and management of Local Authorized Representatives (LAR); quality management system and GMP/GSDP compliance coaching; post-market vigilance, change management and recall response; import customs clearance and PVoC coordination; regulatory intelligence subscriptions and corporate compliance ledgers.

For a Kenya market access plan tailored to a specific product, contact the GRZAN regulatory team at info@grzanglobal.com.