Change Notification for Registered Devices in Kenya: Categories and Fees

Content verified as of 30 October 2026.

1. Key takeaways

• Kenya divides changes to registered devices into four categories: technical changes, review changes, administrative changes and notification changes.
• The first three all require prior approval; notification changes may be implemented upon receipt of the confirmation email from the online system, unless the change stems from a reportable adverse event or an FSCA.
• Five categories of change are excluded from change notification and require a fresh CSDT submission: change of intended use, change of risk classification, change of device grouping, change of the medicinal substance in a drug-device combination, and adding devices under different proprietary names to the same family listing.
• The consequence of misclassification is not correction but disability: the change application is refused, and the company is prohibited from continuing to supply.
• The fee for changes to registered devices is USD 200 (Table 6 of the guidelines, imported product basis); the annual retention Form 4 must state the measures taken since registration, including changes.

2. Legal basis

3. Expert insights

Insight 1: The internal logic of the four categories is risk crossed with depth of regulatory involvement. Technical changes are confined to Class C/D, because only changes to the design, materials or manufacturing processes of medium- and higher-risk devices require re-review. Review changes cover Classes A/B and expressly list four situations: change of indications, addition of new models (except Class A accessories), deletion or revision of warnings, precautions or contraindications, and modification of the method of use (including moving from professional use to home use). Administrative changes handle matters of parties and documents. Notification changes are the lowest-risk tier. The key to reading this scheme: Kenya does not classify by the size of the alteration but by whether the alteration touches an already-reviewed technical conclusion. The same alteration falls into different categories at different risk classes, so classification experience from other jurisdictions cannot be transplanted directly.

Insight 2: Notification changes take effect on the confirmation email, but the proviso is the real constraint. The convenience of the notification category is that implementation may begin upon receipt of the confirmation email from the online system, with no approval wait. But the guidelines attach one critical proviso: unless the change stems from a reportable adverse event or an FSCA. The practical meaning: if a modification is itself made to correct a reported adverse event or to execute an FSCA, it cannot travel the notification channel and must return to the prior-approval track. Companies misjudge this in recall scenarios — executing corrective modifications as low-risk changes — and thereby commit a procedural change violation.

Insight 3: Of the five red lines, the first two trigger chain reactions. Change of intended use and change of risk classification are chained: once the intended use changes, the classification rules may apply anew and the class may rise, and a higher class changes the route, the depth of the dossier and the fees all at once — the registration fee is USD 1,000 for both Class C and Class D, USD 200 for Class B and USD 100 for Class A. These two changes therefore cannot be patched by change notification; only a fresh CSDT will do. The other three are equally rigid: change of device grouping; change of the medicinal substance in a drug-device combination (which touches the determination of the principal mode of action, and devices containing a registrable drug are always Class D); and adding devices under different proprietary names to the same family listing (even where the family grouping conditions are met).

Insight 4: The price of misclassification is a supply prohibition, not supplementary documents. The guidelines state the disposal for misclassification plainly: the change application is refused, and the company is prohibited from continuing to supply. This is far more severe than a deficiency letter, because it cuts off business in transit. Combined with the retention, suspension and revocation situations under Rule 11 — including false documentation, breach of certificate conditions, and changes to formulation, composition, design specification, quality, safety or presentation rendering continued registration inappropriate — the company is in effect backing its classification judgement with supply continuity. GRZAN recommends making change classification a mandatory review step, with the written determination issued by the regulatory function rather than the marketing function.

4. Practical recommendations

1. Institute a change classification review step. GRZAN recommends that every alteration first receive a written classification determination from the regulatory function before entering execution.
2. Check the five red lines first, then the four categories. Fix the determination order: does the change fall in one of the five fresh-submission situations; if not, which category does it belong to?
3. Route recall- and FSCA-related modifications through prior approval without exception. Any modification stemming from a reportable adverse event or an FSCA must not use the notification channel.
4. Reconcile the change ledger at annual retention. Form 4 must state the measures taken since registration (including changes); the ledger should match the submission records.
5. Budget the change at USD 200. Budget the fee for changes to imported registered devices on the Table 6 basis and check the actual PRIMS billing.
6. Bind downstream parties contractually. Agree with the LAR and distributors that no new product version or label may be released without PPB confirmation.

5. Verification checklist

• □ Is a written classification determination on record for the change?
• □ Has the change been compared item by item against the five red-line situations requiring a fresh CSDT?
• □ If classified as a notification change, has it been confirmed that the change does not stem from a reportable adverse event or an FSCA?
• □ Has the class applicability been judged correctly for technical changes (Class C/D) and review changes (Class A/B)?
• □ Has the administrative change completed the prior-approval procedure?
• □ Is the change fee of USD 200 budgeted and checked against the actual PRIMS billing?
• □ Does the annual retention Form 4 fully reflect the changes made in the period under the measures taken since registration?
• □ Is a clause agreed with the LAR and distributors that no new version may be released without PPB confirmation?

Regulatory information verified as of 30 October 2026.

In African markets, the GRZAN regulatory team focuses on jurisdictions such as Kenya, Nigeria, South Africa and Egypt and maintains a verification mechanism built on primary regulatory sources. Every regulatory conclusion it issues rests solely on official gazettes, the original text of competent authority guidelines and public legal databases, with the verification date stated; any figure, timeline or amount that cannot be located in an official source is marked as a practical estimate and is never presented as presumption.

GRZAN services cover market access strategy and risk classification; preparation and review of registration dossiers in CSDT, STED and CTD formats; selection and management of local authorized representatives (LARs); quality management system and GMP/GSDP compliance support; post-market vigilance, change management and recall response; import clearance and PVoC coordination; regulatory intelligence subscriptions and corporate compliance ledgers.

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