Kenya Registration Exemptions: Five Categories and Notice Duties

Content verified on: October 30, 2026

1. Key takeaways

• Section 2.14 of the Guidelines sets five categories of registration exemption: for marketing demonstration, for education, for clinical research or performance evaluation, custom-made devices, and special exemption.
• The exemption-type list is further broken down into eight specific situations, covering demonstration devices; destruction, disposal or export of unregistered devices; devices for education; imported devices for clinical research; serious adverse device events; export or disposal of devices after a study is completed or terminated; progress reports on study devices; and clinical trial changes.
• Those exempted are also exempt from establishment licensing, but the prior-notification duty is not exempted — a notification with supporting documents must be submitted to PPB in advance.
• After receiving the notification, PPB issues a payment notice under import and export control requirements; exemption does not mean zero cost.
• Exemption removes the registration duty, not the reporting duty: Serious Adverse Device Event (SADE) reporting, Investigational Device Exemption (IDE) progress reports and clinical trial change notifications still apply.

2. Legal basis

3. Expert insights

Insight 1: What is exempted is the registration duty, not the regulatory duty

Regulation 3 sets the access threshold in prohibitive terms, and the exemptions in section 2.14 are openings carved into that threshold. GRZAN notes that exemption is bounded in three ways: by purpose (demonstration, education, research, custom-made or special exemption), by procedure (prior notification with supporting documents), and by consequence (SADE reporting, progress reports and change notifications are not waived). Reading an exemption as meaning that this consignment needs no attention at all is the most common misjudgement in practice, and it is exactly the reading that regulators punish first.

Insight 2: Prior notification is the effectiveness precondition of an exemption; a late notice has no retroactive effect

The Guidelines expressly require the notification and supporting documents to be submitted to PPB in advance. GRZAN judges that this timing requirement is substantive, because after receiving the notification PPB issues a payment notice under import and export control requirements, forming an administrative chain from notification to payment. If the goods arrive at port first and the notification is filed afterwards, the consignment sits in an unlicensed state throughout the import process and falls squarely within the reach of the prohibition in regulation 3.

Insight 3: The boundary between custom-made devices and special exemption is the easiest to misuse

The exemption logic for custom-made devices rests on a specific patient, a specific need and non-series supply, while special exemption is a discretionary channel. GRZAN recommends retaining, case by case, the medical prescription or prescription basis, the adaptation records and the quantity statement for custom-made devices, so that the custom-made character can be verified after the fact; for special exemption, the notification should state the grounds for the request, an explanation that no registered alternative is available, and the scope of use, so that exemption is never used as a cover for routine supply.

Insight 4: Destruction, disposal and export also run through the exemption-type list

The exemption-type list includes destruction, disposal or export of unregistered devices as well as export or disposal of devices after a clinical or pharmaceutical study is completed or terminated. GRZAN notes that leaving the market is itself a regulated action requiring corresponding notification and evidence. If the destination of study devices after a study ends is not handled through the proper procedure, it creates a books-versus-reality mismatch that resurfaces in later registrations and inspections.

4. Practical recommendations

1. Determine the exemption type first. GRZAN recommends confirming, before shipment, which of the five categories and eight types applies, and recording the reasoning in writing.
2. Submit the notification in advance. Submit the notification and supporting documents to PPB before shipment as the Guidelines require, and keep the submission receipt before arranging transport.
3. Evidence the custom-made character case by case. Retain the prescription basis, adaptation records and quantity statement for every custom-made device.
4. State the scope and period of use. Set out the purpose, institutions, quantities and expected period of use in the notification to prevent out-of-scope use.
5. Keep reporting unbroken. Build triggers for SADE and progress reports and submit on schedule both during and after the study.
6. Process exit formalities. For devices destroyed, disposed of or exported, follow the exemption-type list, notify accordingly and retain disposal evidence.

5. Verification checklist

• □ Has it been confirmed that the devices to be imported fall within one of the five exemption categories?
• □ Has the specific situation been matched against the eight exemption types?
• □ Was the notification with supporting documents submitted to PPB in advance, before shipment?
• □ Have the notification submission receipt and the PPB payment notice been retained?
• □ Have the prescription basis, adaptation records and quantity statement been retained for each custom-made device?
• □ Does the notification state the purpose of use, institutions, quantities and period of use?
• □ Are triggers for SADE reports and IDE progress reports in place?
• □ Have devices destroyed, disposed of or exported been processed with evidence retained?

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.

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