Kenya Registration Exemptions, Clinical Research Imports and Compassionate Use

Content verified as of October 30, 2026

1. Key takeaways

• Guideline Section 2.14 lists five situations exempt from registration: marketing demonstration, education, clinical research or performance evaluation, custom-made devices, and special exemption.
• The exempted type list contains 8 items; those directly relevant to clinical research include devices imported for clinical research, serious adverse device events (SADE), investigational device exemption (IDE) progress reports, and clinical trial variations.
• An exempted party is also exempt from establishment licensing, but must first submit a notification with supporting documents to PPB; upon receipt PPB issues a payment notice under import and export control requirements.
• Authorization to import or distribute unregistered health products is applied for under Section 16 on Form 8; Section 16(7) requires progress reports every 6 months, immediate reporting of adverse events, and a progress report within 30 days of completion or termination of use.
• Section 16(12): donated health products and technologies are subject to the same section; the application fee for donated health products is USD 0.
• Compassionate use is applied for under Section 15 on Form 7; clinical trial involvement requires a recommendation from the National Clinical Trials Expert Committee, and supply must continue for at least 1 year after certificate expiry.

2. Legal basis

3. Expert insights

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

Section 2.14 carries a turn that is easy to miss: the exempted party is also exempt from establishment licensing, but must first submit a notification with supporting documents to PPB, and PPB issues a payment notice under import and export control requirements upon receipt. What the system exempts is the precondition of holding a registration certificate before importing; it does not exempt the act of keeping PPB informed. The most common corporate error is treating the exemption as an internal approval and shipping directly, so the goods arrive at port with neither a registration certificate nor a notification receipt and are held at the import and export stage. GRZAN’s assessment: the first work step of an exempt project is the notification receipt, not the freight booking.

Insight 2: Exemption and authorization run on two different tracks

The import of investigational devices goes through the Section 2.14 exemption notification, and the exempted types covering devices imported for clinical research, IDE progress reports and clinical trial variations all sit on this track. When an unregistered product is needed for actual clinical supply rather than research, the route is the Section 16 import and distribution authorization on Form 8, whose reporting duties are heavier: a progress report every 6 months, immediate reporting of adverse events, and a report within 30 days of completion or termination of use. The distinguishing criterion is purpose: generating data puts a product on the research track; diagnosis and treatment put it on the authorization track. Filing an authorization-track project as a research-track exemption misses both the 6-month and the 30-day reporting duties.

Insight 3: SADE is listed separately, showing that event reporting is an independent action

The exempted type list gives the serious adverse device event (SADE) its own entry alongside progress reports and clinical trial variations. That separate placement sends a message: a SADE report is not an annex to the progress report but an event that triggers its own procedure. Section 16(7) requires adverse events to be reported as they occur, so safety signals from investigational devices are not bound by the 6-month rhythm. GRZAN recommends standing up the event reporting channel and naming the responsible person at project initiation, not waiting for the first interim report.

Insight 4: Donation and compassionate use each carry their own bar

The application fee for donated health products is USD 0, but Section 16(12) makes clear that donated health products and technologies fall under Section 16, so a zero fee is not zero obligation and the 6-month and 30-day reports apply as usual. Compassionate use runs on the Section 15 Form 7 with a higher bar: the applicant must show approval in a country with equivalent requirements, major innovation, use for chronic or seriously debilitating diseases that no registered product can treat satisfactorily; Section 15(5) further requires free supply during the certificate and continued supply for at least 1 year after expiry. Where clinical trials are involved, a recommendation from the National Clinical Trials Expert Committee must also be attached.

4. Practical recommendations

1. Secure the notification receipt before arranging logistics. Complete the PPB notification and supporting documents before shipment and retain the receipt and payment notice.
2. Separate the research track from the authorization track. Data-generating purposes take the Section 2.14 exemption; diagnostic or treatment supply takes the Section 16 Form 8 authorization.
3. Build a reporting calendar. Set dual reminders for the 6-month progress report and the 30-day post-completion or post-termination report on Section 16 projects.
4. Stand up the SADE channel first. Name the event reporting owner at project start and keep event reports out of progress reports.
5. Perform donation obligations as usual. A zero application fee does not waive reporting; the 6-month and 30-day requirements still apply.
6. Assemble compassionate use evidence early. Prepare the approval proof from equivalent-requirement countries, the innovation and unmet-need arguments, and the at least 1 year post-expiry supply commitment together.

5. Verification checklist

• □ Has it been confirmed which of the five exempt situations the planned activity falls under?
• □ Has the notification with supporting documents been submitted to PPB in advance and a receipt obtained?
• □ Has it been confirmed whether the research track (Section 2.14 exemption) or the authorization track (Section 16, Form 8) applies?
• □ Are reminders in place for the 6-month progress report and the 30-day post-completion or post-termination report?
• □ Is the SADE reporting channel and owner in place, kept separate from progress reports?
• □ For donations, has the Section 16 reporting obligation been confirmed (application fee USD 0)?
• □ For compassionate use, are the Form 7 materials, expert committee recommendation and at least 1 year supply commitment ready?
• □ Are the import, use, export or disposal records of investigational devices complete and traceable?

Regulatory information verified as of October 30, 2026.

Across African markets, the GRZAN regulatory team focuses on jurisdictions including Kenya, Nigeria, South Africa and Egypt, and operates a verification mechanism built on primary regulatory sources: every regulatory conclusion published externally rests solely on official gazettes, the original text of competent authority guidelines and public legal databases, each marked with its verification date. Any figure, timeline or amount that cannot be located in an official source is labeled as a practical estimate and never presented as an assumption.

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

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