Kenya Medical Device Establishment Registration: Licences and Evidence

Content verified on: October 30, 2026

1. Key takeaways

• Kenya licenses the entity and the product separately: no company or individual may manufacture, import, export or distribute medical devices without holding a certificate of registration as a medical device establishment.
• Import for personal use is the only exception: no establishment registration is required, but PPB import authorisation must still be obtained.
• The application dossier contains 10 items: the application form, a copy of the quality manual, evidence of an established quality management system, a written declaration by the Official Correspondent and the authorised representative, electronic copies of the QMS manual and procedures, practising and registration certificates, the certificate of incorporation, a complete list of devices, and proof of payment.
• PPB applies a two-stage process of document review plus an on-site inspection; anything declared in documents must be verifiable on the ground.
• Expiry rules come in two classes: the establishment registration certificate expires on December 31 each year and is renewed annually, while the manufacturer certificate is valid for 5 years after a successful re-inspection.
• Evidence requirements scale with risk class: Class C or D requires proof of pre-market approval or registration by at least 1 IMDRF member authority, or WHO prequalification confirmation (called the original approval); Classes B, C and D require a Certificate of Free Sale (CFS) from the country of manufacture or final assembly; Class C/D holders must be able to provide the full technical documentation on request.

2. Legal basis

3. Expert insights

Insight 1: Entity qualification is the door one step before product registration

Regulation 5(4) requires the applicant to hold a qualifying licence under Cap. 244 before a registration certificate can be issued, and the establishment registration certificate is precisely the core evidence that the entity is capable of manufacturing, importing or distributing. GRZAN notes that the two procedures must be scheduled in parallel, not in series. Waiting for the product registration to be approved before starting establishment registration will directly block the issuance condition in regulation 5(4) and stall the entire file at the final gate.

Insight 2: The Official Correspondent is a responsibility post specific to Kenya

The dossier list specifically requires a declaration from the Official Correspondent that procedures for complaint handling, Field Safety Corrective Action (FSCA), handling and disposal of non-conforming and counterfeit products and similar matters are documented. GRZAN reads this post as the standing interface between PPB and the licensed entity, functionally distinct from the Local Authorized Representative (LAR) appointed by the offshore manufacturer: the LAR answers for the product and for the regulator, while the Official Correspondent focuses on the operability of the quality system and of incident response. The two roles may be held by the same entity, but the duty lists should be documented separately to avoid gaps at the boundary.

Insight 3: Documented declarations must withstand on-site verification

The word documented recurs throughout the checklist — declarations of procedures, electronic copies of the QMS manual and procedures, and declarations by the authorised representative or responsible persons covering handling, storage, delivery, installation, corrective actions and servicing procedures. PPB conducts an on-site inspection after document review, which means the verifiability of these documents is itself an object of review. GRZAN recommends preparing at three layers — declaration, procedure, record: each declaration points to a procedure, and each procedure points to record samples that can be sampled on the spot.

Insight 4: Matching evidence to risk class is the key to controlling the evidence-collection timeline

Classes C/D require proof of pre-market approval or registration by at least 1 IMDRF member authority, or WHO prequalification confirmation; Classes B/C/D require a CFS from the country of manufacture or final assembly; and Class C/D holders must be able to hand over the full technical documentation whenever PPB asks. GRZAN judges that among these three requirements, the original approval has the longest collection timeline, since it depends on an offshore licence holder issuing documents, and its source should therefore be locked in at project initiation, while access to technical documentation should be run as an internal SLA so that a late file retrieval never delays an inspection.

4. Practical recommendations

1. Schedule in parallel. GRZAN recommends starting establishment registration and product registration on the same timeline, securing entity qualification before entering the issuance stage.
2. Build the file around the 10-item list. Assemble one item at a time: application form, quality manual, QMS evidence, the two responsibility declarations, electronic copies, practising certificates, certificate of incorporation, device list and proof of payment.
3. Structure the device list. The list must carry product codes, product descriptions, brand names and family names; GRZAN recommends maintaining it from the same source as GMDN (Global Medical Device Nomenclature) codes and label data.
4. Rehearse the on-site inspection. Run the three-layer self-check of declaration, procedure and record, focusing on closed-loop records for complaints, FSCA and non-conforming product disposal.
5. Lock in the original approval early. For Classes C/D, identify the IMDRF member approval or WHO prequalification document and its issuing authority as early as possible.
6. Set a certificate calendar. Establishment certificates expire on December 31 each year and manufacturer certificates run 5 years after re-inspection; set separate reminders for the two expiry regimes.

5. Verification checklist

• □ Has the entity intending to manufacture, import, export or distribute obtained the establishment registration certificate?
• □ For personal-use imports, has PPB import authorisation been obtained separately?
• □ Are all 10 dossier items complete and filed?
• □ Is the Official Correspondent’s declaration on complaint handling, FSCA and non-conforming or counterfeit product disposal documented?
• □ Is the authorised representative’s declaration on handling, storage, delivery, installation, corrective actions and servicing documented?
• □ Has the three-layer rehearsal of declaration, procedure and record been completed for the on-site inspection?
• □ For Classes C/D, has approval by at least 1 IMDRF member authority or a WHO prequalification document been secured?
• □ For Classes B/C/D, has a Certificate of Free Sale from the country of manufacture or final assembly been obtained?

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.