Kenya Medical Device Registration: Form 1, Form 2 and Five-Year Certificates

Content verified on: October 30, 2026

1. Key takeaways

• Applications for medical device registration in Kenya are made on Form 1; once approved, the Pharmacy and Poisons Board (PPB) issues the registration certificate on Form 2. Both the registration certificate and the renewal certificate are valid for 5 years from the date of issue (regulation 10(1) of LN 100 of 2022).
• Issuance is gated by an entity-qualification precondition: under regulation 5(4), before a certificate is issued the applicant must hold one of five valid licences under the Pharmacy and Poisons Act (Cap. 244), namely sections 9A, 27, 28, 32 or 35A.
• The assessment rests on five determinations — safety, effectiveness, quality, performance and economic value (regulation 5(1)). If any one of them is missing, PPB will not register the product.
• Certificates carry a continuation-while-pending protection: where a renewal application is made before expiry, the certificate remains valid until PPB makes its decision (regulation 10(2)).
• Refusal is not a unilateral act: regulation 5(5) requires PPB to first give the applicant an opportunity to be heard and to state its reasons in writing. The register is kept by the Registrar on Form 3 (regulation 6).

2. Legal basis

3. Expert insights

Insight 1: Form 1 and Form 2 are the entry and the exit, and the licence holder must be the same entity as the applicant

The Rules build a closed loop of application, approval, maintenance, variation and exit around eight forms: Form 1 carries the application intent, Form 2 carries the approved outcome. GRZAN notes that what trips applicants up more often than form content is entity identity. If the applicant on Form 1 is an offshore Legal Manufacturer (LM) while the actual licence holder, customs clearance and vigilance duties sit with a Local Authorized Representative (LAR), the licence-holding entity, the LAR appointment and the person responsible for labelling must all be aligned once, at the application stage. Any later inconsistency has to be repaired through the variation notification procedure, costing time and exposing the file to queries during review.

Insight 2: Regulation 5(4) places who may hold the licence before whether the product is any good

The five classes of licence listed in regulation 5(4) all concern entity qualifications and have nothing to do with product performance. This means passing technical review is a necessary but not a sufficient condition for registration. For offshore manufacturers, the provision pushes the compliance burden forward onto the LAR: the LAR must itself hold a qualifying licence under Cap. 244 and must hold a licence to carry on the business of medical devices (including in-vitro diagnostics) in Kenya. GRZAN recommends completing this verification before the authorisation letter is signed, not at the tail end of the review when correction is costly.

Insight 3: Continuation under regulation 10(2) is conditional protection, not an automatic extension

The effect of regulation 10(2) depends on a single action — filing the renewal application before expiry. A late application falls outside the protection: the certificate lapses on its expiry date and the product immediately comes within the reach of the prohibition in regulation 3. GRZAN recommends fixing the renewal start date at 12 months before expiry, leaving a working window for assembling vigilance and product safety reports and the quality review.

Insight 4: The procedural rights in regulation 5(5) should be used actively

Regulation 5(5) requires PPB to give the applicant a chance to be heard before refusal and to state its reasons in writing. The value of that procedural right lies in creating a written record: once a matter later involves seizure, suspension or cancellation under regulation 11, or file succession when the regulator changes, this document setting out the reasons becomes the key evidence for judging the nature of the case and defending the product history.

4. Practical recommendations

1. Build a certificate ledger. GRZAN recommends recording, per certificate number, the issue date, expiry date, licence-holding entity, LAR, product family and risk class, with a reminder set 12 months before expiry.
2. Verify the prior licence. Obtain and keep a copy of the qualifying licence under Cap. 244 before submitting Form 1, and confirm that the name on the licence matches the applicant name exactly.
3. Prepare the economic-value material in advance. Assemble a pricing and health-economics explanation page as required by regulation 5(1) and file it alongside the Common Submission Dossier Template (CSDT).
4. Keep labelling aligned with the licence holder. The responsible-person details on the intended label must match Form 1, the Declaration of Conformity and the LAR authorisation letter.
5. Record review correspondence in writing. Archive every PPB request for additional information, every response and any refusal reasons one by one to form a traceable file.
6. Track the legislative process. The proposed Kenya Health Products and Technologies Regulatory Authority (KHPTA) would take over PPB functions, and how existing certificates carry over depends on transitional provisions; GRZAN recommends keeping the issuance evidence for each certificate for cross-checking (this bill had not completed the full legislative process as of the verification date; this is a practical estimate).

5. Verification checklist

• □ Has it been confirmed that the application is made on Form 1 and the certificate is issued on Form 2 after approval?
• □ Has the certificate issue date been retained, with the expiry date calculated on the 5-year validity?
• □ Does the licence holder hold one of the valid licences under sections 9A, 27, 28, 32 or 35A of Cap. 244?
• □ Has the offshore manufacturer appointed a single LAR, and does that LAR hold a licence to operate a device business in Kenya?
• □ Does the applicant name match the label, the Declaration of Conformity and the LAR authorisation letter exactly?
• □ Has economic-value explanatory material been prepared for the regulation 5(1) assessment?
• □ Is there a reminder mechanism to start renewal 12 months before expiry?
• □ Are the certificate issuance evidence and review correspondence archived for cross-checking if the regulator changes?

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.