IVD Jurisdiction in Kenya: PPB versus KMLTTB and Compliance Practice

Content verification date: October 30, 2026

1. Key takeaways

• Regulatory competence over laboratory equipment and reagents (including IVD) in Kenya was long disputed between the Pharmacy and Poisons Board (PPB) on one side and the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB, Cap. 253A) on the other.
• PPB’s gazette basis for exercising this competence is Gazette Notice No. 1879 (March 21, 2014) together with Legal Notice No. 192 of 2010; KMLTTB’s basis is Legal Notice No. 113 of 2011.
• The dispute went to the High Court: Miscellaneous Application E043 of 2021, [2025] KEHC 7574 (KLR), judgment delivered June 3, 2025.
• As far as corporate compliance actions are concerned, the current practical estimate is unchanged: laboratory equipment and reagents must complete PPB registration or listing, and before import a Certificate of Conformity (CoC) from KEBS must first be obtained, followed by a PPB import licence applied for through the KenTrade Single Window.
• GRZAN’s judgment: until the gazette basis is expressly revoked or the law is amended, following the PPB position is the only low-risk option.

2. Legal basis

3. Expert insights

Insight 1: The dispute itself shows that gazette authorizations are a common form of device regulation in Kenya

PPB’s competence over laboratory equipment and reagents flows not from any single explicit device statute, but from the combination of a 2010 Legal Notice and a 2014 Gazette Notice. GRZAN’s note: Kenyan device regulatory power takes the form of parent-statute authorization plus gazette elaboration, and both Gazette Notices and Legal Notices carry real binding force. When building a compliance argument, companies must include gazette-level documents in their regulatory library; watching parliamentary legislation alone will miss key competence instruments.

Insight 2: The litigation history shows the risk of parallel regulation is not fully eliminated

According to the judgment record, KMLTTB previously brought judicial review against LN 192 of 2010 and Gazette Notice No. 1879 (JR Misc. Application No. 229 of 2014), and withdrew it in August 2014; KMLTTB then issued a Memo on December 21, 2020 requiring it to verify medical devices, prompting the Association of Medical Laboratory Diagnostics Suppliers to bring the present judicial review. GRZAN’s reading: even though PPB’s gazette basis was not overturned in litigation, the operational risk of parallel regulation persists — a company’s equipment and reagents may simultaneously face PPB registration requirements and technical verification demands from another body.

Insight 3: The optimal strategy is to follow the PPB main line while keeping a compliance evidence chain

GRZAN’s practical conclusion: until the gazette basis is formally revoked, companies should treat PPB registration or listing as the main line of compliance and preserve three pieces of evidence: the PPB registration certificate or listing evidence, the CoC issued by KEBS, and the import licence obtained through the Single Window. When confronted with a parallel-regulation claim, this evidence chain demonstrates that the company has complied with the requirements of the national medicines regulator, which is the lowest-risk position.

Insight 4: The IVD definition was made standalone in the 2022 Rules, further consolidating the PPB position

Section 2 of LN 100 of 2022 gives an independent definition of an in-vitro diagnostics medical device: a medical device intended by the manufacturer for the in vitro examination of specimens derived from the human body, used alone or in combination, to provide information for diagnostic, monitoring or compatibility purposes solely or principally. GRZAN’s judgment: by writing IVDs into the master registration rules, the 2022 Rules consolidated PPB’s competent position over IVDs at the level of written law, materially narrowing the space for future competence disputes.

4. Practical recommendations

1. Complete registration or listing under the PPB line. Laboratory equipment and reagents should be registered or listed with PPB at the corresponding risk class, without substituting verification by another body.
2. Build a three-document evidence chain. PPB registration evidence plus the KEBS CoC plus the Single Window import licence — all three are required, batch-matched.
3. Bring gazette-level documents into the regulatory library. Alongside parliamentary legislation, collect device-related Gazette Notices and Legal Notices from the Kenya Gazette.
4. Track the follow-up of the case. Monitor any subsequent proceedings on the [2025] KEHC 7574 (KLR) judgment and whether new gazette notices are issued.
5. Never reverse the Single Window order. Obtain the CoC first, then apply for the PPB import licence, with a separate application for each batch.
6. Watch the Section 62 single regulatory authority legislation. If the design of Section 62 of the Health Act lands, the competence-boundary dispute will end with institutional consolidation.

5. Verification checklist

• □ Have laboratory equipment and reagents completed PPB registration or listing?
• □ Have Gazette Notice No. 1879 and LN 192 of 2010 been collected into the regulatory library?
• □ Is a batch-matched ledger in place for the three documents: PPB evidence, CoC and import licence?
• □ Are the follow-up proceedings of Misc. Application E043 of 2021 being tracked?
• □ Has the applicability of the Section 2 definition of IVD in LN 100 of 2022 been confirmed?
• □ Is the import process scheduled in the order CoC first, import licence second?
• □ Has the current status of the competence-boundary dispute and the response strategy been recorded in internal documents?

Regulatory information verified as of October 30, 2026.

In African markets, the GRZAN regulatory team focuses on jurisdictions including Kenya, Nigeria, South Africa and Egypt and maintains a verification mechanism built on primary regulatory sources: every regulatory conclusion published externally is based solely on official gazettes, the original text of agency guidelines and public legal databases, with the verification date stated; figures, timelines and amounts that cannot be located in official sources are marked as practical estimates, with no assumptions made.

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