Kenya Drug-Device Combination Products: PMOA Determination and Class D

Content verification date: October 30, 2026

1. Key takeaways

• Kenya’s standard for determining the track of a drug-device combination product is the Primary Mode of Action (PMOA): the mode of action that provides the greatest contribution to the overall intended therapeutic effect of the combination product.
• The determination rule: any product whose PMOA is not achieved by pharmacological, immunological or metabolic means in or on the human body is regulated as a medical device under the Pharmacy and Poisons Act.
• Typical examples regulated as devices include drug-eluting stents, dermal fillers containing a local anaesthetic, and silver-containing antimicrobial dressings.
• One rigid conclusion: a medical device incorporating a registrable medicinal substance is always classified as Class D, with no downgrading based on the quantity of drug it contains.
• Devices incorporating registrable drugs are reviewed jointly by the medical devices department together with the biologics department and the human drugs department. The abridged review route is available only where the device has been approved as a device by at least 1 PPB reference regulator and the medicinal or biological component has been evaluated and approved by at least 1 competent drug regulatory authority as defined by WHO.

2. Legal basis

3. Expert insights

Insight 1: PMOA is a greatest-contribution test, not a contains-drug test

Section 2.6 of the guideline defines PMOA by reference to the mode of action that makes the greatest contribution to the overall intended therapeutic effect of the combination product. GRZAN’s note: the common misjudgement is to assume that any product containing a drug belongs to the drug track. Under the Kenyan rule, the dominant action of a silver-containing antimicrobial dressing is physical coverage and barrier function, with the silver ions providing ancillary antimicrobial action, so it is regulated as a device. Only where the drug action contributes more than the device action to the therapeutic purpose does the product move onto the drug track. The determination evidence should rest on the consistency of three items: the mechanism of action description, the clinical evidence, and the label claims.

Insight 2: Registrable drug on board means Class D — a flat rule, not dose-graded

Section 2.6 of the guideline states that medical devices incorporating a registrable medicinal substance are classified as Class D. The provision leaves no gradient for content, release rate, or local versus systemic action. GRZAN’s reading: this is a conservative alignment adopted under regulatory capacity constraints — high-risk combination products are uniformly pushed to the highest review intensity, with drug-department joint review added. The impact on companies is direct: a drug-eluting stent that is Class III in the EU or approved via PMA in the US must still be prepared at Class D in Kenya, with no compression of the dossier to an intermediate risk tier.

Insight 3: Joint review creates cross-department timing gaps; the dossier must fit both directions

Applications for drug-containing devices are assessed by the medical devices department together with the biologics department and the human drugs department. GRZAN’s note: the three departments focus on different things — the device side looks at performance and risk, while the drug side looks at the quality, safety and effectiveness of the active ingredient. The dossier must satisfy two evidence logics simultaneously, and supplementary requests from either side slow the whole process. In practice, GRZAN recommends attaching a cross-department index page to the CSDT, showing which document answers which type of question for which department.

Insight 4: The abridged route threshold is split into a device leg and a drug leg

To use abridged review, a drug-containing device must satisfy both conditions: first, the product has been approved as a medical device by at least 1 PPB reference regulator; second, its chemical or biological component has been evaluated and approved by at least 1 competent drug regulatory authority as defined by WHO. Failing either condition leaves only the full evaluation route. GRZAN’s judgment: this 1+1 design favours companies — it does not require the same authority to have reviewed both the device and the drug, so evidence can come from different regulators; but neither leg can be missing, and both require an approved status, not a pending one.

4. Practical recommendations

1. Determine PMOA early and in writing. Issue a PMOA determination at project initiation, with the mechanism-of-action description and an evidence list, so the track is not challenged mid-submission.
2. Resample resources at Class D. Budget timelines and dossier depth for drug-containing products at Class D by default, with no downgrade assumptions.
3. Add a cross-department index page to the dossier. Map each document to the reviewing department and question type, reducing back-and-forth.
4. Prepare device-side and drug-side approval evidence separately. The two legs of the abridged route may come from different authorities, but both must be in approved status.
5. Keep label claims consistent with the PMOA. Claims that emphasize pharmacological action can undermine the determination that the product is regulated as a device.
6. Ask in writing when the boundary is unclear. The guideline expressly allows applicants to consult PPB on the classification of such products to confirm the applicable regulatory controls.

5. Verification checklist

• □ Has a PMOA determination been issued with an evidence list?
• □ Has it been confirmed whether the product incorporates a registrable drug (if so, always Class D)?
• □ Have timelines and dossier budgets been configured at Class D?
• □ Does the dossier include the cross-department index page?
• □ Have device-side and drug-side approval evidence both been obtained, each in approved status?
• □ Are label claims consistent with the PMOA determination?
• □ For medicinal substances exempt from drug registration, has it been confirmed that classification switches to the device rules?
• □ Has the track determination been submitted to PPB in writing where applicable, with replies retained?

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.

GRZAN services cover: market access strategy and risk classification; preparation and review of registration dossiers (CSDT / STED / 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 clearance and PVoC coordination; regulatory intelligence subscriptions and corporate compliance ledgers.

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