Kenya Pharmacy and Poisons Act Cap. 244: Legal Basis for Device Regulation

Content verification date: October 30, 2026

1. Key takeaways

• Every subordinate rule governing medical device regulation in Kenya traces back to two authorizations in the Pharmacy and Poisons Act (Cap. 244): Section 3A and Section 3B. Section 3A(a) empowers PPB to make guidelines on the manufacture, import, export, distribution, sale and use of medical devices and In-Vitro Diagnostics (IVD); Section 3A empowers PPB to grant or withdraw marketing authorizations for devices and IVDs and to attach and revise conditions.
• Section 3B(2)(b) requires PPB to ensure that all pharmaceutical products manufactured, imported or exported in the country meet prescribed standards of quality, safety and effectiveness; Section 3B(2)(i) requires PPB to consider application dossiers for marketing authorization and their variations; Section 3B(2)(r) empowers PPB to cooperate with other national, regional and international bodies, and on that basis to recognize and rely on registrations and certifications from notified bodies and reference regulators.
• Section 44(1)(d) is the birth certificate of the Rules — it empowers the Cabinet Secretary for Health, after consultation with PPB, to make registration rules, and LN 100 of 2022 was made under exactly this provision.
• Section 3B(2)(r) contains a key self-limitation: even where PPB relies on the decisions, assessments and information of others, it remains independent and is responsible for its own decisions.
• On the licence side there are five hard gates: Sections 9A, 27, 28, 32 and 35A.

2. Legal basis

3. Expert insights

Insight 1: Kenya’s device regulatory power is derived, not written in a standalone statute

Unlike the EU MDR or the US FD&C Act, Kenya has no dedicated statute called a Medical Devices Act. PPB’s power over devices is derived from Cap. 244 — an older law aimed at drugs and poisons — through the the broad wording of Sections 3A and 3B (medical products, health technologies). GRZAN notes two immediate consequences. First, device rules rank as subsidiary legislation, which is issued and revised more frequently than dedicated statutes, so companies must track them dynamically. Second, if a competence dispute arises, the argument returns to the boundaries of the wording of Cap. 244, not to any device-specific act.

Insight 2: Section 3B(2)(r) is the mother clause of the reliance pathways

The whole PPB design of Abridged, EBR, IBR, ECR and EDR routes — trading foreign approvals for reduced review intensity — rests legally on Section 3B(2)(r): PPB may cooperate with national, regional and international bodies and recognize and rely on registrations and certifications from notified bodies and listed reference regulators. The same section states that PPB remains independent, responsible and accountable, which Section 1.2 of the guideline repeats verbatim. GRZAN’s reading: Kenyan reliance is discretionary reliance, not automatic recognition — even a dossier carrying approvals from all 8 reference regulators leaves PPB free to request supplementary data or attach registration conditions. Treating reliance routes as inspection-free lanes is a common misjudgement.

Insight 3: Section 44(1)(d) determines how the Rules change, and therefore what companies should monitor

The preamble of LN 100 of 2022 states IN EXERCISE of the powers conferred by section 44(1)(d), and records that the Cabinet Secretary made the Rules after consultation with PPB. This means amendments to the registration rules follow the subsidiary legislation gazettement procedure rather than a parliamentary process — faster, with shorter advance notice. GRZAN recommends moving monitoring from parliamentary business down to Legal Notices in the Kenya Gazette and PPB guideline revisions, because the changes that actually alter submission practice usually appear in the latter.

Insight 4: Five licences form a hidden access condition on the holder side

Section 5(4) makes the five Cap. 244 licences (Sections 9A, 27, 28, 32 and 35A) a precondition for issuing the registration certificate. For foreign manufacturers this is an easily missed gate: however complete the technical dossier, no certificate can issue if the local authorized representative lacks the matching wholesaler or manufacturing licence. In due diligence, GRZAN routinely lists the match between the LAR’s licence type and the intended activities as the first checkpoint.

4. Practical recommendations

1. Validate every submission requirement against the authorization chain. When PPB requests materials, first ask whether the legal basis sits under Section 3A, 3B or the rules made under Section 44(1)(d); for oral requests without a basis, ask for written explanation.
2. Treat reliance as a discretion, not an entitlement. In reliance-route dossiers, keep the ability to retrieve the original technical files quickly, beyond the reference-regulator approvals, to answer PPB supplementary requests.
3. Run two-layer monitoring. Monitor Legal Notices in the Kenya Gazette (affecting rules under Cap. 244) at the upper layer, and PPB guideline revisions (affecting CSDT format, route conditions and fee positions) at the lower layer.
4. Match LAR licences in due diligence. Verify that the licence types held by the local representative (practice / wholesale / manufacturing) align with the role it plays in the submission.
5. Watch the succession of the single regulatory authority legislation. The single regulatory authority designed in Section 62 of the Health Act, No. 21 of 2017, connects with the proposed KHPTA; the device authorization provisions of Cap. 244 may in future be migrated wholesale, and the legal citation of existing documents would need updating in step.

5. Verification checklist

• □ Has it been confirmed that the applicable rules were made under Section 44(1)(d)?
• □ Have the authorization provisions cited in Section 1.2 of the PPB guideline been checked against the current text of Cap. 244?
• □ For reliance-route dossiers, is a plan in place to retrieve original technical files beyond the reference-regulator approvals?
• □ Does the LAR’s Cap. 244 licence type match the intended activities?
• □ Does the monitoring list include both Kenya Gazette Legal Notices and PPB guideline revisions?
• □ Has PPB’s power under Section 3A to attach and revise conditions been included in post-market change management planning?
• □ Has the discretionary nature of Section 3B(2)(r) — reliance with independence — 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.

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.