Kenya Medical Device Regulatory Landscape: PPB, LN 100 of 2022 and Fees

Content verification date: October 30, 2026

1. Key takeaways

• Kenya’s device registration authority is the Pharmacy and Poisons Board (PPB), whose powers derive from the Pharmacy and Poisons Act (Cap. 244). The current rules, Legal Notice No. 100 of 2022, contain a zero-tolerance gate in Section 3: no person may import, manufacture or sell in Kenya any unregistered health product or technology.
• Kenya applies a four-tier risk classification (Class A, B, C, D) aligned with GHTF/IMDRF; Class A requires listing only, while Classes B, C and D require full evaluation. Fees are in US dollars: Class A USD 100, Class B USD 200, and Class C and Class D USD 1,000 each.
• The legal hierarchy gives statutes priority: the PPB guideline (HPT/PER/HTR/GUD/011, Rev.02) states in Section 1.1 that where the guideline conflicts with any written law, the written law prevails.
• PPB applies five evaluation criteria: safety, effectiveness, quality and performance, plus economic value (Section 5(1) of LN 100 of 2022) — a review dimension rare in the region, so pricing and value-for-money materials should be prepared in advance.
• Device market access is not a single PPB track: imports must also pass the Kenya Bureau of Standards (KEBS) Pre-Export Verification of Conformity (PVoC) and the Single Window import licence; devices containing radiation sources additionally require authorization from the Kenya Nuclear Regulatory Authority (KNRA).

2. Legal basis

3. Expert insights

Insight 1: Section 3 is a zero-tolerance gate, not a procedural reminder

Section 3 of LN 100 of 2022 is a prohibition: unless registered under the Rules, no person may import, manufacture or sell health products or technologies in Kenya. Three points matter. First, the prohibition covers import, manufacture and sale, so all three need registration support. Second, a health product under Section 2 expressly includes medical devices and diagnostics, so the view that devices need no registration does not hold in Kenya. Third, Section 17 repealed the 1981 Drugs Registration Rules, leaving no legacy stock.

Insight 2: A two-certificate structure — beyond registration, a Cap. 244 licence is required

Section 5(4) provides that PPB issues a registration certificate only if the applicant holds one of five valid licences under the Pharmacy and Poisons Act: the practice licence under Section 9A, the wholesaler licence under Section 27, the mining or agricultural poisons licence under Section 28, the Part II poisons sale licence under Section 32, and the manufacturing licence under Section 35A. For foreign manufacturers this pushes the duty forward to the Local Authorized Representative (LAR) — the LAR must itself hold a qualifying licence, or the product gets no certificate even after passing technical review.

Insight 3: Economic value is the fifth evaluation criterion, not a formality

Section 5(1) requires PPB to be satisfied on safety, effectiveness, quality, performance and economic value before registration. Section 5(2) further empowers PPB to approve or revise the sales name, labelling and promotional claims (including claims, route of administration, dosage, storage conditions, contraindications, side effects and precautions, pack sizes). GRZAN’s assessment: Kenya has written value for money into market access, so pricing position, comparisons with registered comparable products and health-economics materials should be prepared alongside clinical data.

Insight 4: Three external tracks run in parallel with PPB

Track one is standards and customs: under the Standards Act (Cap. 496), KEBS operates PVoC pre-export verification, and importers must first obtain a Certificate of Conformity (CoC). The second is the Single Window: after the CoC, batch PPB import licences are applied for via KenTrade, under Cap. 485D. The third is radiation: devices containing radiation sources require KNRA authorization under the Nuclear Regulatory Act, No. 29 of 2019, in addition to PPB registration. Guideline Section 1.1 also notes that registered devices remain subject to other applicable legislation.

4. Practical recommendations

1. Classify first, then prepare the dossier. Make the question of whether a product is a medical device under Kenyan law the first project step, with a written determination record; for unclear boundaries (drug-device combinations, software, disinfection products, personal hygiene items), seek written clarification from the PPB medical devices unit early.
2. Write the legal hierarchy into the internal compliance manual. Check the statutes first (Cap. 244 and LN 100 of 2022), then the PPB guideline; where they diverge, always follow the law and keep a written rationale.
3. Prepare economic value materials in parallel. Prepare a short value argument page: target disease burden, existing alternatives, proposed pricing and supply stability, filed with the CSDT.
4. Bring LAR due diligence forward. Before signing the authorization letter, verify that the local representative holds a qualifying Cap. 244 licence, is not already occupied by other product lines, and can handle vigilance and complaints.
5. Build a timeline for all three tracks. Schedule PPB registration, PVoC, the Single Window import licence and KNRA authorization (if applicable) in parallel, so the certificate does not stall at customs.
6. Track institutional change. The proposed KHPTA will take over PPB functions, and transitional provisions will decide how pending applications and existing certificates carry over; keep application numbers and acknowledgement receipts on record for each pending case (the Bill had not completed the legislative process as of the verification date — a practical estimate).

5. Verification checklist

• □ Has a written conclusion been obtained on whether the product is a device (including IVD) or a borderline product in Kenya?
• □ Has the risk class (A/B/C/D) been confirmed, with classification reasons mapped to the rules?
• □ Has it been confirmed that a foreign manufacturer must appoint a local authorized representative holding a qualifying Cap. 244 licence?
• □ Has the submission route (listing / full evaluation / abridged / fast-track / immediate) and dossier depth been confirmed?
• □ Have registration and retention fees been budgeted in US dollars (three tiers: USD 100 / 200 / 1,000)?
• □ Has a parallel timeline been set for PVoC, the Single Window import licence and KNRA authorization (if applicable)?
• □ Have economic value materials been prepared?
• □ Has a ledger of pending application numbers been kept, ready for verification when the regulator changes?

Regulatory information verified as of October 30, 2026.

GRZAN focuses on Kenya, Nigeria, South Africa, Egypt and other African jurisdictions. All external conclusions rely on official gazettes, agency guideline texts and public legal databases, with the verification date stated; unlocatable figures and amounts are marked as practical estimates.

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.