WHO Maturity Level 3 and Reliance Pathways for Medical Devices in Kenya

Content verification date: October 30, 2026

1. Key takeaways

• PPB is pursuing WHO Maturity Level 3 (ML3) and preparing for a World Health Organization Global Benchmarking Tool (GBT) evaluation in September 2026.
• The legal basis of the reliance pathway is already written law: section 3B(2)(r) of the Pharmacy and Poisons Act (Cap. 244) authorises PPB to cooperate with other countries and regional and international institutions in regulating medicinal substances, and on that basis to recognise and rely on registrations and certifications of notified bodies and reference regulators, while PPB remains independently responsible for its own decisions.
• The reliance pathway has landed as 8 Reference Regulatory Agencies (RRA) and channels including Abridged, EBR, IBR, ECR and EDR; under Immediate Class B Registration (IBR) a product can be listed on the PPB online register within 1 hour.
• Enforcement is tightening in parallel: on October 30, 2025 PPB adopted a risk-based inspection framework anchored on WHO standards, applying equally to wholesalers, community pharmacies and hospital pharmacies, and is rolling out Good Storage and Distribution Practice (GSDP) across the board.
• Enforcement intensity shows measurable signals: public reporting states that intelligence-led operations have arrested more than 95 illegal operators, with measures against 22 wholesale establishments suspected of supplying illegal outlets. These figures come from public reporting and are treated by GRZAN as practical estimates.

2. Legal basis

3. Expert insights

Insight 1: the ML3 push raises evidentiary requirements rather than loosening channels

GRZAN’s judgement: companies easily read ML3 as PPB becoming more international and easier to pass, when the direction is exactly opposite. The GBT evaluation measures the regulator’s own maturity: standardisation of review procedures, traceability of decisions, and effectiveness of post-market control. To score highly in the GBT, PPB must display procedural rigour around the evaluation window. For companies this means higher demands on documentation completeness and consistency: data across CSDT modules must reconcile, cited studies must carry full reports, and risk management and clinical evaluation conclusions must support each other. Rough submissions once absorbed through relationships and deficiency responses will face clearly rising difficulty during the evaluation window.

Insight 2: independent responsibility under section 3B(2)(r) is the ceiling of the reliance pathway

Section 3B(2)(r) carries two meanings, of which the second is often missed. The first is authorisation: PPB may recognise and rely on registrations and certifications of other institutions, the legal foundation of every reliance route, Abridged, EBR, IBR, ECR and EDR. The second is reservation: PPB remains independently responsible for its own decisions. GRZAN concludes that reliance routes deliver a lighter review burden, not predictable outcomes. Even with approvals from 5 RRAs, PPB may attach conditions, request supplements or reach a different judgement. This explains why, although IBR lists a product within 1 hour, PPB reserves post-listing verification and additional conditions, and registrations not meeting IBR conditions are cancelled with fees non-refundable.

Insight 3: the independence test is the real technical threshold of the reliance pathway

The Guidelines name the 8 RRAs and qualify independent approval: EU and Australia’s TGA approvals count as independent only where granted by the agency’s own review, not where registration rested on a Mutual Recognition Agreement (MRA). The IBR provisions expressly list 7 independent reference agencies: HC, MHLW, USFDA, TGA, EU NB, SWISSMEDIC and HPRA. GRZAN notes this rule requires companies to prove the provenance of each approval, not merely submit the certificate. CE certificates based on MRA registration do not count as independent approvals in Kenya, so companies must check the approval pathway of every certificate when compiling RRA evidence; otherwise approvals are struck out late in review, leaving the product short of pathway eligibility and forcing a route change.

Insight 4: the risk-based inspection framework carries regulatory pressure into distribution

On October 30, 2025 PPB adopted a risk-based inspection framework anchored on WHO standards, applying equally to wholesalers, community pharmacies and hospital pharmacies, and is rolling out GSDP across the board. GRZAN considers them two faces of one thing: the GBT assesses the institution, the inspection framework governs the objects it regulates. The direct impact: the storage and distribution conditions of the LAR and distributors become inspection targets, and full GSDP rollout means temperature, humidity, batch and distribution records must all be verifiable. This is the same evidence chain as the first Article 7 duty of keeping distribution records and the batch-level traceability requirement in article 45, so companies should build it once, not twice.

4. Practical recommendations

1. Make technical documentation consistency a pre-submission check. GRZAN recommends a cross-module reconciliation before submission: product names, models and intended uses across administrative information, device description, risk management, clinical evaluation and label sections must match word for word.
2. Verify the independence of each RRA approval. For every reference approval, confirm it was granted by the agency’s own review and does not rest on an MRA registration, keeping a written statement.
3. Review pathway eligibility annually. Check each product line’s eligibility for Abridged, EBR, IBR, ECR and EDR every year, covering RRA count, marketing years and the 3-year safety record.
4. Bring LAR and distributor GSDP conditions into annual inspections. Inspect storage temperature and humidity records, batch records and distribution records, with traceability preparation.
5. Time submissions around the evaluation rhythm. During the September 2026 GBT evaluation window, allow longer response time for deficiency letters.
6. Keep a fallback plan when reliance routes are refused. Pre-prepare the full evaluation route dossier, avoiding rushed clinical and verification work when pathway eligibility falls short.

5. Verification checklist

• □ Have product names, models and intended uses across the five CSDT modules been reconciled word for word?
• □ Has every RRA approval been confirmed as granted by the agency’s own review and not based on an MRA registration?
• □ Do each product line’s RRA count, marketing years and 3-year safety record meet the chosen route?
• □ Are LAR and distributor GSDP conditions within annual inspection scope?
• □ Does the submission schedule leave room for deficiency responses during the September 2026 evaluation window?
• □ Is the fallback dossier for the full evaluation route ready if reliance routes are refused?
• □ Are distribution records, GSDP records and batch traceability data merged into one evidence chain?

Regulatory information verified as of October 30, 2026.

In African markets, the GRZAN regulatory team focuses on Kenya, Nigeria, South Africa and Egypt and verifies every published regulatory conclusion against official gazettes, competent authority guidelines and public legal databases, with the verification date marked; figures, cycles and amounts not locatable in official sources are marked as practical estimates, not presumed.

GRZAN services cover market access strategy and risk classification; preparation and review of dossiers in CSDT, STED and CTD formats; selection and management of Local Authorized Representatives (LAR); QMS and GMP/GSDP compliance support; post-market vigilance, change management and recall response; import clearance and PVoC coordination; regulatory intelligence subscriptions and compliance ledgers.

For reliance pathway planning, RRA evidence assessment and GBT-window submissions in Kenya, contact the GRZAN regulatory team at info@grzanglobal.com.