Track and Trace and Serialisation for Medical Devices in Kenya

Content verification date: October 30, 2026

1. Key takeaways

• Kenya’s three national digital platforms, the Kenya National Authentication and Traceability System, Practice360 and Facility360, officially went live from August 3, 2026, first achieving batch-level traceability and transitioning to full serialisation on January 1, 2027.
• The onboarding deadline is October 31, 2026, officially stated as non-extendable and non-negotiable; those who fail to complete onboarding will not be issued 2027 practice licences and premises licences. This ties traceability compliance directly to operating eligibility.
• Two official statements differ on dates, and the difference must be stated honestly: the Ministry of Health announced on June 24, 2026 at the 46th Annual Scientific Conference of the Pharmaceutical Society of Kenya that the platforms would operate from July 1, 2026; PPB chair Dr. John Munyu announced on July 30, 2026 at the 22nd Kenya Association of Pharmaceutical Industry Scientific Conference in Mombasa that they would officially go live from August 3. GRZAN treats the difference as a practical estimate and recommends following PPB’s formal notices.
• Traceability is not isolated; it links to existing duties under LN 100 of 2022: Rule 3 prohibits circulation of unregistered products, Section 2.13 requires immediate cessation of importation and supply after revocation, and the first Article 7 duty requires manufacturers and the LAR to keep distribution records for device accountability and traceability. Serialisation is the technical upgrade of those duties.
• The window is tight: only 1 day remains to the onboarding deadline and about 2 months to full serialisation, so companies must start on the tightest reading.

2. Legal basis

3. Expert insights

Insight 1: two agencies giving different dates is itself a risk signal

GRZAN treats this difference as a compliance input, not a footnote. The Ministry of Health statement of June 24 put operation at July 1, 2026, while the PPB statement of July 30 put the official launch at August 3. Whatever the cause, the conclusion is the same: do not rely on either date alone; follow PPB’s formal notices and prepare against the earliest date. More importantly, it signals the platforms’ detailed rules are still being adjusted and field and interface specifications may not be frozen, so companies should keep data models flexible.

Insight 2: batch-level first is not a buffer period but a parallel period

Only 5 months separate batch-level traceability from full serialisation. GRZAN’s judgement: this period should be used not to work at batch level and switch in 2027, but to clean and align master data. It must resolve: whether product GMDN codes and device subcategories match the register, whether batch numbering rules are unique, whether production and import batches can be linked, and whether distributor and premises codes have been obtained. These are serialisation preconditions; leave them to December 2026 and the switch cannot happen directly on January 1, 2027.

Insight 3: onboarding is an entity eligibility action, not a technical integration action

In the official statements, the onboarding duty falls on practitioners and facilities, with the consequence of denial of 2027 practice and premises licences. The onboarding target is therefore the licensed entity, premises and practitioners, not each product. GRZAN notes a common mistake: manufacturers assume a barcode on the product is enough, ignoring the onboarding duties of local licensed entities such as the LAR and distributors. If the LAR or a key distributor fails to onboard, the entity is stuck at the 2027 licensing stage and the whole chain’s import and distribution capacity suffers. Onboarding should be driven by the licensed entity list, not the product list.

Insight 4: the four fronts of serialisation transformation must advance together

GRZAN splits the transformation into four fronts. Identification: whether the device identifier and production identifier of the Unique Device Identification (UDI) appear on the label and match the GMDN code and register entry. Packaging: whether the print position, readability and packaging hierarchy of unit-level coding match the carrier to be used. Data: whether batch master data, inventory movement events and flow records can be output in the fields the platforms require. Process: whether scanning events can be captured across import, warehousing, distribution, returns and recall. Packaging redesign and print supplier switching take longest and should start first.

4. Practical recommendations

1. Check onboarding status of licensed entities immediately. GRZAN recommends the LAR list all local licensed entities, premises and practitioners, confirm onboarding receipts, and complete missing ones at once.
2. Build a batch master data dictionary. Unify GMDN codes, device subcategories, brand names, family names and batch numbering rules so every field matches the PPB register entry.
3. Start packaging redesign first. Unit-level coding involves print suppliers and tooling changes, the longest cycle; complete prototyping and verification within Q4 2026.
4. Keep the data model flexible. Since the platforms’ detailed rules are not yet formal written law, field and interface design should use configurable structures, avoiding a rebuild when specifications change.
5. Set scanning capture points. Set scanning points across import, warehousing, distribution, returns and recall, captured together with the FSCA and distribution record ledgers to avoid duplicated investment.
6. Schedule a switch drill for January 1, 2027. Complete one full serialisation mock submission in 2026 to verify the data chain.

5. Verification checklist

• □ Have all local licensed entities and practitioners obtained onboarding receipts for the three platforms?
• □ Is the batch master data dictionary built and checked field by field against the PPB register?
• □ Is the unit-level packaging coding design finalised, prototyped and verified?
• □ Do the UDI and GMDN codes on labels match the register?
• □ Are scanning capture points set across the five process stages and merged with the distribution ledger?
• □ Is the data interface built on a configurable structure to absorb specification changes?
• □ Has one full serialisation mock submission drill been completed within 2026?
• □ Are PPB’s formal notices on the three platforms subscribed, with a date-difference recheck mechanism?

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 platform onboarding, serialisation planning and traceability readiness in Kenya, contact the GRZAN regulatory team at info@grzanglobal.com.