Labelling and IFU Requirements for Kenya Device Registration

Content verified as of 30 October 2026.

1. Key takeaways

• PPB holds the power to approve and revise labels: under Rule 5(2) of LN 100 of 2022, PPB may approve or revise the sales name, labelling and promotional claims, with the revisable content comprising six items: claims, route of administration, dosage, storage conditions, contraindications/side effects/precautions, and pack size.
• What is submitted is the actual artwork, not a text draft. Item ② of the 9 Class A items requires the proposed label, including packaging materials in contact with the product and/or secondary packaging; item ④ covers the IFU, patient information leaflet and promotional material (including brochures and catalogues).
• The CSDT user information module covers five classes of text: labels, IFU, patient implant cards, surgical manuals and brochures, formally bringing promotional material within the scope of the submission.
• Label and IFU texts submitted to PPB are in English; the trigger conditions and scope of application for Swahili versions are not stated in any specific provision of the current public texts (practical estimate) and must follow the acceptance requirements of PRIMS.
• The label is the object of the statutory duty under Section 41 of Cap. 244; devices registered under compassionate use are likewise labelled under Section 41.

2. Legal basis

3. Expert insights

Insight 1: The label approval power is a power to revise, not to negotiate. Rule 5(2) says PPB may approve or revise — a one-way discretion. The label text a company submits is not the final version but the version awaiting approval; PPB can directly amend non-compliant wording rather than return it for the company to fix. The misreading is common: many companies treat the label as an afterthought finalised by the marketing function near the end of registration, then find the revised text inconsistent with the global version and trigger a headquarters approval loop. GRZAN recommends finalising the Kenya label at the technical documentation stage and accepting in advance that it may be revised.

Insight 2: Artwork rather than a text draft means layout and hierarchy are also reviewed. Class A item ② expressly requires the proposed label as actual artwork, extending to packaging materials in contact with the product and/or secondary packaging. In practice this means font size, symbol use, language arrangement and the completeness of information on secondary packaging all come within review scope. Frequent defects: secondary packaging missing the legal manufacturer name and address or the batch identifier, or artwork inconsistent with the CSDT administrative information module. GRZAN recommends organising the evidence by label level: submit artwork separately for primary packaging, secondary packaging and outer carton, with a comparison table stating which elements each level carries.

Insight 3: The six revisable items are six categories of burden of proof. The six items listed in Rule 5(2) — claims, route of administration, dosage, storage conditions, contraindications/side effects/precautions, and pack size — amount to a list of proof obligations: each must be supported by corresponding technical or clinical evidence. LN 98 of 2022 added a definition of medical claims and rules and prohibitions for device advertisement and promotion, extending the boundary of promotional claims from the label to advertising material. Where exhibition material or distributor brochures go beyond the approved label, the risk no longer sits only in the registration process but lands on the general penalties of LN 98 of 2022.

Insight 4: Handle language requirements through the acceptance channel. English as the working language of the submission and label is standard practice in projects; the scenarios in which Swahili applies, and whether patient-facing instructions need a local language version, are not given any citable provision in the current public guideline texts. GRZAN treats this as a practical estimate: before submission, confirm the language requirements for the specific application through PRIMS with the PPB medical devices unit, and keep the confirmation on file as the comparison baseline for later label changes and renewal.

4. Practical recommendations

1. Finalise the label early. GRZAN recommends scheduling Kenya label and IFU finalisation at the technical documentation stage rather than the closing stage of registration.
2. Submit artwork by three packaging levels. Submit primary, secondary and outer packaging separately with an information item comparison table.
3. Treat the six revisable items as a proof checklist. Prepare evidence sources for every claim, dosage, storage condition and precaution.
4. Bring promotional material into the review scope. Brochures, catalogues and exhibition material must not exceed the approved label, avoiding the prohibited advertising situations of LN 98 of 2022.
5. Confirm language requirements before finalising. Obtain written confirmation from PPB on the application of English and Swahili before submission and keep it on file (practical estimate).
6. Route label changes through change notification. Amendments to an approved label fall in the prior-approval change category; do not release a new version on your own.

5. Verification checklist

• □ Has the approval application for the sales name, labelling and promotional claims been prepared under Rule 5(2)?
• □ Has supporting material been prepared item by item against the 6 revisable content items?
• □ Does the label artwork cover primary packaging, secondary packaging and the outer carton?
• □ Are the manufacturer name and address on the artwork consistent with the CSDT administrative information module?
• □ Have the IFU, patient information leaflet, patient implant card, surgical manual and brochures been submitted together?
• □ Have brochure and catalogue statements been reviewed so as not to exceed the approved label?
• □ Has the language plan been confirmed with PPB and kept on file (practical estimate)?
• □ Are later label changes known to route through change notification and prior approval?

Regulatory information verified as of 30 October 2026.

In African markets, the GRZAN regulatory team focuses on jurisdictions such as Kenya, Nigeria, South Africa and Egypt and maintains a verification mechanism built on primary regulatory sources. Every regulatory conclusion it issues rests solely on official gazettes, the original text of competent authority guidelines and public legal databases, with the verification date stated; any figure, timeline or amount that cannot be located in an official source is marked as a practical estimate and is never presented as presumption.

GRZAN services cover market access strategy and risk classification; preparation and review of registration dossiers in CSDT, STED and CTD formats; selection and management of local authorized representatives (LARs); 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 for a specific product, contact the GRZAN regulatory team at info@grzanglobal.com.