Administrative Information in the Kenya CSDT: Entity Consistency and POA

Content verified as of 30 October 2026.

1. Key takeaways

• Administrative information is the first CSDT module and the one with the highest concentration of deficiency letters. It simultaneously involves three parties: the applicant, the legal manufacturer (LM) and the local authorized representative (LAR).
• The manufacturer name and address must match verbatim the wording on the device label and the declaration of conformity. Discrepancies between building number, floor, registered seat and physical address all attract written explanation requests.
• A manufacturer outside Kenya must appoint an LAR, and only one; the appointment must be consistent with the device label and the declaration of conformity.
• The LAR appointment requires written consent from the manufacturer (authorisation letter template in Annex 1), and the LAR itself must hold a licence to deal in medical devices (including IVDs) in Kenya; otherwise the licensing chain under Rule 5(4) of LN 100 of 2022 breaks.
• Item ① of the nine Class A documents is the authorisation letter, while the twelve Class B/C/D documents carry a separate entry for manufacturer information (including manufacturing sites); the two tiers describe the parties at different depth.

2. Legal basis

3. Expert insights

Insight 1: Consistency is a three-way interlock, not a two-way comparison. Companies most often underestimate the complexity of this module. Consistency is not a matter of checking the administrative information against the label: the label, the declaration of conformity and the CSDT administrative information interlock, supported by three further documents — the authorisation letter, the establishment registration certificate and the import licence. Six documents must point to the same entity. The GRZAN approach is to build a master data table of entity names, addresses and entity numbers as the single source of values for all documents; any change is made first in the master data and then propagated downstream.

Insight 2: Legal manufacturer, manufacturing site and brand owner are three different concepts. This is where two readings diverge. The legal manufacturer is the entity that places the device on the market and bears responsibility for its design, manufacture, packaging and labelling; the manufacturing site is a physical location and may be multiple; the brand owner (private label or OEM arrangement) is not automatically the legal manufacturer in the Kenya submission context. Under group structures companies often enter a regional headquarters or trading company in the manufacturer name field; where this differs from the legal manufacturer on the label, PPB will ask for the relationships among the three. A workable approach: enter only the legal manufacturer in the administrative information, list all manufacturing sites in the manufacturing process and subcontractors module, and disclose submissions of the same device under other entities in the related prior submissions module.

Insight 3: The signatory and date of the authorisation letter are frequent rejection points. The authorisation letter must be signed by the legal manufacturer in favour of the LAR, not by a trading company or regional sales centre. Three defects recur: the signatory lacks corporate authority, the authorisation period has expired or is about to expire, and the scope does not cover all models intended for registration. GRZAN recommends that the letter state the authorisation period, the product scope and the assumption of the LAR’s 10 duties, so that change management does not decouple later.

4. Practical recommendations

1. Build an entity master data table. With GRZAN support, fix the legal manufacturer name and address, manufacturing sites, LAR name and licence number as the single source of values, referenced by all downstream documents.
2. Have the authorisation letter signed by the legal manufacturer. Attach proof of the signatory’s signing authority, and set the authorisation period to cover the 5-year validity of the certificate with margin.
3. List multiple manufacturing sites separately. Enter only the legal manufacturer in the administrative information field and place all sites, with an address list, in the manufacturing process and subcontractors module.
4. Explain private-label arrangements up front. Where the brand owner and the legal manufacturer differ, prepare a relationship statement and a summary of the quality agreement.
5. Run a three-way consistency check before submission. Compare label artwork, the draft declaration of conformity and the CSDT administrative information verbatim.
6. File the entity change first after a group rename or merger. A change of entity name is an administrative change requiring prior approval; it must not be slipped into a new submission quietly.

5. Verification checklist

• □ Have the applicant, legal manufacturer and LAR been identified separately with credentials on file?
• □ Do the manufacturer name and address match the label artwork and the draft declaration of conformity verbatim?
• □ Is the authorisation letter signed by the legal manufacturer, with proof of signing authority, and does its term cover the 5-year certificate period?
• □ Does the product scope of the authorisation letter include all models and configurations intended for registration?
• □ Does the LAR hold a licence to deal in medical devices (including IVDs) in Kenya?
• □ Does the applicant hold a valid licence under Sections 9A/27/35A of Cap. 244 (corresponding to Rule 5(4))?
• □ Are all manufacturing sites fully listed in the manufacturing process and subcontractors module?
• □ Where private labelling applies, is the relationship between brand owner and legal manufacturer documented in writing?

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.