Local Authorized Representative in Kenya: Appointment, Duties and Replacement

Content verified as of 30 October 2026.

1. Key takeaways

• A manufacturer outside Kenya must appoint a local authorized representative (LAR), and must obtain written consent from the manufacturer (authorisation letter template in Annex 1).
• Only one LAR may be appointed, and the appointment must be consistent with the device label and the declaration of conformity; the same product line or product family must not have two or more LARs.
• The LAR carries 10 duties: primary point of contact with the authority, keeping technical documentation available, confidentiality, adverse event and incident reporting, supply chain compliance, product safety vigilance reporting, implementation, management, coordination and reporting of FSCAs, assistance with technical documentation, annual review of technical documentation, and notification of regulatory changes.
• The LAR must hold a licence to deal in medical devices (including IVDs) in Kenya; an unlicensed representative cannot support the issue of a registration certificate.
• Transfer or replacement of the LAR requires a copy of the initial PPB registration certificate, a copy of the certificate retained by PPB, and a letter of no objection from the incumbent local technical representative (LTR).

2. Legal basis

3. Expert insights

Insight 1: The 10 duties split into existence duties and continuity duties. The first three — primary point of contact with the authority, keeping technical documentation available, and confidentiality — are capabilities needed at establishment and are existence obligations. The remaining seven — adverse event and incident reporting, supply chain compliance, product safety vigilance reporting, implementation, management, coordination and reporting of FSCAs, assistance with technical documentation, annual review of technical documentation, and notification of regulatory changes — are mechanisms that must run every day during the life of the certificate and are continuity obligations. GRZAN due diligence concentrates on the latter seven: a company that only does customs clearance and warehousing can perform the first three but cannot run adverse event reporting or FSCA coordination. A wrong choice of representative does not surface at acceptance; it surfaces at the first post-market complaint.

Insight 2: Exclusivity combined with one representative per product line is a real difficulty for group structures. The prohibition on appointing two or more LARs for the same product line means a group cannot spread risk by having several distributors each hold certificates. Where readings diverge is how to slice the product line: by risk class, by brand, or by therapeutic area. The guidelines anchor on the same product line or product family; GRZAN’s judgement is that dividing by device function and intended use is more defensible, fixed in a written product line division list and stated in the authorisation letter as the representative’s scope. Where a group runs several brands in parallel, the division plan should be settled before submission and kept consistent, so that later model additions are not treated as duplicate appointments.

Insight 3: The letter of no objection gives the incumbent representative a substantive veto. Replacing an LAR requires a letter of no objection from the incumbent LTR. This document is evidence of a commercial relationship, not an administrative formality. If a dispute arises between the manufacturer and the incumbent over commissions, stock or market investment, the registration relationship is frozen along with it. GRZAN’s negotiating advice: provide in the authorisation agreement in advance for the duty to issue the letter, its trigger conditions and the consequences of breach, and agree on a transition period and a document handover duty after termination. The Rule 14 obligation to notify PPB within 7 days of any change to the representation agreement should likewise be internalised as an operating clause.

4. Practical recommendations

1. Due diligence before signing. GRZAN recommends verifying four items before signing the authorisation letter: scope of the business licence, vigilance and complaint handling capability, whether the line is already occupied by another principal, and conditions for storing technical documentation.
2. Write the 10 duties into the agreement. Specify the service content, response timelines and document handover duties item by item, rather than a bare arrangement to handle registration.
3. Fix the product line division list in writing. State in the authorisation letter the product lines covered and excluded, as the test for later model additions.
4. Design the exit mechanism in advance. Provide for the duty to issue the letter of no objection and for damages on breach, and agree the handover process for technical documentation and vigilance records after termination.
5. Keep an annual review ledger. Corresponding to the annual review of technical documentation duty, retain one review record and update statement each year.
6. Assemble the three documents before any replacement. A copy of the initial PPB registration certificate, a copy of the certificate retained by PPB, and the incumbent LTR’s letter of no objection; without any one of them the change cannot proceed.

5. Verification checklist

• □ Has the overseas manufacturer appointed an LAR with a written authorisation letter in the Annex 1 format?
• □ Has it been confirmed that only one LAR is appointed, with no duplicate appointment within the same product line?
• □ Does the LAR hold a licence to deal in medical devices (including IVDs) in Kenya, and is it within validity?
• □ Does the authorisation agreement cover the 10 duties and set response timelines?
• □ Is the product line division list fixed in writing and consistent with the scope of the authorisation letter?
• □ On replacement of the LAR, are the copy of the initial PPB registration certificate, the copy of the certificate retained by PPB and the incumbent LTR’s letter of no objection all in hand?
• □ Where Rule 14 applies, has PPB been notified within 7 days of the change to the representation agreement?
• □ Has the LAR completed the annual review of technical documentation and retained the record?

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.