PPB to KHPTA Transition: What Medical Device Registrants in Kenya Should Watch

Content verification date: October 30, 2026

1. Key takeaways

• The Health Products and Technologies Regulatory Authority Bill (formerly the Kenya Drugs Authority Bill, 2022) was passed by the National Assembly in November 2024 and went through its First Reading in the Senate on December 4, 2024.
• The Bill proposes to repeal the Pharmacy and Poisons Board Act and to repeal sections 16, 17 and 18 of the Narcotic Drugs and Psychotropic Substances Act, transferring the assets, liabilities, agreements, pending proceedings and staff of PPB and the National Quality Control Laboratory (NQCL) in their entirety to the newly created Kenya Health Products and Technologies Regulatory Authority (KHPTA).
• The Senate version discussed transitional provisions including the statement that PPB would be dissolved after 24 months; the scope of the Bill expressly covers medical devices, in-vitro diagnostics (IVD) and digital health technologies; the Senate Health Committee is responsible for public participation.
• As of October 30, 2026, publicly searchable information shows that the Bill has not yet completed Senate passage, presidential assent and gazettement; the Pharmacy and Poisons Board (PPB) remains the actual registration authority. GRZAN treats this status as a practical estimate.
• What companies should really watch is not the name of the authority but two items in the transitional provisions: the succession of pending proceedings and the reissuance of existing certificates.

2. Legal basis

3. Expert insights

Insight 1: with the legislation stalled in the Senate, PPB’s current acts remain valid

The stage of the legislative process determines which law applies today. The Bill has completed National Assembly passage and Senate First Reading, but not Senate third reading passage, presidential assent or publication in the Kenya Gazette. Without gazettement the activation requirement is missing and the current order stands: PPB exercises its powers under the Pharmacy and Poisons Act (Cap. 244), LN 100 of 2022 remains the registration rules, and Forms 1 to 8 remain the submission forms. All applications today should go to PPB under the current rules. Preparing dossier materials in the name of KHPTA currently has no legal basis.

Insight 2: the blanket transfer clause is the real gatekeeper of existing certificates

Among the Bill’s provisions, the most easily overlooked yet most consequential is the transfer of the assets, liabilities, agreements, pending proceedings and staff of PPB and the NQCL to KHPTA in their entirety. GRZAN reads pending proceedings to mean that applications, objections and suspension or revocation proceedings unfinished at the transfer date move to KHPTA and continue there. This cuts both ways: no new filing is needed, but the reviewing body and standards may change mid-process. Keep, case by case, the file numbers, receipts and submission dates of every pending project, forming a verifiable evidence chain for procedural continuity after the transfer.

Insight 3: the 24-month dissolution clause sets the transition length, not the intensity of duties

The Senate version contained the wording that PPB would be dissolved after 24 months. GRZAN reads such a clause as fixing the transition length, not reducing any obligation. Even if PPB dissolves within 24 months, certificates issued and decisions made in that period still need an arrangement for continuing validity; there is no relaxed window. On the contrary, institutional change often displays visible enforcement, because a new authority needs demonstrable results to establish authority. Combined with the July 1, 2026 launch of the Inter-sectoral Steering Committee of the National Action Plan on Substandard and Falsified Medical Products, plan transition compliance on a strict reading.

Insight 4: scope expansion to IVD and digital health signals wider review targets

The Bill expressly lists medical devices, IVD and digital health technologies in its scope. GRZAN notes this is not a simple listing but a structural expansion of the regulated object. Bringing digital health into the statute means software-based devices, remote diagnostics and health management products will face clearer classification and requirements; PPB has already launched the National Authentication and Traceability System jointly with the Digital Health Agency in 2026, so technical preparation is ahead of the statute. Companies entering Kenya with software or digital health products should, beyond current PPB registration, track the Bill’s digital health provisions so classification is not redefined unexpectedly under the new law.

4. Practical recommendations

1. Keep receipts for every pending application. GRZAN recommends a file per pending project with the file number, receipt, submission date and payment proof, supporting procedural continuity claims when functions are transferred.
2. Scan and archive existing certificates. High-resolution scan all valid certificates, retention receipts and change approval letters, build a certificate ledger, and record issue dates and validity periods.
3. Subscribe to both parliamentary and gazette sources. The Bill’s activation requirements are parliamentary passage, presidential assent and Kenya Gazette publication; track both the Parliament of Kenya website and the Kenya Gazette.
4. Add an institutional change clause to the LAR agreement. Agree the LAR’s assistance duties when the regulator changes, the mode of cooperation in certificate reissuance, and cost bearing.
5. Prepare transition-period compliance on a strict reading. Combined with the falsified product governance and traceability requirements, complete batch-level traceability preparation within Q4 2026.
6. Assess the scope impact under a future KHPTA. For products with digital health attributes, anticipate reclassification under the new law and prepare software and data compliance materials in advance.

5. Verification checklist

• □ Are file numbers, receipts, submission dates and payment proofs retained case by case for all pending applications?
• □ Have all valid certificates, retention receipts and change approval letters been scanned and archived in a ledger?
• □ Are both the Parliament of Kenya website and the Kenya Gazette subscribed?
• □ Does the LAR agreement include assistance and reissuance clauses for a change of regulator?
• □ Has it been confirmed that the current filing body is still PPB, with no materials submitted in the name of KHPTA?
• □ Has the possible reclassification of digital health and software products under the new law been assessed?
• □ Is transition-period compliance planned on a strict reading, in step with traceability and falsified product governance requirements?

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 transition risk management, certificate continuity and legislative monitoring in Kenya, please contact the GRZAN regulatory team at info@grzanglobal.com.