Kenya medical device registration timeline

Source-linked clocks

Pharmacy and Poisons Board (PPB) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) — EU-aligned classification system.

3 pathways3 of 3 clocks verifiedvalidity 5 years — LN 100 of 2022 rule 10(1), and rule 10(2) keeps a certificate in force past expiry if the renewal application was filed in timeMDSAP not acceptedreviewed 2026-08-30web.pharmacyboardkenya.org

Class / pathway	Review clock	Planning total	With prior approval	Provenance
All classes — first in, first out(PPB marketing authorisation, default queue) PPB publishes its clocks by pathway, not by device class: Fig. 3 gives screening 90 days, scientific review 24 months, approval by the Board 14 days and issue of the registration certificate 7 days	2-2.3 years	2-2.5 years	—	Verified
All classes — fast track (reliance route)(PPB marketing authorisation, priority queue) Fig. 3: screening 30 days instead of 90, and the reliance review is 90 days instead of the FIFO 24 months, with the same 14-day Board approval and 7-day certificate issue	4-5 months	5-9 months	—	Verified
All classes — expedited review (emergency use authorisation)(PPB emergency use authorisation) Fig. 2: screening for completeness 3 days, review 30 days on the full assessment pathway or 7 days for abridged and WHO-listed products, and a final decision in 15 days	25-48 days	1-3 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Kenya Medical Device Registration Process

Step-by-step PPB registration process. Total estimated timeline: 2-2.5 years.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by PPB. Appoint a Kenyan Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to PPB including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

PPB reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

2-2.3 years

In-depth technical assessment of device safety and performance. PPB may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, PPB issues Kenya market authorization certificate.

Summary: The Kenya medical device registration process through Pharmacy and Poisons Board (PPB) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Opens the reliance route inside fast track, which replaces the 24-month FIFO review with a 90-day one

FDA 510(k)/PMARecognised reference-authority decision for the same reliance route

WHO prequalificationWHO-listed products get the 7-day abridged review on the expedited pathway

Key requirements

Local representative appointed by agreement; any variation to that agreement must be notified to the Board within seven days (LN 100 of 2022, rule 4(4))
Rule 5 sets the substantive test — safety, efficacy, quality, performance and economic value — but puts no period on the Board, which is why the clocks come from the PPB pathway chart rather than from the Rules
Applications are filed on the PRIMS portal, which routes them to one of the three pathways at scheduling
Annual retention application and fee under rule 8, separate from the five-year renewal under rule 9
Immediate Class B Registration (IBR) route (guideline 2.4.1.4): a Class B device with at least three reference-agency approvals and four years of safe marketing is registered immediately on submission, listed on the PPB online registry within an hour, with email confirmation within 48 hours

Primary regulator sources

web.pharmacyboardkenya.org · PPB Marketing Authorization Decision Flow chart — Fig. 2 expedited (EUA) and Fig. 3 routine FIFO and fast-track timelines new.kenyalaw.org · The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (Legal Notice No. 100 of 2022) — rule 5 processing, rule 8 annual retention, rule 10 five-year validity

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against PPB publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:kenya:fifo