Market
Kenya
3 articles
Regulatory
Kenya PPB Retained Medical Devices Teardown: Manufacturers & LTRs
A data-driven teardown of Kenya's PPB retained medical devices register. Analyze the manufacturer landscape and local technical representative concentration.
18 min read2026-07-01
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SaMD
Software as a Medical Device (SaMD) Regulation Compared: SFDA, ANVISA, NAFDAC, PPB
Compare how Saudi SFDA MDS-G23, Brazil ANVISA RDC 657/2022, Nigeria NAFDAC and Kenya PPB regulate Software as a Medical Device — definitions, risk classes, and filing routes.
12 min read2026-06-16
›Regulatory
Kenya Medical Device Registration Guide: PPB Process, Fees and Requirements
Register medical devices in Kenya through the PPB, covering Class A-D classification, evaluation routes, reliance pathways, local representative duties, import permits, QMS audits, and surveillance.
18 min read2026-04-30
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