Official
Competent authority
National authority responsible for medical-device oversight.
2 linked sources
PPB · official source indexKenya medical device regulatory sources
Start with the competent authority, submission surface, official forms, and source coverage we have verified for Kenya.
8 dimensions sourced2 official sources2026-08-13 reviewed
Official starting point
Pharmacy and Poisons Board (PPB)
PPB online services portal plus statutory Form 1 and dossier
Coverage boundary
This is an official-source spine, not a completed market-access rulebook. It identifies where to begin and shows which dimensions still need detailed extraction.
Structured coverage
Nine regulatory research dimensions
Each status is source-bound. A located page is useful for research, but it does not turn adjacent requirements into verified facts.
Official
Legislation & guidance
Primary law, regulation, or official implementation guidance.
1 linked source
Official
Registration & submission
Official route used to register an operator or submit a device.
1 linked source
Official
Official forms
Current authority forms, filing templates, or online form surface.
1 linked source
Official
Label, IFU & language
Official surface for labeling, instructions for use, and language rules.
1 linked source
Research needed
UDI & traceability
Official UDI, device identification, or traceability surface.
0 linked sources
Official
Post-market & vigilance
Incident reporting, vigilance, safety action, and recall surface.
1 linked source
Official
Import & establishment
Importer, local operator, establishment, or market-entry surface.
1 linked source
Official
Renewal & change
Renewal, variation, amendment, transfer, or discontinuation surface.
1 linked source
Source highlights
What the reviewed surfaces indicate
- The current rules contain the application, local-representative, dossier, variation, renewal, validity and fee structure.
- Medical-device certificates are valid for five years under the rules.
Primary evidence
Official sources
World Health Organization
WHO Global Atlas of Medical Devices 2022
Discovery baseline only; country information was mainly collected in 2021–2022 and is not treated as current law.
Pharmacy and Poisons Board (PPB)
Pharmacy and Poisons (Registration of Health Products and Technologies) Rules
Current official surface used as a bounded starting point; it is not a complete rule table.
Official source indexes in other markets
Other Middle East & Africa markets
Algeria
Ghana
Iran
Iraq
Jordan
Nigeria
Oman
Qatar
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