Medical Device Registration and Approval in Kenya
General country-specific regulatory information is provided on this page for medical device registration and approval in Kenya.
Last updated on November 5th, 2021.
Medical Device Regulations and Classification in Kenya
REGULATORY AUTHORITY: The regulatory authority in Kenya is the Pharmacy and Poisons Board (PPB).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes A-D, with A being the lowest risk and D being the highest.
TIMEFRAME: New Registration (full and abridged evaluation route) will take up to 12 months.
SPECIAL REQUIREMENTS: Foreign manufacturer on-site audit, local test, or local clinical study is not required.
LOCAL FEES: N/A
LICENSE VALIDITY: Licenses issued in Kenya expire after five years. However, annual retention is required.
LICENSE TRANSFER: license transfer is possible; the registration and timeline for this process will follow the license amendment procedure. However, a non-objection letter from the current LAR is required.
AUTHORIZED REPRESENTATIVE: Any manufacturer based outside Kenya must designate a local authorized representative (LAR) who is responsible for assuring regulatory compliance and serving as the central communication pathway with the PPB and also the holder of the registration certificate.
For Class A medical devices, only listing is required.
For Class B, C, and D medical devices, the following routes are applicable:
- Full Evaluation Route
- Abridged Evaluation Route
- Expedited Evaluation Route
- Immediate Evaluation Route
Full evaluation route is applicable for a medical device that has not obtained any prior approval from any Reference Regulatory Agencies at the point of application.
The abridged, expedite and immediate evaluation routes are set out according to a confidence-based approach, leveraging on the approvals by listed medical device reference regulatory agencies (8) and/or prior safe marketing history.
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