MEDICAL DEVICE REGISTRATION AND APPROVAL IN Kenya

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 update: May 2023

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 (New Application):

New product registration (Class A): USD 100

New product registration (Class B): USD 200

New product registration (Class C): USD 1000

New product registration (Class D/ Devices incorporating medicinal products): USD 1000.

LOCAL FEES (Change Notification): 

Change Notification (Class A): USD 200

Change Notification (Class B): USD 200

Change Notification (Class C): USD 200

Change Notification (Class D/ Devices incorporating medicinal products): USD 200.

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.

 

ADDITIONAL INFORMATION: 

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.

Other Sub-Saharan African Countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Comoros, Congo, DR Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea – Bissau, Ivory Coast, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo, Zanzibar

Last update May 01 2023

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