Kenya Medical Device Regulations

Regulatory Agency

The Pharmacy and Poisons Board, regulates medical devices in Kenya.

Medical Device Definition

Medical Device: Any instrument, apparatus, machine, appliance, implant, in vitro reagent, software, material, or another similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific of:

Diagnosis, prevention, monitoring, treatment, or alleviation of disease
Diagnosis, monitoring, treatment, and alleviation of or compensation for an injury
Investigation, replacement, modification, or support of the anatomy or of a physiological process
Supporting or sustaining life
Control of conception
Disinfection of medical devices
Providing information for medical or diagnostic purposes by means of an in vitro examination of specimens derived from the human body
Disinfection substances
Aids for persons with disabilities
Devices incorporating animal and/or human tissues
Devices for in-vitro fertilization or assisted reproduction technologies and which does not achieve its primary in or on the human body intended action by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

Active Medical Devices: any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy.

Medical Device Classification System

International Classification	Risk Level	Examples
Class A	Low risk	Cotton wool, bandages, urine collection bottles; compression hosiery; noninvasive electrodes, hospital beds.
Class B	Low–moderate risk	Urinary catheters, tracheal tubes. Orthodontic materials, removable dental prosthesis
Class C	High- Moderate risk	Urethral stent; contact lenses for longterm continuous use Catheter containing sealed radioisotopes
Class D	High risk	Pacemakers; Implantable defibrillators. Prosthetic heart valves; cardiovascular stents; pacemaker leads and electrodes; deep brain stimulation electrodes; cerebrospinal catheter.

Regulatory Approval Process

Classification	Approval procedure
Class A	The required documents should be submitted online via the Online Portal of the Pharmacy and Poisons Board, prims.pharmacyboardkenya.org, along with the fee (charged immediately). If more information or clarity is needed, the applicant will receive an input request. Applications will only be registered and listed if they meet the registration conditions.
Class B	For Class B medical devices, there are four possible evaluation paths: Full Evaluation Route Abridged Evaluation Route Expedited Class B Registration (EBR) Evaluation Route Immediate Class B Registration (IBR) Evaluation Route The documents should be submitted via the PPB website (portal.pharmacyboardkenya.org), after which the medical device is immediately registered and entered into the PPB online registry within one hour. An email notifying the successful registration of the device will be sent within 48 hours of submission in PPB online Portal. The fees will also be charged at this point.
Class C	For Class C and Class D medical devices, there are four possible evaluation paths: Full Evaluation Route Abridged Evaluation Route Expedited Evaluation Route Expedited Class C Registration (ECR) Expedited Class D Registration (EDR) Upon submission via PPB Online Portal, an application fee will be charged immediately and the documents will be verified for their completeness. Once confirmed, the application will be accepted for evaluation. The evaluation fees will be charged at this point. Applications will only be registered and listed if they meet the registration conditions.
Class D
Note: An authorized representative is required for the foreign manufacturers.

Additional Information

Approval timeline

Upon submission via PPB online Portal (portal.pharmacyboardkenya.org), the medical device will be registered immediately and will be listed on the PPB Online registry within an hour.
The stop-clock starts whenever PPB issues an input request and ends when PPB receives a complete and satisfactory response from the applicant.
The target turn-around-time (TAT) for product registration applications starts from the date of receipt of the application and does not include ‘stop-clock time’ due to input requests for clarifications and additional information.

License validity period

5 years

Fees

Class A:

100 USD

Class B:

200 USD

Class C and Class D:

1000 USD

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