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Kenya Medical Device Regulations

Agency
The Pharmacy and Poisons Board, regulates medical devices in Kenya.
Medical Device Definition
A medical device in Kenya means Any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, 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 medical purpose(s) 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  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 intended action by pharmacological, immunological, or metabolic means in or on the human body but may be assisted in its intended function by such means.
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
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    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.
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    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.
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    License validity period 5 years
    Fees Class A:
  • Imported Products - 100 USD
  • Local Manufactured - 50 USD
    • Class B:
  • Imported Products - 200 USD
  • Local Manufactured - 50 USD
    • Class C and Class D:
  • Imported Products - 1000 USD
  • Local Manufactured - 100 USD
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