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Guidelines on Change Notification for Registered Medical Devices Including In-Vitro Diagnostics

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  • Create Date May 9, 2022
  • Last Updated May 10, 2022

Guidelines on Change Notification for Registered Medical Devices Including In-Vitro Diagnostics

Medical devices are classified into four risk classes (A to D) based on the classification rules set out in guideline for registration of Medical Devices IVDs. Class A represents the lowest risk medical devices and Class D represents the highest risk medical devices.

These guidelines to Change Notification are based on the principles of safety, quality and efficacy of medical devices supplied in Kenya. Changes to a medical device can affect its safety, quality or efficacy and must be approved prior to the modified device being supplied in Kenya, unless otherwise indicated.

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GUIDELINES ON CHANGE NOTIFICATION_VARIATION OF REGISTERED MEDICAL DEVICES INCLUDING IN-VITRO DIAGNOSTICS 1.pdfDownload

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