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.