This document summarizes guidelines for registering medical devices in Kenya. It defines medical devices and in vitro diagnostic devices. It outlines the medical device lifecycle and registration requirements, including submitting documentation using the Common Submission Dossier Template format through the Pharmacy and Poisons Board's online portal. It describes risk-based classification of devices into Classes A, B, C and D and the various evaluation routes for registration based on a device's class and prior approvals in reference regulatory authorities. Exceptions for certain higher-risk devices are also noted. Contact information is provided for the Pharmacy and Poisons Board.