Medical Device Premises Licencing Guidelines

• Guidelines for Importation and Exportation of Medical Devices Including In Vitro Diagnostics, Laboratory Equipment and Raw Materials Download
• Guidelines for Handling Unfit Medical Devices and Diagnostics Download
• Guidelines on Submission of Documentation for Quality Audit of Medical Devices and Diagnostics Manufacturing Sites Download
• Guidelines for Premises Licensing and Good Distribution and Storage Practices Download
• Guidelines for Importation and Exportation of Medical Devices including In Vitro Diagnostics and Laboratory Equipment, April 2020 Download
• Guidelines on Submission of Documentation for Establishment of Compliance to GMPand QA of Medical Devices through Desk Assessment, March 2021 Download
• Mwongozo kwa Watengenezaji wa Barakoa za Vitambaa nchini Download
• Guidelines for Regulating Medical Gases,Second Edition, April 2020. Download