Medical Device Premises Licencing Guidelines

  • 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