Publications

• Fomu ya Utambuzi wa Barakoa na Usajili wa Jengo la Kutengenezea Barakoa Download
• Application Form for Registration of Medical Devices and In Vitro Diagnostics Premises and Business Permit Download
• Notification Form For Class A Medical Devices Download
• Application Form For Variation Of A Registered Medical Devices Including In Vitro Diagnostics Devices Download
• Quality Audit Application Form Download
• Medical devices Adverse Event or Incident reporting Form for Importer or Manufacturers - Light Red Download
• Medical Devices Adverse Event Or Incident Reporting Form For Consumers and Health Facilities Download
• Assessment of Adverse events of Medical Devices and in Vitro diagnostics Download
• Application Form For Approval of Promrotional Materials Download
• Medical Gas Notification form Download
• MDR F 036 Application form for Renewal of a registerd medical device including In Vitro Diagnostic Device Download
• MDR F 034 Application form for registration of in In Vitro Diagnostic Devices Download
• MDR F 033 IVDD Post Market Surveillance Report Submission Form Download
• MDR Checklist 004 -Essential requirement Checklist Download