PPB - Services

Complaints, Feedback and Enquiry

Guidelines on Change Notification for Registered Medical Devices Including In-Vitro Diagnostics

[featured_image]
  • Version
  • Download 244
  • File Size 263.10 KB
  • File Count 1
  • Create Date May 9, 2022
  • Last Updated May 10, 2022

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.

Attached Files

FileAction
GUIDELINES ON CHANGE NOTIFICATION_VARIATION OF REGISTERED MEDICAL DEVICES INCLUDING IN-VITRO DIAGNOSTICS 1.pdfDownload

Author

ppb_admin

Leave a comment

Your email address will not be published.