ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

29^th July, 2022

NEW GUIDELINES ON APPLICATIONS FOR CHANGES TO REGISTERED MEDICAL DEVICES AND IN VITRO DIAGNOSTIC DEVICES, 1ST EDITION, 2022

1. Tanzania Medicines and Medical Devices Authority (TMDA) would like to introduce to its esteemed stakeholders, the First Edition of the Guidelines on Submission of Application for Change(s) to Approved Medical Devices and In-Vitro Diagnostics. This is the first publication of guidelines developed to provide instructions on how to apply for changes to registered medical devices, in vitro diagnostic devices and laboratory equipment.
2. This new publication provides guidance to applicants on the classification of changes as well as the technical requirements to support their applications. Applicants are encouraged to consult the guidelines prior to lodging applications for changes to their products. These guidelines should be read in conjunction with other applicable guidelines including the Guidelines on Submission of Documentation for Registration of Medical Devices, 3rd Edition, April 2020 and Guidelines on Submission of Documentation for Registration of In Vitro Diagnostic Devices, 3rd Edition, April 2020.
3. This notice is to inform you that, with effect from 1st August 2022, all submissions for changes to registered medical devices and in vitro diagnostic devices should be made in accordance with the requirements prescribed in these guidelines.
4. For more information, please contact the Authority through the following email address medicaldevices@tmda.go.tz.