ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

29^th July, 2022

NEW GUIDELINES ON APPLICATIONS FOR NOTIFICATION OF 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 Notification of Medical Devices Exempted from Registration. These guidelines were developed to provide detailed requirements for submitting applications for marketing authorization of products that do not require registration.
2. This new publication outlines the requirements for notification of medical devices and in vitro diagnostic devices exempted from registration, devices for veterinary use and medical gases. All applicants are required to accurately classify their devices and consult this guideline before lodging applications for notification. Information on the classification of medical devices and in vitro diagnostic devices is detailed in the Guidelines on Submission of Documentation for Registration of Medical Devices, 3rd Edition 2020 and Guidelines on Submission of Documentation for Registration of In Vitro Diagnostic Devices 3rd Edition, 2020.
3. This notice is to inform you that, with effect from 1st August 2022, all applications for notification should be made in accordance with the requirements prescribed in these guidelines.
4. To access these guidelines, please click here.
5. For more information, please contact the Authority through the following email address medicaldevices@tmda.go.tz.