ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

8^th July, 2022

NOTICE TO ALL MEDICAL DEVICES AND DIAGNOSTIC DEALERS ON RE- REGISTRATION AND RE- NOTIFICATION OF MEDICAL DEVICES AND IN VITRO DIAGNOSTIC DEVICES

1. TMDA would like to remind its esteemed stakeholders that validity of registration and notification of Medical Devices and In Vitro diagnostics is five (5) years and three (3) years respectively, after which re- registration/notification is required as prescribed under Section 17 of the Tanzania Medicines and Medical Devices (Control of Medical Devices) Regulations, 2015.
2. In view of this, We call upon all medical devices and diagnostics dealers to submit applications for re- registration/notification of all devices whose market authorization validity has expired.
3. Please note that, failure to re-apply for market authorization for these devices will hinder importation of the same into the country.
4. For further enquiries, contact us through medicaldevices@tmda.go.tz.
5. We anticipate your cooperation in this matter.