TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

31^st January, 2020

PILOT TESTING OF ONLINE SYSTEM FOR SUBMISSION OF APPLICATIONS FOR REGISTRATION OF MEDICAL DEVICES, PREMISES, CLINICAL TRIALS AND GOOD MANUFACTURING PRACTICES (GMP) INSPECTIONS

1. The TMDA wishes to inform its esteemed customers and the general public that it is in the process of switching to an online submission system of applications for registration of medical devices, premises, clinical trials and GMP following the successful development of the system. However, before migrating fully to the online submission system TMDA would like to involve customers in testing the system for a period of three (3) months from 1st February, 2020.
2. In this regard, applicants submitting applications for registration of medical devices (new, renewal and variation), premises, clinical trials and good manufacturing practices with effective from above mentioned date are requested to submit their applications through the new online system. Applicants or Local Technical Representatives (LTRs) may register in the system and obtain the credentials to get access to the system through the link Online Portal Version Two
3. You are kindly requested to follow the instructions provided on the portal. In case of difficulties in following up the instructions, you may contact the following TMDA staff for support;
   Fabian Lwanole [Phone: +255 762 533 530, Email: fabian.lwanole@tmda.go.tz]
   Salehe Mwenyevyale [Phone: +255 753 747 474, Email: salehe.mwenyevyale@tmda.go.tz]
   David Mwakyoma [Phone: +255 658266200, Email: david.mwakyoma@tmda.go.tz]
   Office Email: mis@tmda.go.tz
4. It should be noted that during this pre-testing phase, applicants will also be required to submit same applications physically at the TMDA Offices, EPI Mabibo External Ubungo, Dar es Salaam until when the Authority announces a full switch to an online submission system. It should further be noted that pilot testing for online submission of application for medicines registration is still going on.
5. We thank you for your continued cooperation.