ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

25^th July, 2022

NOTICE TO ALL MEDICAL DEVICES AND DIAGNOSTIC DEALERS ON REGISTRATION OF IN VITRO DIAGNOSTIC DEVICES (IVDs) UNDER THE COLLABORATIVE REGISTRATION PROCEDURE (CRP) PATHWAY

1. The Authority wishes to bring to the attention of our esteemed stakeholders the procedure for accelerated registration of In-vitro diagnostic devices through Collaborative Registration Procedure (CRP) pathway. This procedure applies to all In-vitro diagnostic devices which have been prequalified by WHO.
2. This is in effort of the Authority to harmonize the globally acceptable formats for submission of technical documentation (dossier) for In-vitro diagnostic devices, and to shorten the time taken for approval of such products. The procedure will offer timely accessibility without compromising the product’s safety, quality and performance.
3. Before applying for registration through CRP pathway, please note the following;
   1. Applicants should voluntarily express interest in applying the procedure for accelerated registration of their prequalified products by filling the WHO expression of interest form (Appendix 3);
   2. Applicants should authorize WHO to share its assessment and inspection outcomes for the specific product(s), with TMDA by filling the who consent form (Appendix 2);
   3. An applicant must submit the same dossier to TMDA as the one approved by WHO for prequalification, along with TMDA application form for registration and Appendix 3 form;
4. Furthermore, requirements for TMDA online submission and fees for registration of in-vitro diagnostic devices remains the same.
5. For further enquiries and in order to access WHO concert form - Appendix 2, and WHO expression of interest form - Appendix 3 forms contact us through TMDA email medicaldevices@tmda.go.tz.
6. Thank you for your cooperation.