THE UNITED REPUBLIC OF TANZANIA
MINISTRY OF HEALTH
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
ISO 9001: 2015: CERTIFIED
25th 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
- 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.
- 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.
- Before applying for registration through CRP pathway, please note the following;
- 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);
- 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);
- 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;
- Furthermore, requirements for TMDA online submission and fees for registration of in-vitro diagnostic devices remains the same.
- 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 email@example.com.
- Thank you for your cooperation.
Tanzania Medicines and Medical Devices Authority (TMDA),
P. O. Box 1253, Dodoma
Or P. O. Box 77150, Dar es Salaam
Phone +255 22 24521108/2450512/245071
Toll free: 0800110084