ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

4^th October, 2024

PUBLICATION OF MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC DEVICES (IVDDs) ASSESSMENT REPORTS

1. The Tanzania Medicines and Medical Devices Authority (TMDA) hereby informs all Marketing Authorisation Holders (MAHs) and the general public that, in line with its mandate to ensure transparency and provide access to reliable information, TMDA will begin publishing assesment reports (PARs) for registered medical devices and in-vitro diagnostic devices (IVDDs) that meet the established selection criteria.
2. This initiative is aimed at enhancing public access to critical evaluation reports for selected products, ensuring that stakeholders are well-informed about the safety, quality, and performance of registered devices in Tanzania.
3. Only medical devices and IVDDs that meet the following criteria, will be eligible for publication:
   1. a) Treatment or diagnosis of infectious diseases of public interest such as HIV, Malaria, Hepatitis B & C, Syphilis and Tuberculosis.
   2. b) Reproductive health products including those used for contraception and prevention of sexually transmitted infections, and
   3. c) Those used during public health emergencies or at the point of care.
4. Process and Timeline
   1. a) Public Assessment Reports will be published twice a year at the end of the first and second halves of the financial year.
   2. b) Marketing Authorisation Holders of selected products will be notified prior to the publication of their reports to ensure the exclusion of any proprietary or confidential information.
5. For further inquiries or clarifications, please contact TMDA medical devices registration section through email: medicaldevices@tmda.go.tz