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Posted On: Oct 19, 2024


THE UNITED REPUBLIC OF TANZANIA

MINISTRY OF HEALTH

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY




ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

9th October, 2024

NEW GUIDELINES FOR CONTROL OF MEDICAL DEVICES AND DIAGNOSTICS

  1. The Tanzania Medicines and Medical Devices Authority (TMDA) wishes to inform its esteemed Stakeholders that, it has crafted three (3) new guidelines and six (6) protocols for control of medical devices and in-vitro diagnostics devices as described below:
    1. Guidelines on Good Review Practices for Regulation of Medical Devices, March, 2024;
    2. Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment, June, 2024;
    3. Guidelines for Conducting Performance Evaluation of In-Vitro Diagnostic Devices Submitted for Marketing Authorization, June, 2024;
    4. Protocol for Performance Laboratory Evaluation of Malaria Plasmodium Falciparum (PF) and MA PF/PAN Antigen Rapid Diagnostic Tests, First Edition, April, 2024;
    5. Protocol for Performance Laboratory Evaluation of Combined HIV and Syphilis Serology Assays, First Edition, April, 2024;
    6. Protocol for Performance Laboratory Evaluation of HIV Serology Assays, First Edition, April, 2024;
    7. Protocol for Performance Laboratory Evaluation of Hepatitis C Serology Assays, First Edition, April, 2024;
    8. Protocol for Laboratory Performance Evaluation of Hepatitis B Surface Antigen, First Edition April 2024;
    9. Protocol for Laboratory Performance Evaluation of SARS-CoV-2 Antigen Assays, First Edition April 2024;
  2. The new Guidelines and Protocols can be accessed through the TMDA website: www.tmda.go.tz.
  3. For further clarification on this notice, please do not hesitate to contact the Authority through e-mail: info@tmda.go.tz, or by phone and address below.
  4. We thank you for your continued cooperation.
Issued by:
Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
P.O. Box 1253 Dodoma
Telephone: +255 222 450512/658 445222/777 700002
Email Address: info@tmda.go.tz
Hotline: 0800110084