Procedure for Marketing Authorization of Medical Devices and In-vitro Diagnostic Devices
TMDA is mandate to authorize the marketing of medical devices (MD) and in-vitro diagnostic devices (IVDs) under Section 51 of the Tanzania Medicines and Medical Devices Act. The Authority has established two procedures for marketing authorizations depending on the risk associated with the MD or IVDs. According to The Tanzania Medicines and Medical devices (Control of Medical Devices) Regulations, 2015, all class A, B, C and D devices get market approval through registration while a selected class A devices attain market approval through notification.
Classification of Medical Devices and In-vitro Diagnostic Devices
Medical devices are classified according to the risks resulting from the use of the device, and in-vitro diagnostics according to the risk is associated with the implications of the results they produce either to the individual or public.
|Class||Risk Level||Device Examples|
|A||Low Risk||Surgical retractors / tongue depressors|
|B||Low-moderate Risk||Hypodermic Needles / suction equipment|
|C||Moderate-high Risk||Lung ventilator / bone fixation plate|
|D||High Risk||Heart valves / implantable defibrillator|
In-vitro diagnostic devices;
|Class||Risk Level||Device Examples|
|A||Low Individual Risk and Low Public Health Risk||Specimen Receptacles, prepared selective culture media|
|B||Moderate Individual Risk and/or Low Public Health Risk||Vitamin B12, Pregnancy self-testing,Anti-Nuclear Antibody, Urine test strips|
|C||High Individual Risk and/or Moderate Public Health Risk||Blood glucose self-testing, HLA typing,PSA screening, Rubella, Malaria|
|D||High Individual Risk and High Public Health Risk||HIV Blood donor screening, HIV Blood diagnostic|
Rules for classification are prescribed in the First Schedule of the Tanzania Medicines and Medical devices (Control of Medical Devices) Regulations, 2015. These rules are based on international practices and are in line with the rules of the Global Harmonization Task Force (GHTF). Classification rules for medical devices and In-vitro diagnostic devices are also outlined under Annex III of Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020 and Annex I of Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020.
Requirements for notification
- Description of the device including features, accessories, intended uses and users.
- 3D pictorial presentation of the device with all sides of the device clearly visible.
- Product label in line with Section four (4) of the guidelines and symbols according to ISO 15223-1.
- Evidence of Certificate of Compliance to ISO 13485 of the manufacturer(s).
- Certificate of analysis (if applicable) e.g masks, sanitary pads, diapers etc.
- Two (2) product samples in their commercial park.
How to apply for Market Authorization (Registration)
Post Registration Procedures
Validity of the registered product is five (5) years, after which it’s subject for renewal. For changes related to any registered medical devices and In-vitro diagnostic devices, the Market Authorization Holder must lodge a variation application.
Renewals and variations are applied through the online Trader Portal
Detailed information of requirements for registration, renewal and changes (variation) of the registered Medical Devices and In-vitro diagnostic devices they can be found in the Guidelines;
- Medical devices registration guideline: Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020.
- In-vitro diagnostics guidelines; Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020.