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Procedure for Marketing Authorization of Medical Devices and In-vitro Diagnostic Devices

Procedure for Marketing Authorization of Medical Devices and Diagnostics Devices

TMDA is mandate to authorize the marketing of medical devices (MD) and diagnostics devices (IVDDs) 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 IVDD. 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 Diagnostics 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.

Medical devices:

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

Diagnostics 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 diagnostics

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 diagnostics devices are also outlined under Part II and Part III of Compendium of Guidelines for Marketing Authorization of Medical Devices, Diagnostics and Laboratory Equipment, June, 2024 respectively.

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)
Step 1:
  • Classify your medical device or in-vitro diagnostic device; then
  • Confirm the procedure for authorization i.e., registration or notification
Step 2:
Step 3:
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;

Notification of Medical gases
What are medical gases?

Medical gases are gases utilized in hospitals and healthcare facilities as a key component in life supporting systems. These include gases used for anesthesia and life support. They are packed as compressed gas under pressure in cylinders or liquefied gas at high or low pressure and administered to patients through designated valves or evaporation and delivery by using hospital delivery systems.

Requirements for dealers of medical gases

All dealers/importers in medical devices gases need to be registered at TMDA.

Applications for business permits and premises registration can be made through the online Trader Portal. Processing of premises applications is done by TMDA Zone offices.

For detailed information about premises registration click here

How to apply for notification of medical gases
  • Register premises at TMDA
  • Lodge an application through the Trader Portal
  • Upload supporting documentation as follows:
    1. Name & physical form of the gas;
    2. Name of manufacturer (for imported gases);
    3. Pressure and//or concentration;
    4. Intended use of the gas; and
    5. Brief description of the container closure system

list of approved premises dealing with medical gases

list of local manufacturers approved to produce medical gases

list of approved medical gases