Procedures for Market Authorization
TMDA grants Market Authorization of Medical Devices and In-vitro Diagnostic Devices, according to Section 51 of the Act after assessing product technical information, inspection of manufacturing facility and performance evaluation of Invitro diagnostic devices (IVDS). According to The Tanzania Medicines and Medical devices (Control of Medical Devices) Regulations, 2015 – GN ( download here), all Class A, B, C, and D Medical Devices and In-vitro Diagnostic Devices get market approval through Registration, and Notification for selected class A.
The classification of medical devices and In-vitro diagnostics devices is done according to rules for classification prescribed in the First Schedule of the Tanzania Medicines and Medical Devices (Control of Medical devices) Regulations, 2015 which are also in line with Global Harmonization Task Force (GHTF) rules of classification of medical devices and diagnostic devices.
Medical devices are classified according to the risks and possible harms to the user that could be associated with the use of devices. Class A medical devices are considered to be low risk devices, class B are Low to Moderate risk devices, class C Moderate to High risk devices, and class D are high risk devices.
In-vitro diagnostic devices since they don’t come in contact with the patient, they achieve their functions by only detect the presence of infection from the sample which have corrected from human or animal, their main risk once used is the implications of the results they produce. Diagnostic devices which give test results of a disease which has no personal risk and low public risk of propagation are in class A, class B have Low public health risk or moderate personal risk, class C have Moderate public health risk or high personal risk while the ones which detect the presence of infection of a disease which has high personal and public health risks are in class D.
Classification rules for medical devices and In-vitro diagnostic devices are also outlined under Annex I of Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020 and Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020.
To apply for registration of medical devices or Invitro diagnostic devices in Tanzania you are required to do the following:-
- Fill completely, stamp and sign medical devices application form, and for Invitro diagnostic use this application form.
- Compile technical information (dossier) according to guidance given under Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020, and Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020
- c) Prepare electronic copies of of all information, and submit to TMDA via online application portal.
- Submit two (2) product samples to TMDA.
- To apply for registration online click here.
Validity of the registered product is five (5) years, after which it’s subject for renewal. To apply for renewal fill this application form and submit to TMDA along with dossier and samples.
For changes (variations) related to any registered medical devices and In-vitro diagnostic devices fill this application form and submit to TMDA along with information related to changes (variations) and product sample (if applicable).
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.