Procedure for Product Marketing Authorization
Procedure for Product Market Authorization
Tanzania Medicines and Medical Devices Authority (TMDA) grants Market Authorization of Medical Devices and Diagnostics, according to Section 51 of the TMDA Act, Cap 2019 after assessing product’s technical information, inspecting the respective manufacturing facility and performance evaluation for the case of Invitro diagnostic devices (IVDS).
According to TMDA Control of Medical Devices Regulations download here, all Class A, B, C, and D Medical Devices and Invitro Diagnostic Devices get market approval through Registration, or Notification for selected class A. The classification of medical devices and Invitro diagnostics devices is done according to TMDA Medical Devices Regulations which is also in line with Global Harmonization Task Force (GHTF) classification rules of the concerned product. Medical devices are classified depending on the risk and possible harm to they might cause to the user of devices. Class
A medical devices are considered to be low risk devices, and Class D are high risk devices.
Invitro diagnostic devices since they don’t come in contact with the patient and they achieve their functions by detecting 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 that give test results of a diseases which have low personal risk and low public risk of propagation of those diseases are in Class A, while the ones which detect the presence of infection of a diseases which have high personal and public health risks are in Class D.
Classification rules of medical devices and Invitro diagnostic devices are stipulated under Annex I of Medical Devices Registration Guidelines(Click here and Invitro Diagnostic Guidelines(click here).
To apply for registration of medical devices or Invitro diagnostic devices you are required to do the following:-
a)Fill completely, stamp and sign medical devices application form, and for Invitro diagnostic application form. (click here)
b)Compile technical information (dossier) according to guidance given under Medical devices registration guidelines and Invitro diagnostic guidelines
c)Prepare two (2) soft copies and one (1) hard copy of all information, and submit to TMDA.
d)To apply for registration online click here
e)Submit two (2) product samples to TMDA.
Validity of the registered product is five (5) years, after which it’s subject for renewal.