Procedures for Notification
Notification of Medical Devices, In-vitro Diagnostic Devices and Laboratory Equipment
Notification is the Market Authorization procedure for low risk medical devices and In-vitro diagnostic devices. All class A Medical devices and In-vitro diagnostic devices which are either non-sterile, not active or without measuring functions and all laboratory apparatus are considered to be low risk devices and they are exempted from TMDA registration procedures, however, they get approved through notification.
Some examples of class A medical devices exempted from registration are listed in the second schedule of the Tanzania Medicines and Medical Devices (Control of Medical devices) Regulations, 2015. Note that, the list provides limited examples, the classification rule in the first schedule should be used in classification of both medical devices and In-vitro diagnostic devices.
Requirements for Notification
An application for Notification should be accompanied with the following documents:
To apply online for Notification of Class A medical Devices or Invitro diagnostics devices exempted from registration click here.
For offline option submit to TMDA office the following;-
To view list of notified medical devices, In-vitro diagnostic devices click here.
Notification of Medical gases
Medical gases have been in use for decades in hospital and home settings as key components of life supporting systems in human beings. 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. These product get market authorization through the procedure of Notification.
For imported medical gases, the Importer has to be registered by TMDA as a dealer of medical gases. To apply for business permit and premises registration to deal with Medical gases the interested applicant has to be registered in the respective zones where the premises is located. To view TMDA Zone offices please visit the main menu.
To apply for online business permit and Premises registration Certificate click here.
For more details information about premises registration click here.
To apply for notification of medical gases;
To view list of approved premises dealing with medical gases click here.
To view list of local manufacturer approved to produce medical gases click here.
To view list of approved medical gases click here.