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:

1. Description of the device including features, accessories and intended uses and users.
2. Pictorial three (3) Dimensional (3D) presentation of the device, whereas, all sides of the devices are clearly visible.
3. Product label; (should meet all labeling requirement for labelling of medical devices prescribed in Section four (4) of the guidelines and symbols according to ISO 15223-1.
4. Evidence of Certificate of Compliance to ISO 13485 of the manufacturer(s).
5. Certificate of Conformity to the device(s) to international standards.

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;-

1. Completely fill, sign and stamp Notification form for class A medical devices excepted from registration.
2. Two (2) product samples,
3. Notification required documents (described above).

To view list of notified medical devices, In-vitro diagnostic devices click here.

Guidelines;

• Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020
• Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020.

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;

• Applicant has to be registered as a Medical Gas Importer or Manufacturer of Medical Gases (as briefly described above),
• Fill and sign this application form according to Guidelines of Regulating Medical Gases, second edition, April 2020 and submit to TMDA along with document(s) with following information;
  1. Name of the gas followed by medical,
  2. Physical form of the product,
  3. Name of manufacturer (for imported gases),
  4. Pressure and/or concentration,
  5. Intended use of the gas, and
  6. Brief description of the containers

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.