TMDA REGISTRATION

TMDA is responsible for regulating safety, quality and effectiveness of medicines, medical devices and diagnostics. TMDA main responsibility is stated in the Health policy, 2007 and its mandate is stipulated in the Tanzania food, drugs and cosmetics act (TFDCA) cap. 219 as amended by the Finance Act of 2019.

The act provides for the efficient and comprehensive Regulation and control of safety and quality of medicines, medical devices and diagnostics in Tanzania mainland. In order to improve public service delivery, TMDA is managed as an Executive Agency in accordance with the Executive Agencies Act, cap.245 as amended in 2009.

We can help you with your TMDA registration. Tanzania Medicines and Medical Devices Authority (TMDA) is responsible for protecting and promoting public health by ensuring:

  • Quality, safety, and effectiveness of human and veterinary medicines, herbal medicines, medical devices and diagnostics.
  • It is charged on both locally produced goods and services and on imports.
  • Premises which are intended to be used for the manufacturer, storage and sale of TMDA regulated products should be registered by TMDA and issued with the PREMISES REGISTRATION CERTIFICATE.
  • After being manufactured/before being imported into the country, products which are regulated by TMDA should be registered and Issued with PRODUCT REGISTRATION CERTIFICATE so that they are authorized to be placed on the market.
  • All manufacturers and dealers of TMDA regulated products once their premises and products have been registered, they should be issued with TMDA BUSINESS PERMIT.

CATEGORIES OF TMDA REGULATED INVESTMENTS ARE THE MANUFACTURERS AND DEALERS OF:

  • Human and Veterinary medicines
  • Medical devices
  • Laboratory equipment
  • Diagnostics

WHO QUALIFIES:

Any person who is dealing with manufacturing, importation and distribution of Medicines, medical devices, laboratory equipment and diagnostics.