TMDA REGISTRATION

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:

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

It is charged on both locally produced goods and services and on imports.
Quality, safety, and effectiveness of human and veterinary medicines, herbal medicines, medical devices and diagnostics.
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.

WHO QUALIFIES:

Human and Veterinary medicines
Medical devices
Laboratory equipment
Diagnostics

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

Need Any Help

Need Any Help, Call Us 24/7 For Support

Call Us
+255 763 666 993
Mail Us
info@tanbizlink.co.tz
Office Address
Sea Cliff Village - 10 Toure Drive, Masaki Dar es Salaam - Tanzania.

Start Your Project?

Mauris ut enim sit amet lacus ornare ullamcorper. Praesent placerat neque eu.