Frequently Asked Questions

Tanzania Medicines and Medical Devices Authority (TMDA) is a semi-autonomous regulatory body under the Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC); which is responsible for protecting and promoting public health by ensuring safety, quality and effectiveness of medicines, medical devices and diagnostics. It was established under the Tanzania Medicines and Medical Devices Act, Cap 219.

TMDA, formerly known as TFDA became operational on 1st July, 2003. However, the name TFDA was statutorily changed into TMDA on 1st July, 2019 after the amendment of the Tanzania Food, Drugs and Cosmetics Act, Cap 219 by the Finance Act No. 8 of 2019. This resulted into parting in the regulation of medicinal products from that of food products. In view of this, TMDA is currently mandated to regulate three (3) types of products namely: medicines, medical devices and diagnostics whereas TFDA by then, was mandated to regulate five (5) types of products namely: food, medicines, cosmetics, medical devices and diagnostics.

TMDA became operational with effect from 1st July, 2019 following the amendment of the Tanzania Food, Drugs and Cosmetics Act, Cap 219; whereby the regulation of two (2) types of products i.e. food and cosmetics were shifted from the then Tanzania Food and Drugs Authority (TFDA) to Tanzania Bureau of Standards (TBS).

TMDA is a regulatory body under the Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC) responsible for protecting and promoting public health by ensuring quality, safety and effectiveness of medicines, medical devices and diagnostics. It was established under the Tanzania Medicines and Medical Devices Act, Cap 219.

On the other hand, TBS is a parastatal organization under the Ministry of Industry and Trade and its broad mandate is to promote standardization and quality assurance in industry and commerce sectors.

TMDA regulates human and veterinary medicines (which include herbal and biocidal products), medical devices and diagnostics.

No, TMDA does not regulate traditional medicines. Such medicines are regulated by Traditional and Alternative Heath Practice Council click here for more details.

Yes, hand sanitizers are considered as antiseptics which are categorized as medicinal products and therefore regulated by TMDA. For more information about regulation of hand sanitizers click here for more details.

Yes, masks and other PPEs are classified as medical device products, thus their regulation is under TMDA click here for more details.

To register masks, PPEs and hand sanitizers, you are required to fill an application form and submit the documents to TMDA along with the product samples click here for more details.

Masks are considered to be low risk products and hence categorized as Class A medical devices; there are no known side effects ever been reported and/or associated with the use of masks that could be injurious to health. Furthermore, manufacturers of masks provide instructions which specify the conditions and duration for the use of masks. If used appropriately and in line with manufacturer’s instructions, masks have a great role in prevention of airborne diseases.