Registration and licensing of premises

Types of Premises that Require Registration and Business Licenses

Section 18 of the Tanzania Medicines and Medical Devices Act, Cap 219. restricts the manufacture for sale, sell, supply or storage of medical devices, in-vitro diagnostic devices and laboratory equipment unless the premises have been registered by TMDA.

Premises dealing with whole sale business of medical devices, in-vitro diagnostic devices, laboratory equipment and medical gases have to be registered by the Authority.

Domestic manufacturing facilities also need to be registered by the Authority.

Premise Registration & Licensing Requirements
  1. Copy of Certificate of Registration from Business Registration and Licencing Authority (BRELA).
  2. Tax Payer Identification Number (TIN).
  3. A copy of a contract with superintendent/in charge of the business.
  4. A copy of registration certificate of the superintendent issued by the respective councils or professional boards.
  5. Premise layout/sketch.
  6. Copy of Memorandum and articles of Association.

For detailed requirements, please refer to the Guidelines for Business Licensing and Good Storage and Distribution Practices of Medicines, and Medical Devices

Registration and Licensing Requirements for Domestic Manufacturers
  1. A copy of Certificate of Incentives from the Tanzania Investment Centre (TIC)
  2. An approval from the National Environmental Management Council (NEMC) on suitability of the site/plot for medical devices manufacturing activities
  3. Facility layout
  4. Copy of Certificate of Registration from Business Registration and Licensing Authority (BRELA).
  5. Tax Payer Identification Number (TIN). .
  6. A copy of a contract with superintendent/in charge of the business.
  7. A copy of registration certificate of the superintendent issued by the respective councils or professional boards.
  8. Premise layout/sketch
  9. Copy of Memorandum and articles of Association
Registration and Licensing Process for Domestic Manufacturers / Premise

Applications are processed at TMDA Zone offices except for manufacturing facilities which are processed at TMDA sub office in Dar es Salaam

  1. Lodge and application online through the Trader Portal;
  2. Make necessary payment as per Fees & Charges Regulation;
  3. TMDA inspection of the premise as per Inspection Checklist; then
  4. Premise registration & issuance of business permits for compliant premise.

Business permits expire on 30th June of each year, after which renewal of business permit is required.