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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 should be registered by the Authority.

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

Premise Registration & Licensing Requirements

The application for premise registration and licensing should be accompanied by the following;

  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 The Tanzania Medicines and Medical Devices (Good Storage and Distribution Practices) Regulations, 2021

Registration and Licensing Requirements for Domestic Manufacturers

Requirements for registration and licensing of 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

List of Manufacturing facilities

Registration and Licensing Process for Domestic Manufacturers / Premise

All applications are processed at TMDA Zone offices. The following processes are involved:

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

Business permit issued shall expire on 30th June every year, after which renewal of business permit is required.