Registration and licensing of premises

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 has been registered by TMDA. Premises dealing with whole sale business of medical devices, in-vitro diagnostic devices and laboratory equipment have to be registered by the Authority. Application of premises registration can be submitted to TMDA Zone offices. For information on TMDA Zone offices, click here.

An application package should consist of the following documents: -

  1. Completely filled, signed and stamped application form for registration of premises and business permit.
  2. Copy of Taxpayer Identification Number (TIN) issued by TRA.
  3. Copy of certificate of superintendent from any medical field (certificate level/diploma/advance diploma etc).
  4. Commitment letter from superintendent or signed contract (if applicable).
  5. A copy of certificate of Registration from the Business Registration and Licensing Agency (BRELA),
  6. Premises Layout/ Sketch
  7. A copy of Memorandum and Articles of Association

To apply online for premises registration click here.

For detailed information regarding business registration and licensing refer to the Guidelines for Business Licensing and Good Storage and Distribution Practices of Medicines, and Medical Devices.

For the business permit and premises registration of domestic manufacturer of medical devices, in-vitro diagnostic devices or laboratory equipment, apply directly to TMDA sub office in Dar es Salaam. The application should be accompanied by the following documents: -

  1. Completely filled, signed and stamped application form for registration of premises and business permit.
  2. A copy of Certificate of Incentives from the Tanzania Investment Centre (TIC),
  3. A copy of Memorandum and Articles of Association,
  4. An approval from the National Environment Management Council (NEMC) on suitability of a site/plot for medical devices manufacturing activities.
  5. Facility layout

To apply online for manufacturing license click here.