Import and Export Control of Medical Devices

Importation and Exportation of Medical Devices and In-vitro Diagnostics including Laboratory Equipment pursuant to legal requirements prescribed under section 21(1)(d) of the TMDA Act, Cap 219.

The Authority grants importation of medical devices and In-vitro diagnostic devices which have been market approved through Registration or Notification ( For registration procedures Click here/ for Notification procedures Click here). Only approved dealers of medical devices and Invitro diagnostic devices are allowed to import or export medical devices in Tanzania (To be registered as a dealer of medical devices, diagnostic, laboratory equipment or medical gases Click here). Other groups for example, Independent people importing device(s) for personal use, Academic and Research Institutions, Government Institution, Non-Government Organization (NGO’s), Hospitals and Health Care services they are allowed to import or export medical devices and Invitro diagnostic devices under conditions which have been set by the Authority.

The importation and exportation permits have the validity of six (6) Month and it can be used to clear up to three (3) partial shipments.

Note: The application for importation should be submitted six weeks before shipment of the consignment from the country of departure.

Requirements for importers
  • All medical devices including laboratory equipment for human use to be imported must be registered by TMDA unless given special approval by the Authority.
  • All importation of medical devices including laboratory equipment must be done by importers whose premises are dully registered by TMDA
  • All importers must import medical devices including laboratory equipment through the authorized ports of entry (POE)

More requirements are outlined in the Guidelines for Importation and Exportation of Medical Devices including In-vitro Diagnostics and Laboratory Equipment, Second Edition, April 2020.

To apply for import or Export of medical devices and Invitro diagnostic devices Click here.

Requirements for importation of personal use products
  • A person importing any medical devices or In-vitro diagnostics devices for his personal use or the personal use of any member of his family subject to condition and quantity recommended by a registered medical practitioner, dentist or any other authorized practitioner and as the Authority deems fit. Should prepare and submit to TMDA the following documents:-
    1. Profoma invoice,
    2. Written recommendation for use of the device from a registered medical practitioner, dentist, or any other authorized practitioner. (applicable for devices in class B, C and D), or,
    3. Letter giving reasons for importation from applicant or qualified medical practitioner, dentist, or any other authorized practitioner.

For classification of devices, use rules for medical devices and In-vitro diagnostic devices are outlined under Annex I of Guidelines on Submission of Documentation for Registration of Medical Devices, third edition, April 2020 and Guidelines on submission of Documentation for Registration of In-vitro Diagnostic Devices, third edition, April 2020.

To apply for import or Export of medical devices and Invitro diagnostic devices click here.

More requirements are outlined in the Guidelines for Importation and Exportation of Medical Devices including In-vitro Diagnostics and Laboratory Equipment, Second Edition, April 2020.

Note: The application for importation should be submitted six weeks before shipment of the consignment from the country of departure.

Requirements for Importation of Donated Medical devices, Invitro diagnostics and Laboratory equipment:-

Any person, institution and organization intending to donate medical devices will be required to apply for import permit at TMDA Online portal.

Application should be accompanied by the following documents:

  1. A support letter from the relevant authority which supports such donation (where applicable).
  2. A support letter from the importer.
  3. Donation certificate.
  4. Declaration on Quality of donated product from Manufacturer/donor/certified Company.
  5. Proforma invoice.
  6. Certificate of analysis for sterile medical devices, in vitro diagnostics and laboratory equipment (Where applicable).
  7. Certificate of refurbishment for used medical devices (issued by manufacturer/donor of certified company).
  8. Certificates from relevant authorities for specific device such as Tanzania Atomic Energy Commission (TAEC).

To apply for import or Export of medical devices and Invitro diagnostic devices click here.

More requirements are outlined in the Guidelines for Importation and Exportation of Medical Devices including In-vitro Diagnostics and Laboratory Equipment, Second Edition, April 2020.

Note: The application for importation should be submitted six weeks before shipment of the consignment from the country of departure.

LIST OF AUTHORIZED POINTS OF ENTRIES FOR MEDICAL DEVICES AND INVITRO DIAGNOSTIC DEVICES

Importation of medical devices and in-vitro diagnostic devices is done through fifteen (15) designated official port of entries listed below: -

  • Dar-es-salaam International Airport,
  • Dar es salaam Sea Port,
  • Kilimanjaro International Airport,
  • Horohoro
  • Holili
  • Namanga
  • Sirari
  • Mwanza Lake Port,
  • Mwanza Airport,
  • Tanga Sea Port,
  • Tunduma
  • Mtukula
  • Rusumo
  • Kabanga
  • Kasumulo

Importation through any other port not listed above is not allowed.