Importation and Exportation of Medical Devices, Invitro Diagnostic Devices and Laboratory Equipment

Section 73 of the Tanzania Medicines and Medical Devices Act, Cap 219. gives mandate to TMDA to regulate importation and exportation of medicines, medical devices, invitro diagnostics and biocidals


Categories of importers: Government & Non-Government Institutions
  • Wholesalers: medical devices, in-vitro diagnostics, laboratory equipment
  • Manufacturers: medical devices, in-vitro diagnostics, medical gases and laboratory equipment
  • Clinical trial sponsors and Principal investigators
  • Recipients of donations

When to apply for an import or export permit?
  • At least 6 weeks prior to shipment of the consignment:
    • Avoid storage costs at Ports of Entry (PoE)
    • Avoid disposal costs of unpermitted products

Requirements

How to apply for an import or export permit?
Special Permit Procedure
What is it?
special permit is an importation permit issued under section 57 (1) of the Act to allow importation of an unregistered regulated products for public interest
Who can apply?

Hospitals

Healthcare providers

Clinical trial personnel

General public (Personal use)

How to apply?

Create a trader portal account.

Lodge an application online.

Processing is within 7 days

Online Trader Portal User Manual