Importation and Exportation of Medical Devices, 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 and Exporters:
- 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, Principal investigators and Researchers
- 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
- Importers & exporters must register their premises at TMDA before applying for permits (to register a premise)
- A person shall not import any device with shelf life of more than twenty-four months whose remaining shelf life is less than 60% or a device with shelf life of less or equal to twenty-four months whose remaining shelf life is less than 80%. (Where applicable)
- Compliance to conditions prescribed under section 1.4 of Guidelines for Importation and Exportation of Medical Devices Including In Vitro Diagnostics, Laboratory Equipment and Raw Materials
How to apply for an import or export permit?
- Create a trader portal account.
- Lodge an application online.
- Processing is within 7 days
Special Permit Procedure
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?
- Persons importing medical devices and Diagnostics for personal use;
- Hospitals importing medical devices, Diagnostics and laboratory equipment for hospital use;
- Institutions importing medical devices and Diagnostics for laboratory use and training purpose;
- Exhibitors and
- Importing wholesalers
How to apply?
Create a trader portal account.
Lodge an application online.
Processing is within 7 days
Conditions and documentation required for special permit are outlined in the Guidelines for Importation and Exportation of Medical Devices Including In Vitro Diagnostics, Laboratory Equipment and Raw Materials
Authorized ports of entry
All medical devices, including diagnostics, laboratory equipment, and raw materials imported into Tanzania, shall be allowed entry only through the following authorized Ports of Entry (PoEs). Click here to view the list of authorized Ports of Entry.