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
- Importers & exporters must register their premises at TMDA before applying for permits (to register a premise)
- Compliance to conditions prescribed under section 2.3 of Guidelines for Importation and Exportation of Medical Devices including Invitro Diagnostic Device and Laboratory Equipment
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?
- Healthcare providers
- Clinical researchers
- General public (Personal use)
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 Invitro Diagnostic Device and Laboratory Equipment