Fees and Charges for Medical Devices Premises Licensing and Compliance

Fees and Charges for Medical Devices Premises Licensing and Compliance

The fees and charges outlined below are as per The Tanzania Medicines and Medical Devices (Fees and Charges) Regulation, GN No. 686, 2021

S/N SERVICE FEES
1 QUALITY AUDIT
Quality Audit fee for and medical device facilities per block (Foreign)
East Africa 4,000 USD
Southern Africa Development Community (SADC) Countries 4,500 USD
Rest of Africa 5,000 USD
Asia 6000 USD
Europe 6500 USD
America 7500 USD
Australia and New Zealand 7500 USD
2 PREMISES
Large Medical Devices, Diagnostics and Medical Gases Manufacturers TZS 700,000
Medium Medical Devices, Diagnostics and Medical Gases Manufacturers TZS 500,000
Small Medical Devices, Diagnostics and Medical Gases Manufacturers TZS 300,000
Wholesale Medical Device Outlets TZS 300,000
Medical Device and Diagnostic Warehouses TZS 300,000
Retail Medical Device Outlets TZS 100,000
Disposal charge on value of condemned products TZS 25%
3 IMPORTATION FEES
Medical Devices, Diagnostics and Medical laboratory equipment 2% FoB
Donated Medical Devices, Diagnostics Medical Laboratory Equipment 0.25% FoB
Accessories and spare parts for Medical Devices, Diagnostics and Medical Laboratory Equipment 0.5% FoB