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, 2022
| SN | SERVICE | FEES | PROCESSING TIME |
|---|---|---|---|
| 1 | QUALITY AUDIT | ||
| Quality Audit fee for and medical device facilities per block (Foreign) | |||
| East Africa | 4,000 USD | Within 50 working days | |
| 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 | Within 8 working days | |
| Medium Medical Devices, Diagnostics and Medical Gases Manufacturers | TZS 500,000 | Within 8 working days | |
| Small Medical Devices, Diagnostics and Medical Gases Manufacturers | TZS 300,000 | Within 8 working days | |
| Wholesale Medical Device Outlets | TZS 300,000 | Within 7 working days | |
| Medical Device and Diagnostic Warehouses | TZS 300,000 | Within 7 working days | |
| Retail Medical Device Outlets | TZS 100,000 | Within 7 working days | |
| Disposal charge on value of condemned products | TZS 25% | ||
| 3 | IMPORTATION FEES | ||
| Medical Devices, Diagnostics and Medical laboratory equipment | 2% FoB | Normal within working 24hrs Special importation within seven (7) working days | |
| Donated Medical Devices, Diagnostics Medical Laboratory Equipment | 0.25% FoB | Within seven (7) working days | |
| Accessories and spare parts for Medical Devices, Diagnostics and Medical Laboratory Equipment | 0.5% FoB | Within seven(7) working days | |