Medical Devices Assessment Fees and Charges
Fees and Charges for Market Authorization of Medical Devices and In-Vitro Diagnostic Devices
The fees and charges outlined below are as per The Tanzania Medicines and Medical Devices (Fees and Charges) Regulation, 2022
| Medical Devices - Fees & Charges and Processing timelines | ||||
|---|---|---|---|---|
| Domestic Devices | Imported Devices | |||
| Process | Fees in TZS | Processing time (in days) | Fees in USD | Processing time (in days) |
| Notification | 50,000 | 5 | 100 | 5 |
| Registration class A | 100,000 | 20 | 500 | 45 |
| Registration class B | 200,000 | 20 | 2500 | 45 |
| Registration class C, D | 500,000 | 45 | 2500 | 45 |
| Major variation | 150,000 | 10 | 300 | 10 |
| Minor variation | 100,000 | 10 | 150 | 10 |
| Retention - registered devices | NA | 200 | ||
| Retention - notified devices | NA | 50 | ||
| Invitro Diagnostic Devices - Fees & Charges and Processing timelines | ||||
|---|---|---|---|---|
| Domestic Devices | Imported Devices | |||
| Process | Fees in TZS | Processing time (in days) | Fees in USD | Processing time (in days) |
| Notification | 50,000 | 5 | 100 | 5 |
| Registration class A | 100,000 | 20 | 300 | 45 |
| Registration class B | 200,000 | 20 | 1000 | 45 |
| Registration class C | 500,000 | 45 | 1500 | 45 |
| Registration class D | 500,000 | 10 | 2000 | 10 |
| Major variation | 150,000 | 10 | 500 | 10 |
| Minor variation | 100,000 | 10 | 200 | 10 |
| Retention - registered devices | NA | 200 | ||
| Retention - notified devices | NA | 50 | ||