Company Registration
| Category |
Amount (N) |
| Manufacturers/ Importers |
250,000.00 |
| Marketers |
150,000.00 |
| Annual Renewal of Registration |
30,000.00 |
Penalties
| Category |
Penalty (N) |
| Manufacturing/ Importing without registration |
500,000.00 |
| Marketing of without registration |
300,000.00 |
Cost of Validation (New Product)
| Service |
Locally Produced IVD (N) |
Imported IVD (N) |
| Class 1 IVD Products |
3.5 Million |
5 Million |
| Class 2 IVD Products |
8.5 Million |
11 Million |
| Class 3 IVD Products |
17 Million |
21 Million |
| Validation of IVD Equipment and Systems |
18.5 Million |
22 Million |
Cost of Validation (Previously Listed Product)
| Service |
Locally Produced IVD (N) |
Imported IVD (N) |
| List updating |
500,000 |
1 Million |
| Re-labelling/ Re-packaging fee |
10% of validation fee to cover the verification |
10% of validation fee to cover the verification |
Penalties
| Category |
Penalty (N) |
| Marketing of Unlisted IVDs (except equipment) |
5 Million |
| Marketing of unlisted Equipment |
5.5 Million |
| Re-packaging/ Re-labelling |
5.5 Million |
* Terms and conditions apply
**These prices are subject to review without notice based on individual product/analyte peculiarity.
***Individual invoices shall be issued to each vendor from the IVD Lab.
