Company Registration
| Category | Amount (N) |
|---|---|
| Manufacturers/ Importers | 50,000.00 |
| Marketers | 30,000.00 |
| Annual Renewal of Registration | 5,000.00 |
Penalties
| Category | Penalty (N) |
|---|---|
| Manufacturing/ Importing without registration | 250,000.00 |
| Marketing of without registration | 150,000.00 |
Processing Fee (Per product)
| Service | Locally Produced IVD (N) | Imported IVD (N) |
|---|---|---|
| Product Listing Certificate (New Product) | ||
| All IVDs except equipment | TBD | TBD |
| Equipment | TBD | TBD |
| Method validation | TBD | TBD |
| Product Registration Certificate (Previously listed products) | ||
| Variants of listed product | TBD | TBD |
| Pack size alteration | TBD | TBD |
| Change of source | TBD | TBD |
| Change of design | TBD | TBD |
Penalties
| Category | Penalty (N) |
|---|---|
| Marketing of Unlisted IVDs (except equipment) | 500,000.00 |
| Marketing of unlisted Equipment | 750,000.00 |