IVD Applicable Fees

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