IVDs Approved 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 20,000.00 50,000.00
Equipment 100,000.00 250,000.00
Method validation 50,000.00 150,000.00
Product Registration Certificate (Previously listed products)
Variants of listed product 20,000.00 50,000.00
Pack size alteration 10,000.00 30,000.00
Change of source 30,000.00 150,000.00
Change of design 10,000.00 30,000.00

Penalties

Category Penalty (N)
Marketing of Unlisted IVDs (except equipment) 500,000.00
Marketing of unlisted Equipment 750,000.00