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
