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

Accreditation & Re-accreditation of Medical Laboratories by MLSCN Accreditation Service

This is to inform the General Public that 661 Nigerian Air Force Hospital Laboratory, Ikeja, Lagos State and EL Lab Laboratories, Festac, Lagos State have been re-accredited by the MLSCN Accreditation Service.

Furthermore, Total Healthcare Diagnostics, Bodija, Ibadan, Oyo State has also been accredited by The MLSCN Accreditation Service. The List of Accredited Laboratories is available at the MLSCN accreditation Service Website via the link (http://mlscn-as.org/accredited.html)

Signed

MANAGEMENT