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

You are to submit 300 worth of test kits for the validation exercise and pay validation fees of Three Million Naira (N3,000,000.00) only, via the Remita platform on our website: www.mlscn.gov.ng.
To make payment, select ‘Public Medical Laboratory’ and describe payment as ‘Payment for Covid 19 Validation’.
For company registration, please fill the attached form for each company and attach all necessary documents with the relevant payment.
We will be glad to provide any further support to you and your team in the fight against this pandemic.

Below are applicable documentation for your use in the requesting of validation for your COVID-19 IVDs.

For further clarifications/ Enquiries, please contact us via email – poffutalu@mlscn.gov.ng

It has come to the attention of the Medical Laboratory Science Council of Nigeria that some individuals posing as staff of Council have adopted for use fake Council email addresses and fake letterheads (which may be close to but different from the original) to put forward request for invitations to various international conferences. The ultimate aim of these individuals is to secure unmerited visas with which to travel out of Nigeria even if it means denting the hard earned reputation of Council.

The Medical Laboratory Science Council of Nigeria hereby notifies the public particularly the international community that these individuals are not bonafide staff of the Council and all such requests are fake and do not originate from Council. Any person who has any inquiry to make about such requests should contact Council via its authentic email address – info@mlscn.gov.ng

Anyone who carries out any transaction with any of these imposters and fraudsters does so at his/her own risk. BE WARNED!

File	DLs
Guidelines on Setting up a Medical Laboratory	7963
Guidelines on Staffing Requirements of MLS Practitioners	3932
50th Anniversary Special Edition Bulletin	3620
MLSCN Quality Manual	3558
Regulation for Minimum Practice Standards 2018	3279