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 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

The Medical Laboratory Science Council Advisory on COVID-19

The Medical Laboratory Science Council of Nigeria in line with its regulatory functions and mandate has viewed the emergence of the pathogen identified as Corona Virus (Covid-19) and other related pathogens with concern based on both the mode of transmission, the pathogenicity, the social and economic impact of the disease and hereby states as follows:

Due to the higher likelihood of the infection spread in crowded gathering, MLSCN is hereby suspending ALL Official activities (Inductions, Accreditations, Inspections, Meetings etc.) for a period of Six (6) Weeks with effect from 23rd March, 2020.

Individuals are advised to avoid handshakes, hugs, kisses, close contacts with other people. Use of alcohol-based hand sanitizers should be adhered to.

All Laboratory practitioners must wear appropriate Personal Protective Equipment (PPE) in the course of duty.

All good laboratory work practices and code of conduct should be practiced always.

Signed

Management


TEMPORARY SUSPENSION OF 200% PENALTY

The Governing Board of the Medical Laboratory Science council of Nigeria, as part of its efforts to join in the fight to curtail the spread of the Corona Virus (COVID-19) hereby temporarily suspends for a period of six (6) weeks in the first instance, the enforcement of the 200% penalty on late payment of Annual Practice licence with effect from April 1st, 2020.

Signed

Management