Registering an IVD Product

REGISTERING AN IVD PRODUCT (REAGENTS, RDTS, CONSUMMABLES): (REQUIREMENTS FOR PRODUCT LISTING)

The following are required for IVDs Product Listing:

  1. Evidence of company registration from the IVDs Laboratory
  2. Application for Product Listing
  3. Submit a photocopy of your Trade Mark Registration Certificate as applicable
  4. Submit a photocopy of a Memorandum of understanding (MOU) or Letter of Authorization as a Distributor as applicable
  5. Application for provisional import permit (if required);
  6. Submission of the required quantity of IVDs products for evaluation with company listing file document (refer to mlscn.gov.ng submenu IVDs regulation, submenu product listing file).
  7. Submit evidence of payment for Product Listing to MLSCN TSA account via Remita platform

REQUIREMENT/PROCESS FOR EQUIPMENT LISTING WITH IVDS LAB.

The following are required for Equipment Listing:

  • Equipment presentation, installation and trial runs by the Distributor/Manufacturer’s Field Service Engineer;
  • Presentation of payment evidence of N250,000 for product evaluation and listing;
  • Equipment evaluation;
  • Equipment collection from IVDs Laboratory by the distributor/manufacturer;
  • Issuance of product listing certificate by IVDs Lab.

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