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.

 

Do you have what it takes to be the next ISN Medical Lab Scientist of the Year?

Dear Colleagues, Application for 2021 ISN Medical Laboratory Scientists of the year is open. The Management of MLSCN urges Colleagues to participate and showcase their talents. Please apply via https://isnmedical.com/imlsoty/