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.