REGISTERING AN IVD PRODUCT (REAGENTS, RDTS, CONSUMMABLES): (REQUIREMENTS FOR PRODUCT LISTING)
The following are required for IVDs Product Listing:
- Evidence of company registration from the IVDs Laboratory
- Application for Product Listing
- Submit a photocopy of your Trade Mark Registration Certificate as applicable
- Submit a photocopy of a Memorandum of understanding (MOU) or Letter of Authorization as a Distributor as applicable
- Application for provisional import permit (if required);
- 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).
- 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.