The WHO (2020) has stated that it has received multiple reports regarding falsified in vitro diagnostics and laboratory reagents for the detection of the virus, SARS-CoV-2.
The purpose of this pre-approval process is to prevent the importation of such falsified products.
All PCR and antigen test kit imports must apply for pre-approval via this form.
Reference: WHO. 2020. Medical Product Alert No3/2020 Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19. Ref RPQ/REG/ISF/Alert No3.2020.
Please note that by selecting "No" your submission will automatically be denied.