Most of the current malaria RDTs on the market are
highly required to pass the testing programme that are developed by
WHO and Foundation for Innovative New Diagnostics (FIND), which is
called WHO-FIND malaria RDT evaluation programme. Passing this
programme will give our device a great pass and become credible to
potential customers. Prior to entering this programme, we will need to
acquire ISO 13485:2003 certification. For FDA, our device is listed as
an in vitro diagnostic product (IVD) and classified as class II
device, which mean it will need general controls and special controls.
Therefore, we will need to submit the
510(k) Premarket Notification to
obtain market clearance as required by FDA.