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Regulatory strategy

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.