The US FDA 510(k) approval process authorizes the marketing of IVDs in the US. Through this process the Food and Drug Administration (FDA) evaluates device safety and effectiveness before releasing it in the market. Hence, compliance with US FDA...
In this blog, we have presented the CDSCO regulations for invitro diagnostic devices in India. What are IVDs or In-Vitro Diagnostic Devices? In vitro diagnostics or IVDs are tests that are used to detect infections, diseases, and health conditions. The term ‘in vitro’...
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