CDSCO implements new auto-generated MSC and NCC workflows
The Indian medical device industry is strictly regulated. Medical device manufacturers or importers are required to comply with regulatory guidelines as well secure the necessary certificates and licenses. The regulatory approval pathways for medical devices are being...
CDSCO License for Pulse Oximeters
Pulse oximeters are cheap, easy to carry, safe, and effective blood oxygen saturation level monitoring devices. Precise measurement of oxygen saturation and pulse rate is required, as treatment and diagnosis will depend on these findings. Substandard or low-quality...
Secure US FDA 510(k) Approval for IVDs in a Hassle-free Manner
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...