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...
Revised Risk-Based Classification List for Cardiovascular & Neurological Medical Devices
Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for medical devices, drugs, and cosmetics in India. The CDSCO works under the guidance of Medical Devices Rules (MDR), 2017. The Drug Controller General of India (DCGI) is the governing...