India Risk Classification for Neurology as Medical Device
Introduction: Neurology Products as Medical Device Classification in India This article focuses on the classification of Neurology Products. The Central Drugs Standard Control Organization (CDSCO) has established risk-based classification lists to ensure these devices meet international safety and efficacy standards. This classification helps manufacturers understand the risk level and intended use of their devices. The […]
India Risk Classification for Respiratory Equipment as a Medical Device
Introduction: Respiratory Equipment Classification in India Respiratory medical devices play an important role in diagnosis, monitoring, and treatment of respiratory conditions. Under the Medical Device Rules 2017 in India, respiratory equipment is classified based on risk levels in accordance with medical device registration in India. The Central Drugs Standard Control Organization (CDSCO) continues to update […]
India Risk Classification for General Hospital As Medical Device
The table below provides the updated classifications for General Hospital Products. Devices reclassified to Class A (Non-Notified) have been highlighted in dark grey for better identification. This detailed breakdown helps manufacturers and stakeholders navigate the medical device registration in India effectively. Table: General Hospital As Medical Device India S.No. Device Name Intended Use Risk Class […]
India Risk Classification for Urology as a Medical Device
Introduction: Urology Equipment Classification in India Urology medical devices are essential for the diagnosis, treatment, and management of urological conditions. These devices have been classified under the Medical Device Rules 2017 in India, ensuring they meet safety and regulatory compliance standards. The Central Drugs Standard Control Organization (CDSCO) categorizes Urology Products classification in India into […]