CDSCO Issues Regulatory Guidelines on Software and AI in Medical Devices

The Central Drugs Standard Control Organisation issued guidance on software and artificial intelligence use in medical devices to improve approval pathways.

Medical devices in India are regulated under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, using a four-tier risk classification.

While the guidelines bring clarity to software applications, experts note that India requires a clear statutory framework enacted as law for AI-MedTech.