The Central Drugs Standard Control Organisation (CDSCO), functioning under the Directorate General of Health Services, Ministry of Health and Family Welfare, has issued a circular notifying the final Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD/MDSW/01/2026).
The move follows India’s 2020 gazette notification bringing all medical devices, including software used for medical purposes, under regulation via the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017. A draft version had been circulated in October 2025 inviting public feedback, which was subsequently reviewed with expert stakeholders before finalisation.
The new guidance is designed to bring India’s regulatory submission process in line with international norms. It lays out the classification framework, applicable safety and performance benchmarks, documentation expectations, quality management requirements, and post-market compliance obligations for software-based medical devices.
The circular, signed by Drugs Controller General (India) Dr.Rajeev Singh Raghuvanshi, has been circulated to all State and Union Territory licensing authorities and made available to stakeholders via the CDSCO website.
Written By: Sayan Das
Graphics by: Pramit Hazra
