The Central Drugs Standard Control Organisation (CDSCO) has outlined the regulatory framework governing Artificial Intelligence (AI)-enabled medical devices in India, reaffirming that all such products are covered under the Medical Devices Rules (MDR), 2017. The Rules prescribe detailed technical documentation requirements for high‑risk medical devices, including those using AI.
Officials said applicants seeking approval for AI-based medical devices must submit comprehensive technical documentation demonstrating safety, performance and clinical effectiveness. This includes conformity with essential principles of safety and performance, verification and validation reports including software‑related assessments, risk analysis and mitigation plans, clinical evidence, quality management system documentation and software version release certificates when applicable.
Officials said applicants seeking approval for AI-based medical devices must submit comprehensive technical documentation demonstrating safety, performance and clinical effectiveness. This includes conformity with essential principles of safety and performance, verification and validation reports including software‑related assessments, risk analysis and mitigation plans, clinical evidence, quality management system documentation and software version release certificates when applicable.
The government noted that the timelines for granting manufacturing and import licences are clearly defined under Chapters IV and V of MDR‑2017.
Meanwhile, the Ministry of Health and Family Welfare has announced progress under the Secure AI in Health Initiative. The government launched the Strategy for AI in Healthcare in India (SAHI) and the Benchmarking Open Data Platform for Health AI (BODH) on 17 February 2026 at the India AI Impact Summit.
Meanwhile, the Ministry of Health and Family Welfare has announced progress under the Secure AI in Health Initiative. The government launched the Strategy for AI in Healthcare in India (SAHI) and the Benchmarking Open Data Platform for Health AI (BODH) on 17 February 2026 at the India AI Impact Summit.
SAHI serves as a national framework to guide safe, ethical and evidence‑based adoption of AI across the healthcare system. BODH, developed in partnership with IIT Kanpur, provides a structured mechanism for testing, validating and benchmarking AI systems before they are deployed on a large scale.
The Ministry added that the Ayushman Bharat Digital Mission (ABDM) continues to offer a sandbox environment and integration toolkits for health‑technology developers, enabling integration of applications—including AI‑driven screening tools—into the national digital health ecosystem. These steps, officials said, aim to ensure that emerging AI‑based healthcare technologies are introduced responsibly and in line with national standards.
The Ministry added that the Ayushman Bharat Digital Mission (ABDM) continues to offer a sandbox environment and integration toolkits for health‑technology developers, enabling integration of applications—including AI‑driven screening tools—into the national digital health ecosystem. These steps, officials said, aim to ensure that emerging AI‑based healthcare technologies are introduced responsibly and in line with national standards.
