The Ministry of Health and Family Welfare (MoH&FW), on March 10, 2026, notified regarding the Update on Secure AI in Health Initiative.
The following has been stated namely:-
• In respect of AI-enabled medical devices, the applicant is required to submit comprehensive technical documentation in accordance with the said rules. The key technical documentation requirements include:
• Essential Principles Checklist to demonstrate conformity with applicable safety and performance requirements;
• Verification and validation documentation including software;
• Risk analysis and control documents;
• Clinical evidence in support of safety, performance and effectiveness;
• Quality Management System documents
• Software version release certificates if any.
[Press Release ID: 2237406]
