Parliament Question: AI-Based Medical Devices and Software

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARRED QUESTION NO. †1034 TO BE ANSWERED ON24THJULY, 2026 AI-BASED MEDICALDEVICES AND SOFTWARE †1034.DR. SAMBITPATRA:

Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:

(a) whether the use of AI-based medical devices and software is increasing in the country, if so, the detailsthereof;

(b) whether the use of AI-based software for cancer screening and diagnosis is increasing in the country, if so, the details thereof along with the steps taken/proposed to be taken by the Government toregulate such software;

(c)the steps taken/proposed tobe taken bythe Government toensure patientsafety inviewof the increasing use of AI-based medical software, if so, the detailsthereof; and

(d) the safeguards implemented by the Government to ensure the security of patient data in viewof the increasing use of AI-based medical software? ANSWER THE MINISTER OFHEALTH AND FAMILYWELFARE (SHRIJAGATPRAKASH NADDA)

(a)to(d): All medical devices, including the software intended to be used for medical purposes (Medical Device Software) are regulated under the provisions of Medical Devices Rules, 2017.

In respect of AI-enabledmedical devicesandsoftware, the applicant isrequiredto submit comprehensive technical documentation in accordance with the said rules. The key technical

documentationrequirements include:

(i). Essential Principle Checklist to demonstrate conformity with applicable safety and performance requirements;

(ii). Verificationand validationdocumentationincludingsoftware;

(iii). Risk analysis andcontrol documents;

(iv). Clinicalevidence insupport of safety,performance andeffectiveness;

(v). QualityManagement System documents;

(vi). Software version release certificatesif any;

(vii). Post Marketing Surveillance documentationincluding anysuspected unexpected serious adverse event, recall, Periodic Safety Update Report (PSUR) are monitored by theCDSCO asperprovisions mentionedin ChapterIV, V,VII, VIII, XI of Medical Devices Rules2017.

CDSCO hasdevelopedandpublished variousguidance documents, classification lists, and Frequently Asked Questions (FAQs) to provide clarity on the requirements under the Medical DevicesRules, 2017.

The Ministry of Health and Family Welfare has launched the ‘Strategy for AI in Healthcare in India’ (SAHI) and the ‘Benchmarking Open Data Platform for Health AI’

(BODH) on 17th February 2026 during the India AI impact summit. SAHI is a national guidance framework to enable the safe, ethical, evidence-based, responsible and inclusive adoptionof artificial intelligenceacross India’shealthcaresystem. ‘BenchmarkingOpen Data Platform for Health AI’ (BODH) provides a structured mechanism for testing and benchmarking AI solutions before deployment at scale. SAHI has been developed after intensive consultation with all the major stakeholders of the healthcare ecosystem, including acedemia.

Ayushman Bharat Digital Mission (ABDM) provides a sandbox environment and integration toolkits that allow health technology developers to integrate their applications/ software, includingAI screening tools.

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