Medical Devices Rules, 2017
AI / PRIVACY / CYBER RELEVANCE
AI/ML software can be regulated when it falls within the medical-device definition and intended-use framework.
AI: HighPrivacy: HighCybersecurity: High
READ FIRST
- Rule 4 - classification
- First Schedule - risk parameters
- applicable licensing / quality-management provisions
PURVIEW
Provides the regulatory framework for medical devices in India, including classification, conformity assessment, licensing, quality systems, manufacture, import and post-market controls. For privacy, AI-enabled medical devices may process highly sensitive health information and therefore require strong security, controlled access, traceability and lawful data governance alongside medical-device compliance. The Rules are thus essential when an AI model becomes part of a regulated medical product rather than merely a general-purpose software tool.
Classification and legal status. Binding subordinate legislation.