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Mobile Medical Apps

Official sources: CDSCO; ABDM — NHA; IMDRF

Overview​

Mobile medical applications (apps) are subject to CDSCO regulation when they are intended to diagnose, treat, monitor, or prevent disease, or affect the structure or function of the body.

Classification as Medical Device​

Not all health apps are medical devices. An app is regulated as a medical device when it:

  • Makes a medical claim (diagnosis, treatment, monitoring, prevention)
  • Provides medical advice or decision support
  • Processes or analyzes medical data for clinical purposes

Wellness apps without medical claims are generally not regulated.

Regulatory Pathway​

Mobile medical apps follow the SaMD regulatory framework under MDR 2017. Classification depends on risk and clinical context.

Submission Requirements​

  • Software documentation: Software design specification, testing protocols, validation reports
  • Clinical evidence: Literature review or clinical data supporting safety and effectiveness claims
  • Cybersecurity assessment: Data protection, user authentication, encryption measures
  • ABDM compliance: If connected to ABDM ecosystem, apps must meet interoperability standards