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SaMD & Standalone Software Classification

Definition​

Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes, and that performs these purposes without being part of a hardware medical device.

Examples include:

  • AI-based diagnostic imaging analysis software (e.g., pneumonia detection from chest X-rays)
  • Clinical decision support tools with direct clinical impact (e.g., risk stratification algorithms)
  • Remote patient monitoring software with therapeutic functions (e.g., insulin dosing recommendations)
  • Symptom checker and triage algorithms
  • Digital therapeutics (e.g., cognitive behavioural therapy applications)

IMDRF SaMD classification framework​

India has aligned with the IMDRF SaMD Classification framework (N12FINAL). Classification is based on two factors:

  1. State of the healthcare situation — critical, serious, or non-serious;
  2. Significance of SaMD information to a healthcare decision — treat/diagnose, drive clinical management, or inform clinical management.

This produces a risk score of I (lowest) to IV (highest), which maps to India's Class A–D classification.

Regulatory pathway​

Higher-risk SaMD (Classes C and D) requires CDSCO import licence (Form MD-14) or CDSCO manufacturing licence, with clinical evaluation evidence of the software's performance.

CDSCO is developing specific SaMD guidance aligned with the IMDRF framework. See Digital Health & SaMD for current status.

Add the following section after the 'IMDRF SaMD classification framework' paragraph:

Risk Score to Class Mapping

The IMDRF risk scores translate to India's medical device classes as follows:

  • Risk Score I → Class A: Lowest risk SaMD, self-assessment permitted
  • Risk Score II → Class B: Low-to-moderate risk, may require clinical evaluation or reference approval
  • Risk Score III → Class C: Moderate-to-high risk, typically requires clinical data and CDSCO import or manufacturing licence
  • Risk Score IV → Class D: Highest risk, requires comprehensive clinical evaluation, quality systems, and CDSCO approval with ongoing surveillance

SaMD addressing serious healthcare situations or directly influencing clinical decision-making typically fall into Classes C or D.

Update the 'Regulatory pathway' section to include: 'As of 2024, CDSCO has not yet published a dedicated SaMD guidance document. Manufacturers should refer to the IMDRF SaMD Classification Framework (N12FINAL) for risk-based classification pending final CDSCO guidance release. Check the Digital Health & SaMD page for the latest updates on guidance publication timelines.'