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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: AI-based diagnostic imaging analysis software, clinical decision support tools with direct clinical impact, remote patient monitoring software with therapeutic functions.

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.