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Samd

Official sources: CDSCO; ABDM — NHA; IMDRF

Overview​

Software as a Medical Device (SaMD) is standalone software that performs a medical function without being part of a hardware medical device. In India, SaMD is regulated by CDSCO under the Medical Devices Rules 2017.

Current Regulatory Status​

As of 2026, CDSCO has not published a dedicated SaMD guidance document. SaMD is classified using existing MDR 2017 categories (Class A, B, C, D) based on risk and clinical context. CDSCO has signaled intent to align with IMDRF SaMD guidance (documents N12 and N23).

SaMD Qualification Categories (Based on IMDRF Framework)​

  • Category 1: Software for non-clinical context (data management, patient engagement)
  • Category 2: Software providing recommendations to healthcare professionals
  • Category 3: Software providing autonomous function for diagnosis or monitoring
  • Category 4: Software for treatment or prognosis decisions

Clinical Validation Requirements​

  • Performance data: Sensitivity, specificity, accuracy, and predictive values
  • Clinical evidence: Published literature, clinical trials, or real-world performance data
  • Algorithm transparency: Documentation of training data, validation datasets, and performance across population subgroups
  • Risk analysis: FMEA or equivalent hazard analysis

Submission Requirements​

  • Software design and development documentation
  • Testing and validation reports
  • Risk management file
  • Cybersecurity documentation
  • Labeling and instructions for use