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Technical Documentation

Indian technical documentation requirements are based on the IMDRF STED (Summary Technical Documentation) format.

Core technical file contents​

  • Device description and intended use;
  • Summary of design and manufacturing;
  • Essential Principles checklist (Schedule 4, MDR 2017);
  • Risk management file (ISO 14971);
  • Pre-clinical and clinical performance data;
  • Labelling specimens;
  • Post-market surveillance plan.

Official source: Medical Devices Rules 2017, Schedule 4; IMDRF STED guidance

Device Description Requirements:

The device description must include: product name and brand name; device classification (Class A/B/C/D); intended use and indication for use; device type and physical description; operational principle and performance characteristics; materials in contact with patient or user; shelf life and storage conditions; and list of reference standards applied. Diagrams, drawings, or photographs should accompany the description.