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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

Biocompatibility Testing Standards:

Biocompatibility testing must follow ISO 10993 series standards relevant to the device's contact duration and body location (surface contact, external communication, implantation). Testing includes: cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, and implantation reactions as applicable. For imported devices, foreign test reports must be accompanied by scientific justification or India-specific testing where required.