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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

Labelling and IFU Requirements

Under Schedule 4 of the Medical Devices Rules 2017, medical device labels and Instructions for Use must include:

• Device name, model, and batch/serial number; • Intended use and user population; • Contraindications, warnings, and precautions; • Instructions for safe use, storage, and handling; • Manufacturer details (name, address, contact information); • Regulatory approval/licence number (if applicable); • Expiry date or shelf life (if applicable); • Sterilisation method and conditions (for sterile devices); • Disposal instructions.

Labels must be in English and, where applicable, in local/regional Indian languages. IFUs must be clear, comprehensive, and accessible to the intended user. Labelling specimens must be submitted as part of the technical documentation for pre-market approval.