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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.

Labelling specimens must be submitted in their final commercial form and include all text, images, symbols, and QR codes as they will appear on the device or packaging. Digital copies (high-resolution PDFs or images) should accompany physical samples. For multi-language labels, specimens for each language variant must be provided separately.