Technical Documentation
Indian technical documentation requirements are based on the IMDRF STED (Summary Technical Documentation) for pre-market approval format, as specified in Schedule 4 of the Medical Devices Rules 2017.
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