India CDSCO Technical Dossier Kit

A CDSCO application centres on two master files: the Device Master File (DMF) and the Plant Master File (PMF). This kit gives you both as structured, fill-in Word templates that follow the Medical Device Rules 2017 appendices.

The DMF template embeds the essential-principles checklist as a dedicated section, each principle cross-referenced to the matching EU MDR GSPR — so a CE file can be carried across efficiently.

What’s inside

Four files — a README, the two master files and an index:

• IN-00 README — how the kit is structured and how to complete it.
• IN-DMF — Device Master File (Appendix II structure), with the essential-principles checklist embedded and GSPR-mapped.
• IN-PMF — Plant/Site Master File (Appendix I structure).
• IN-IDX Master Index (Excel) — a control sheet tracking both files.

Why it works

• Straight from the regulations. Every item is traced to the regulation, annex or guidance it comes from — not a second-hand summary.
• DMF and PMF in the right structure. Templates follow the Medical Device Rules 2017 appendices, so the master files read the way CDSCO expects.
• EU GSPR cross-referenced. Essential requirements point to the matching EU MDR GSPR, so you can locate and reuse evidence from an existing CE technical file.
• Built to be completed. Colour-coded fill-in fields, dropdowns and a clean print layout — designed to be worked in, not just read.

How to use it

1. Start from the README to understand the DMF and PMF structure.
2. Complete the Device Master File, including the embedded essential-principles checklist.
3. Complete the Plant Master File for your manufacturing site.
4. Track both in the master index, delete the guidance notes and assemble for your Authorised Agent.

Who it’s for

• Manufacturers preparing a CDSCO application
• RA consultants building the DMF and PMF
• Indian Authorised Agents assembling the master files on a manufacturer’s behalf

Specifications

Frequently asked questions