India CDSCO Gap Analysis

Licensing a medical device with the CDSCO under the Medical Device Rules 2017 means satisfying a long list of requirements across classification, the Device Master File, the Plant Master File, essential principles and more.

This workbook scores your file against every one of them. Mark each item, record your evidence, and a live dashboard shows how far the file is from ready — and whether any killer item blocks the application.

What’s inside

20 worksheets, 162 evaluable requirements, one Excel file:

• Instructions and Class & Route — Class A–D and the licensing route each demands.
• Dashboard — live counts and the DO-NOT-FILE gate.
• Killer items — the mandatory items that block the application.
• Requirement sheets — DMF, PMF, essential principles, risk, clinical, labelling, QMS, post-market and more.
• Client questions & References — what to ask, and the regulatory register behind every item.

Why it works

• A filing gate, not just a list. The dashboard returns DO NOT FILE while any killer item is unresolved, so you never submit an incomplete file by accident.
• 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.
• Straight from the regulations. Every item is traced to the regulation, annex or guidance it comes from — not a second-hand summary.
• 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. Confirm the device class and route on the Class & Route sheet.
2. Score each requirement Yes / No / Partial / N/A and record your evidence.
3. Watch the dashboard flag gaps and killer items in real time.
4. Resolve every blocker, then hand a clean, filing-ready file to your local representative.

Who it’s for

• Manufacturers preparing a first CDSCO application
• RA consultants who want a rigorous, ready-made scaffold
• Indian Authorised Agents assembling a file on a manufacturer’s behalf
• QA/RA teams pressure-testing a file before it goes in

Specifications

Frequently asked questions