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Full India Market Access Kit

Full India Market Access Kit

Original price was: €398.00.Current price is: €349.00.

SKU MDR-IN-GOLD Category Tags , , , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

Everything to prepare a CDSCO application: score your file with the gap analysis, then build the Device and Plant Master Files from the templates.

Bought together as the Gold Kit, they save you compared with buying them separately.

What’s inside

Both India kits, in one download:

  • India CDSCO Gap Analysis — 20-sheet scored workbook, 162 items, with the DO-NOT-FILE gate.
  • India CDSCO Technical Dossier Kit — DMF and PMF templates (with GSPR-mapped essential principles), README and master index.

Why it works

  • Assess, then assemble. Score the file with the gap analysis, then build the master files — one coherent workflow.
  • 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.
  • 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.
  • Straight from the regulations. Every item is traced to the regulation, annex or guidance it comes from — not a second-hand summary.

How to use it

  1. Start with the gap analysis to see where your file stands.
  2. Build the Device and Plant Master Files from the templates.
  3. Reuse CE evidence via the GSPR-mapped essential principles.
  4. Resolve every killer item, then hand a filing-ready file to your Authorised Agent.

Who it’s for

  • Manufacturers preparing a complete CDSCO application
  • RA consultants who want the full India toolkit in one purchase
  • Teams that will reuse the method across multiple devices

What the bundle includes

  • India CDSCO Gap Analysis — normally €149
  • India CDSCO Technical Dossier Kit — normally €249

Bought separately these come to €398. As the Gold Kit they are €349 — a saving of €49.

Specifications

Format Excel (.xlsx) + Word (.docx)
Included kits Gap analysis + Technical Dossier Kit (DMF/PMF)
Files 5 in total
Regulatory basis Medical Device Rules 2017 (CDSCO)
Language English
Delivery Instant download after purchase
Licence Single-organisation use; yours to keep
Version 1.0 · 2026
Good to know. These are documentation tools, not regulatory advice, and do not replace an Indian Authorised Agent or case-specific verification.

Frequently asked questions

What do I save versus buying separately?

The two kits are €398 bought individually; the Gold Kit is €349, a saving of €49.

Do I still need an Authorised Agent?

Yes. The bundle prepares and de-risks the file; an Indian Authorised Agent still submits it.

Original price was: €398.00.Current price is: €349.00.

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Picture of Alessandro Stella

Alessandro Stella

Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.