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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

CDSCO · Medical Device Rules 2017 · DMF and PMF

India CDSCO Gold Kit

Score the file, then build it. The gap analysis and the Device and Plant Master File templates, in one download.

€349

VAT calculated at checkout

Get the Gold Kit

5 files · 162 scored items · Word and Excel
Instant download · yours to keep

Two halves of the same job, usually done as two disconnected ones

A team assesses the file against the Medical Device Rules, produces a list of gaps, and then starts writing the Device Master File from a blank document with the list open in another window. The mapping between the two is done by hand, and by memory.

What follows is predictable. Items scored as partial never become sections. Evidence already written for the CE file is rewritten because nobody traced it to the Indian requirement it answers. The Authorised Agent receives a dossier that does not obviously correspond to the assessment behind it.

The two kits here are built to be used in sequence, on the same requirement register, so the output of the first is the outline of the second.

  • 2 kits, 5 files
  • 162 evaluable items
  • 20 worksheets
  • DMF and PMF templates
  • Filing gate built in
  • Instant download

Scope

What the Gold Kit covers

It covers a CDSCO application under the Medical Device Rules 2017, from assessment through to the master files an Authorised Agent submits. Every item is traced to the rule, schedule or guidance it comes from, rather than to a second-hand summary of it.

01

Assess

A 20-sheet scored workbook covering 162 items, with a dashboard that returns DO NOT FILE while any killer item is unresolved — so an incomplete file is caught before it reaches the authority.

02

Assemble

Device Master File and Plant Master File templates with guidance notes and evidence tables, plus a README and a master index tracking every document, its status and its revision.

03

Reuse

The essential principles are cross-referenced to the matching EU MDR general safety and performance requirements, so evidence written for a CE technical file can be located and reused instead of rebuilt.

Contents

Five files, two kits

ExcelIndia CDSCO Gap Analysis20 worksheets, 162 scored items, dashboard and DO-NOT-FILE gate
WordDevice Master File templateDevice description, design, essential principles, risk, V&V, clinical
WordPlant Master File templateSite, quality system, processes, controls
WordREADMEHow the two kits fit together and how to complete them
ExcelMaster IndexControl sheet: every document, its status and revision

Audience

Who the Gold Kit is for

  • Manufacturers preparing a complete CDSCO application
  • Regulatory affairs consultants who want the whole India toolkit in one purchase
  • Indian Authorised Agents assembling a file on a manufacturer’s behalf
  • Teams that will reuse the same method across several devices

It assumes the underlying evidence exists, or is being produced. It is an assessment and a structure, not a substitute for the studies and records that go inside the master files.

What is included

What you get when you buy

  • The India CDSCO Gap Analysis, normally €149
  • The India CDSCO Technical Dossier Kit, normally €249
  • Five files in total: one scored Excel workbook, three Word templates, one Excel index
  • Essential principles cross-referenced to the EU MDR GSPR
  • Guidance notes, bracketed prompts and evidence tables throughout
  • Instant download after purchase, licensed for single-organisation use

Bought separately the two kits come to €398. Together they are €349.

Questions

Before you buy

What do I save against buying them separately?

The two kits are €398 bought individually. The Gold Kit is €349, so you save €49 and get them in a single download.

Do I still need an Authorised Agent?

Yes. A foreign manufacturer applies through an Indian Authorised Agent, which submits the application and holds the licence. The Gold Kit prepares and de-risks what they submit.

What is the filing gate?

A dashboard formula in the gap analysis that returns DO NOT FILE while any mandatory killer item is unresolved. It is the difference between a checklist you can finish with gaps in it and one you cannot.

Can I buy only one of the two kits?

Yes, both are sold on their own. The Gold Kit exists because the assessment and the master files are the same job in two stages, and the second is much faster when the first has already been scored.

I already have a CE technical file. Does that help?

Considerably. The essential principles are cross-referenced to the matching EU MDR requirements, so for many items the work is locating existing evidence and recording where it sits rather than producing anything new.

Are the files editable?

Yes. Fully editable Word templates and Excel workbooks, nothing locked or protected. You can add sections and adapt the wording to how your organisation records evidence.

Can I use it on more than one device?

Yes. The licence is for single-organisation use, with no limit on how many applications you build from it. Keep one completed set per submission.

What if the rules change?

The current version is 1.0, dated 2026, built on the Medical Device Rules 2017. Revisions issued after your purchase are available to you at no further cost, and you should still verify the current requirements before you file.

Is this regulatory advice?

No. These are documentation tools. They do not replace an Indian Authorised Agent or case-specific verification against the rules in force on the day you apply.

Can my company buy several copies?

The licence already covers your organisation. If you need a purchase order or an invoice with specific details, get in touch and we will arrange it.

Assess and assemble

The workbook tells you what is missing. The templates are where it goes.

Scoring the file produces a list of items marked No or Partial. Most of them are documents rather than decisions, and each one has a section already waiting for it in the Device or Plant Master File. That is the whole reason the two are sold together: the gap list is the outline of the dossier.

India CDSCO Gold Kit

Gap analysis and Technical Dossier Kit in one download.
Five files, 162 scored items. Instant download, yours to keep.

Get the Gold Kit — €349

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

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Alessandro Stella

Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With 15+ 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.