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Full Saudi Arabia Market Access Kit

Name: Full Saudi Arabia Market Access Kit - MD Regulatory
SKU: MDR-SA-GOLD
Price: 349.00 EUR
Availability: InStock

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

SKU MDR-SA-GOLD Category Saudi Arabia Tags Bundle, gap analysis, gold kit, MDMA, Saudi Arabia, SFDA, technical documentation

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

SFDA · MDS-REQ-001 · MDMA Saudi Route · Annex 3

Full Saudi Arabia Market Access Kit

Score the file, then build it. The gap analysis and the Annex 3 technical documentation template, in one download.

€349

VAT calculated at checkout

Get the Market Access Kit

4 files · 144 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 MDS-REQ-001, produces a list of gaps, and then starts writing the Annex 3 documentation 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 Saudi requirement it answers — even though the essential principles carry the same numbering as EU MDR Annex I. The Authorised Representative receives a file 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, 4 files
144 evaluable items
20 worksheets
Annex 3 template
Filing gate built in
Instant download

Scope

What the Market Access Kit covers

It covers a marketing authorization on the MDMA Saudi Route, from assessment through to the Annex 3 technical documentation an Authorised Representative submits. Every item is traced to the regulation, annex or guidance it comes from, rather than to a second-hand summary of it.

Assess

A 20-sheet scored workbook covering 144 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.

Assemble

The Annex 3 template, with the essential principles embedded as Section 4 rather than kept as a separate checklist, plus a README and a master index tracking every document, its status and its revision.

Reuse

The SFDA essential principles share the numbering of EU MDR Annex I, so the mapping is one to one and evidence written for a CE technical file transfers directly instead of being rebuilt.

Contents

Four files, two kits

ExcelSFDA Saudi Gap Analysis20 worksheets, 144 scored items, dashboard and DO-NOT-FILE gate

WordAnnex 3 Technical Documentation templateFull structure, with the essential principles embedded as Section 4

WordREADMEHow the two kits fit together and how to complete them

ExcelMaster IndexControl sheet: every document, its status and revision

Audience

Who the Market Access Kit is for

Manufacturers preparing a complete SFDA marketing authorization
Regulatory affairs consultants who want the whole Saudi toolkit in one purchase
Saudi Authorised Representatives 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 documentation.

What is included

What you get when you buy

The SFDA Saudi Gap Analysis, normally €149
The Saudi Arabia Technical Documentation Kit, normally €249
Four files in total: one scored Excel workbook, two Word documents, one Excel index
Essential principles mapped one to one onto 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 Market Access Kit is €349, so you save €49 and get them in a single download.

Do I still need an Authorised Representative?

Yes. A foreign manufacturer files through a Saudi-resident Authorised Representative, which submits the application. The Market Access 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 Market Access Kit exists because the assessment and the documentation 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?

More than in most markets. The SFDA essential principles use the same numbering as EU MDR Annex I, so the mapping is one to one and for many items the work is recording where existing evidence sits rather than producing anything new.

Where do the essential principles sit?

Inside the Annex 3 template, as Section 4, rather than in a separate checklist file. That is how the documentation is assessed, so that is how it is written.

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 requirements change?

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

Is this regulatory advice?

No. These are documentation tools. They do not replace a Saudi Authorised Representative or case-specific verification against the requirements in force on the day you submit.

Assess and assemble

The workbook tells you what is missing. The template is 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 Annex 3 template. That is the whole reason the two are sold together: the gap list is the outline of the documentation.