Saudi Arabia Technical Documentation Kit

Name: Saudi Arabia Technical Documentation Kit - MD Regulatory
SKU: MDR-SA-TDK
Price: 249.00 EUR
Availability: InStock

€249.00

SKU MDR-SA-TDK Category Saudi Arabia Tags Annex 3, MDS-REQ 1, medical devices, 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

Saudi Arabia Technical Documentation Kit

The Annex 3 documentation as a structured, fill-in template, with the essential principles built in as Section 4 and mapped one to one onto the EU MDR.

€249

VAT calculated at checkout

Get the kit

3 files · Annex 3 template · Word and Excel
Instant download · yours to keep

The evidence exists. The Saudi file does not

A manufacturer with a CE-marked device has the design outputs, the risk file, the verification reports and the clinical evaluation. What it does not have is documentation in the shape Annex 3 asks for, and the distance between those two things is structure, not content.

So the work starts on a blank document. Sections get invented in the order they come to mind, the essential principles are kept in a separate spreadsheet that drifts out of step with the file it is supposed to describe, and evidence already written for the CE technical file is rewritten because nobody traced it to the Saudi requirement it answers.

The template is the shape, already built: the sections in the order Annex 3 sets out, with a note in each one saying what belongs there.

3 files
Annex 3 structure
Word and Excel
Essential principles as Section 4
GSPR mapped 1:1
Instant download

Scope

What the kit covers

It covers the Annex 3 technical documentation required for a marketing authorization on the MDMA Saudi Route, for non-IVD medical devices. Every item is traced to the regulation, annex or guidance it comes from, rather than to a second-hand summary of it.

The structure

The full Annex 3 outline as a Word template, in the order the documentation is assessed, with guidance notes, bracketed prompts and evidence tables in every section rather than empty headings.

The essential principles

Embedded as Section 4 of the documentation, not kept as a separate checklist. That is where a reviewer looks for them, so that is where they are written and where the evidence is cited.

The 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

Three files

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

WordREADMEHow the kit is structured and how to complete it

ExcelMaster IndexControl sheet: every document, its status and revision

Audience

Who the kit is for

Manufacturers preparing the technical documentation for an SFDA marketing authorization
Regulatory affairs consultants who want a submission-ready structure rather than a blank page
Saudi Authorised Representatives assembling documentation on a manufacturer’s behalf
Teams standardising how their technical files are structured across markets

It assumes the underlying evidence exists, or is being produced. It is a structure for the documentation, not a substitute for the studies and records that go inside it.

What is included

What you get when you buy

The Annex 3 technical documentation template, in Word
The essential principles built in as Section 4, mapped one to one onto the EU MDR GSPR
Guidance notes, bracketed prompts and evidence tables throughout
A README explaining the structure and how to complete it
An Excel master index for document status and revision control
Instant download after purchase, licensed for single-organisation use

Questions

Before you buy

Which route is it built for?

The MDMA Saudi Route, the full technical file assessment under MDS-REQ-001. It is the single pathway for all classes, so there is no route selection to get wrong.

Where do the essential principles sit?

Inside the 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, with the evidence cited in place.

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 sections the work is citing existing evidence rather than producing anything new.

Does it tell me whether my file is complete?

Not on its own. The template gives you the structure to fill; the SFDA Saudi Gap Analysis scores 144 items against your file and flags the blockers. The two are sold together as the Full Saudi Arabia Market Access Kit.

Does every class need this much documentation?

No. A Class A device that is not sterile, measuring, reusable surgical or novel can be filed on the abbreviated set. Everything else — Class A in those categories, and all of Class B, C and D — goes through the full Technical File Assessment, which is what the template is built for.

Do I still need an Authorised Representative?

Yes. A foreign manufacturer files through a Saudi-resident Authorised Representative, which holds an establishment licence and submits the application electronically on the GHAD system. The kit prepares what they submit.

Are the files editable?

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

What language is the file in?

English. Documentation is submitted to the SFDA in English through the Authorised Representative, so the template is written in the language you will file in. The MDMA certificate itself is issued in Arabic and English.

Can I use it on more than one device?

Yes. The licence is for single-organisation use, with no limit on how many files 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 templates. They do not replace a Saudi Authorised Representative or case-specific verification against the requirements in force on the day you submit.

Template and workbook

The template is where the documentation goes. The workbook tells you what is still missing from it.

Writing into a structure is faster than inventing one, but it does not tell you whether the file is ready. The SFDA Saudi Gap Analysis scores 144 items and returns DO NOT FILE while any killer item is unresolved. Both are included in the Full Saudi Arabia Market Access Kit, which costs less than buying them separately.