SFDA Saudi Gap Analysis

Name: SFDA Saudi Gap Analysis - MD Regulatory
SKU: MDR-SA-GAP
Price: 149.00 EUR
Availability: InStock

€149.00

SKU MDR-SA-GAP Category Saudi Arabia Tags gap analysis, MDMA, MDS-REQ 1, medical devices, Saudi Arabia, SFDA

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

SFDA · MDS-REQ-001 · MDMA Saudi Route

SFDA Saudi Gap Analysis

Every requirement of MDS-REQ-001 scored against your own evidence, with a dashboard that says DO NOT FILE until the file is actually ready.

€149

VAT calculated at checkout

Get the workbook

20 worksheets · 144 requirements
· Excel
Instant download · yours to keep

A Saudi file usually fails for something the manufacturer already had

The evidence exists in the CE technical file, but nobody mapped the essential principles onto it, so it is rewritten from scratch or filed incomplete. The Authorised Representative is appointed late, after the submission has already been prepared around a date that assumed otherwise. The ISO 13485 certificate has a scope that does not cover the device being registered, and it is noticed by the reviewer rather than by the manufacturer.

These are not judgement calls. They are items that either are or are not resolved, and the cost of finding out in a deficiency letter is a submission cycle.

The workbook makes each of them an explicit question with an answer recorded against it, before anything goes in.

20 worksheets
144 evaluable requirements
Microsoft Excel
Class A to D
Filing gate built in
Instant download

Scope

What the workbook covers

It covers the MDMA Saudi Route, the full technical file assessment under MDS-REQ-001, for non-IVD medical devices of every class. Each of the 144 items is traced to the regulation, annex or guidance it comes from, not to a second-hand summary of it.

The requirements

Essential principles, technical documentation, clinical evidence, quality management system, labelling, vigilance and UDI — scored Yes, No, Partial or N/A, with your evidence recorded next to each one.

The blockers

Killer items are separated from the rest: the Authorised Representative, the ISO 13485 prerequisites and the other conditions that stop a filing regardless of how complete everything else is.

The reuse

Essential principles are cross-referenced to the matching EU MDR general safety and performance requirements, so evidence already written for a CE file can be located and reused rather than rebuilt.

Contents

20 worksheets, in seven blocks

01InstructionsHow the scoring and the gate work

02Class & RouteClass A to D and the MDMA Saudi Route

03DashboardLive counts and the DO-NOT-FILE gate

04Killer ItemsAuthorised Representative, ISO 13485 and other blockers

05Requirement sheetsEssential principles, technical documentation, clinical, QMS, labelling, vigilance, UDI

06Client QuestionsWhat to ask the manufacturer, in the order you need it

07ReferencesThe regulatory register behind every item

Audience

Who the workbook is for

Manufacturers preparing a first SFDA marketing authorization
Regulatory affairs consultants who want a ready-made scaffold rather than a blank sheet
Saudi Authorised Representatives assembling a file on a manufacturer’s behalf
Quality and regulatory teams pressure-testing a file before it is submitted

It assumes you have a technical file, or are building one, and that you know what the documents in it are. It does not assume any prior work with SFDA.

What is included

What you get when you buy

One Excel workbook (.xlsx), 20 worksheets, 144 evaluable requirements
A dashboard with live counts and the DO-NOT-FILE gate
Colour-coded fill-in fields, dropdowns and a clean print layout
Cross-references from the essential principles to the EU MDR GSPR
A reference sheet citing the source of every item
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.

What is the filing gate?

A dashboard formula 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.

Do I need a Saudi Authorised Representative?

Yes. A foreign manufacturer files through a Saudi-resident Authorised Representative. The workbook prepares and de-risks the file; the Authorised Representative submits it.

Does it cover in vitro diagnostics?

No. The scope is non-IVD medical devices, Class A to D. IVDs follow a different set of SFDA requirements and are not addressed here.

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

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

Is it locked or protected?

No. It is a working Excel file. You can add sheets, change wording and adapt it to how your organisation records evidence.

Can I use it on more than one device?

Yes. The licence is for single-organisation use, and there is no limit on how many device files you run through it. Keep one copy per submission.

What if the SFDA 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 requirements against the SFDA site before you file.

Is this regulatory advice?

No. It is a documentation tool. It does not replace a Saudi Authorised Representative, nor case-specific verification against the SFDA requirements in force on the day you submit.

Can my company buy several copies?

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

Workbook and kit

The workbook tells you what is missing. The template is where it goes.

Scoring a 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 Saudi Arabia Technical Documentation Kit. The two are also sold together as the Full Saudi Arabia Market Access Kit, which costs less than buying them separately.